>> THIS IS ONGOING, OBVIOUSLY,
BUT WE'RE TAKING THIS VERY
SERIOUSLY, AND WE'RE VERY
COMMITTED TO REALLY ADDRESSING
ANY ISSUES THAT WE -- THAT, YOU
KNOW, WE GATHER FROM THIS RFI,
IN THE BEST POSSIBLE WAY.
THE NEXT -- OOPS.
IT'S NOT ADVANCING, THE SLIDES
HERE.
AM I SUPPOSED TO?
CAN YOU ADVANCE IT FOR ME?
YES.
THE NEXT ITEM I WANT TO MENTION
IS THE CREATION OF A NEW NIH
OFFICE OF AUTOIMMUNE DISEASE
RESEARCH AT NIH, OADR, AND THIS
IS UNDER THE OFFICE OF RESEARCH
FOR WOMEN'S HEALTH AT THE OFFICE
OF THE DIRECTOR.
AND THIS IS IN RECOGNITION OF --
THE REASON WHY IT'S UNDER THE
OFFICE OF RESEARCH IN WOMEN'S
HEALTH BECAUSE AUTOIMMUNE
DISEASES AND CONDITIONS
DISPROPORTIONATELY AFFECT WOMEN,
AND THIS IS AN EFFORT TO CREATE
MORE SORT OF CROSS-CUTTING
KNOWLEDGE DEVELOPMENT ACROSS
THESE VARIOUS DISEASES THAT VERY
OFTEN GET -- YOU KNOW, ACTUALLY
GET LOOKED AT SEPARATELY,
DISEASES, FOR EXAMPLE, LIKE
LUPUS OR SHÖGREN'S SYNDROME,
SCLERODERMA, TEND TO BE
SEPARATED INTO THESE VARIOUS
CONDITIONS BUT WE LOOK AT, FOR
EXAMPLE, MOLECULAR MARKERS THAT
GO ACROSS THESE CONDITIONS,
THERE'S A LOT TO BE LEARNED BY
LOOKING AT THESE AS A WHOLE.
THERE WAS RECENTLY NOTICE OF
SPECIAL FROM IN RELATIONSHIP TO
THIS, EXPOSOME IN COLLABORATION
TEAM PLANNING I WARDS, EXACT.
WE'RE VERY INTERESTED IN THIS
OBVIOUSLY AT THE NIH-WIDE LEVEL.
NEXT SLIDE.
THE NEXT ITEM I WANT TO MENTION
IS THE ARPA-H HIRING A PROGRAM
MANAGER.
WE'VE TALKED ABOUT ARPA-H IN
PREVIOUS COUNCIL MEETINGS.
THIS IS A NEW ENTITY AT NIH THAT
IS GEARED TOWARDS THE RAPID
ACCELERATION OF DEVELOPMENT OF
TECHNOLOGIES AND SORT OF
TRANSLATION TO COMMERCIAL
DEVELOPMENT TO IMPROVE THE
HEALTH OF ALL.
AND INTERESTINGLY, SO THE FOUR
FOCUS AREAS, OF THE FOUR FOCUS
AREAS HIGHLIGHTED TWO ARE
RELEVANT TO NCCIH, ONE BEING
PRO-ACTIVE HEALTH, KEEPING
PEOPLE FROM BECOMING PATIENTS,
AND THE OTHER IS RESILIENCE
SYSTEMS, BUILDING INTEGRATED
HEALTH CARE SYSTEMS, AS YOU CAN
SEE THIS IS VERY MUCH IN THE
SAME SPIRIT AS OUR WHOLE PERSON
HEALTH STRATEGIC PLAN.
AND SO, THE HIRING OF THESE
PROGRAM MANAGERS IS A VERY
INTERROGATORY PROCESS, BASICALLY
LOOKING FOR INDIVIDUALS FROM THE
COMMUNITY AS WELL AS WITHIN NIH
WHO ARE PASSIONATE ABOUT A
SPECIFIC VISION FOR MAKING
SOMETHING HAPPEN FAST.
AND THIS IS A KEY COMPONENT OF
ARPA-H, AS THIS IS MEANT TO
REALLY ACCELERATE PROGRESS IN
SPECIFIC AREAS, SO THESE PROGRAM
MANAGERS WILL HAVE -- WILL BE
EMPOWERED ESSENTIALLY TO DEVELOP
REVOLUTIONARY SOLUTIONS TO SOLVE
PROBLEMS, AND SO THEY ARE HIRING
NOW.
SO IF YOU'RE AWARE OF ANY
INDIVIDUALS WHO MIGHT BE
INTERESTED IN THIS, MIGHT BE
QUALIFIED, LET THEM KNOW.
NEXT SLIDE PLEASE.
STILL IN THE SORT OF DOMAIN OF
SCIENCE AND TECHNOLOGY, VERY
IMPORTANT INITIATIVE WHICH IS
THE STRIDES INITIATIVE, ABOUT --
TO HELP INVESTIGATORS TO KIND OF
MAKE THE STEP AND UTILIZE CLOUD
SERVICES AND TECHNOLOGIES FOR
DATA STORAGE, DATA MANAGEMENT,
THIS IS SOMETHING THAT NIH IS
REALLY PUTTING A LOT OF EFFORT
TO DO THE ODSS, OR THE OFFICE OF
DATA STRATEGY AT THE NIH-WIDE
LEVEL, IS REALLY ENCOURAGING AND
REALLY PROVIDING RESOURCES TO
GIVE, FOR EXAMPLE, DISCOUNTS TO
USE CLOUD SERVICES TO
INVESTIGATORS, WELL WORTH
CHECKING THESE OUT.
NEXT SLIDE PLEASE.
COVID, SO WE ALWAYS HAVE A COVID
SECTION IN THIS REPORT.
AND IT'S VERY INTERESTING THIS
COINCIDES WITH I BELIEVE
YESTERDAY THE ENDING OF THE
EMERGENCY STATUS FOR COVID IN
THIS COUNTRY.
NOW, NOBODY'S KIDDING OURSELVES
THAT THIS PANDEMIC IS ACTUALLY
OVER.
NOBODY'S SAYING THAT.
ON THE OTHER HAND, IT DOES FEEL
LIKE WE'RE MAKING PROGRESS, AND
THE FACT WE'RE ALL IN HERE IN
THIS ROOM I THINK ATTESTS TO
THAT.
AND I'M GOING TO JUST SAY FROM
PERSONAL STANDPOINT, I KNOW A
LOT OF PEOPLE FEEL THIS WAY, I
THINK ONE OF THE QUIET SORT
BLESSINGS THAT WE'VE KIND OF
RECEIVED FROM THE COVID PANDEMIC
IS AN INCREASED APPRECIATION FOR
BEING WITH OTHER PEOPLE IN
PERSON.
I THINK A LOT OF PEOPLE FEEL
THAT VERY VISCERALLY AND
PROFOUNDLY.
I KNOW I DO.
AND SO, YOU KNOW, IF WE CAN SAY
THANK YOU TO COVID FOR ONE
THING, I WOULD SAY IT'S THAT.
NEXT SLIDE.
I ALSO WANT TO SAY WE'RE VERY
SORRY ONE OF OUR RECENTLY
APPOINTED COUNCIL MEMBERS HAD TO
STEP DOWN FROM COUNCIL FOR
PERSONAL REASONS, BUT WE WILL
MISS HER DEARLY.
NEXT SLIDE.
IT'S NOW MY PLEASURE TO WELCOME
SOME NEW COUNCIL MEMBERS.
ALTHOUGH, YES, THESE INDIVIDUALS
WERE HERE ALREADY AT A PREVIOUS
COUNCIL MEETING BUT TODAY THEY
ARE HERE FOR THE FIRST TIME AT
THEIR OFFICIAL CAPACITY, SO I
WILL START WITH DR. HELENE
BENVENISTE.
WHAT HAPPENED IN THERE WE GO,
PROFESSOR IN THE DEPARTMENT OF
ANESTHESIOLOGY AT YALE, SCHOOL
OF MEDICINE, LABORATORY EXPLORES
FUNCTIONING OF GLYMPHATIC
SYSTEMS OR THE WASTE DISPOSAL
SYSTEM IN THE BRAIN.
SHE'S DEVELOPED IMAGING
PLATFORMS TO EXAMINE HOW
CEREBROSPINAL FLUID CIRCULATES
IN THE BRAIN, EXPLORES CRITICAL
PROCESSES SUCH AS BODY POSITION,
RESPIRATION, TYPE OF ANESTHESIA
AND BODY POSITION, WASTE
DISPOSAL ACROSS HEALTHY BRAIN
AND NEURODEGENERATIVE DISEASES,
THE OVERALL GOAL OF HER PROGRAM
IS TO DEVELOP THERAPEUTIC
STRATEGIES TO SUSTAIN OPTIMIZED
WASTE CLEARANCE THROUGH THE
GIVEN LIFESPAN TO PREVENT
DEMENTIA.
SO WELCOME.
NEXT SLIDE PLEASE.
THE OTHER NEW COUNCIL MEMBER,
DOCTOR OF OSTEOPATHIC MEDICINE,
VICE PROVOST, TEAM PHYSICIAN FOR
VIRGINIA TECH ATHLETICS AND U.S.
SKI TEAM, DR. BROLINSON RESEARCH
INTERESTS INCLUDED EXERCISE AND
IMMUNE FUNCTION, EXERCISE AND
BONE MINERAL DENSITY, MILD
TRAUMATIC BRAIN INJURY IN
SPORTS, IMPACT OF BIOMECHANICS,
HUMAN FACTORS IN AT AUTO SAFETY,
OSTEOPATHIC MANIPULATION.
NEXT SLIDE PLEASE.
NEXT IS DR. DANIEL DICKERSON,
ALSO A DOCTOR OF OSTEOPATHY,
ASSOCIATE RESEARCH PSYCHIATRIST
AT UCLA INTEGRATIVE SUBSTANCE
ABUSE PROGRAM, RESEARCH FOCUSES
ON DEVELOPMENT AND ANALYSIS OF
SUBSTANCE USE TREATMENT AND
PREVENTION PROGRAMS FOR AMERICAN
INDIAN, ALASKA NATIVE YOUTH AND
ADULTS, CONDUCTED RESEARCH ON
VARIOUS NIH FUNDED STUDIES,
NATIVE AMERICAN YOUTH SLEEP,
HEALTH AND WELLNESS,
MOTIVATIONAL INTERVIEWING AND
CULTURES FOR YOUTH, AND DRUM
ASSISTED RECOVERY THERAPY FOR
NATIVE AMERICANS.
SO WELCOME.
NEXT IS DR. ERICA SABENGA, M.D.,
ASSOCIATE PROFESSOR IN
DEPARTMENT OF PEDIATRICS, JOHNS
HOPKINS UNIVERSITY SCHOOL OF
MEDICINE, AN EXPERT IN PEDIATRIC
CLINICAL RESEARCH, FOCUS ON
DEVELOPING EVIDENCE FOR SENSIBLE
INTEGRATION OF COMPLEMENTARY
APPROACHES IN PEDIATRIC CARE,
HER MINDFULNESS PROGRAMS FOR
URBAN YOUTH IN CLINIC AND
SCHOOL-BASED STUDIES ARE AN AREA
OF FOCUS, MINDFULNESS
PROGRAMMING FOR URBAN TEACHERS
AND MOTHERS OF INFANTS IN
NEONATAL INTENSIVE CARE UNITS,
AND PROGRAMS FOR VULNERABLE
ADOLESCENTS WITH TYPE 1
DIABETES, INFLAMMATORY BOWEL
DISEASE, HOMELESS YOUTH.
SO WELCOME.
DR. RHONDA MAGEE, SHOULD WE
ADDRESS YOU AS DOCTOR?
J.D., PROFESSOR OF LAW,
UNIVERSITY OF SAN FRANCISCO,
WHERE SHE TEACHES TORT INSURANCE
LAW, RACE IN AMERICAN LEGAL
HISTORY, CO-CREATED CON
TEMPLATIVE LAWYERING, THE AUTHOR
OF INNER WORK OF RACIAL JUSTICE,
HEALING OURSELVES AND
TRANSFORMING OUR COMMUNITIES
THROUGH MINDFULNESS.
SHE'S A PRACTICE INNOVATOR OF
SOCIAL JUSTICE PRINCIPLES,
CONCEPTS, PRACTICE, FOUNDING
DIRECTOR OF CENTER FOR CON
TEMPLATEIVE LAW, UNIVERSITY OF
SAN FRANCISCO.
NEXT, NEW EX OFFICIO COUNCIL
MEMBER CAPTAIN JAMES RUSSELL
LINDERMAN, Ph.D. IN EXERCISE
PHYSIOLOGY, A NAVAL AEROSPACE
AND OPERATIONAL PHYSIOLOGIST, AT
THE UNIFORMED SERVICE UNIVERSITY
SCHOOL OF MEDICINE, ALSO THE
DEPUTY DIRECTOR OF THE
CONSORTIUM FOR HEALTH AND
MILITARY PERFORMANCE OR CHAMP,
ALSO A DESIGNATED DEPARTMENT OF
DEFENSE CENTER OF EXCELLENCE
SPECIALIZING IN TOTAL FORCE
FITNESS AND HUMAN PERFORMANCE
OPTIMIZATION.
HIS PERSONAL AWARDS INCLUDE
DEFENSE MERITORIOUS SERVICE
MEDAL, MERITORIOUS SERVICE
MEDAL, AND NAVY AND MARINE CORPS
COMMENDATION MEDAL.
WELCOME AS WELL.
I NOW WANT TO GIVE YOU NCCIH
STAFF UPDATES.
WE HAVE SEVERAL NEW STAFF
ARRIVALS IN THE OFFICE OF
ADMINISTRATIVE OPERATIONS,
EXTRAMURAL ACTIVITIES,
EXTRAMURAL RESEARCH, AND
INTRAMURAL RESEARCH.
WE'RE ALWAYS EXCITED TO WELCOME
NEW MEMBERS TO NCCIH.
WE ALSO HAD DEPARTURES, LISTED
HERE.
I WANT TO HIGHLIGHT OUR NEW
DIRECTOR OF THE OFFICE OF
SCIENTIFIC REVIEW WHO IS
SUCCEEDED DR. SCHMIDT,
CONGRATULATIONS TO JESSICA, VERY
MUCH EXCITED SHE'S ASSUMING HER
NEW ROLE.
WE ALSO HAVE A NEW CAREER
POSITION OPEN THAT I WANT TO
TELL YOU ALL ABOUT.
THIS IS OUR POSITION OF FACILITY
HEAD, STAFF SCIENTIST, IN THE
NIH PAIN RESEARCH CENTER IN THE
DIVISION OF INTRAMURAL RESEARCH
AT NCCIH, AN IMPORTANT POSITION
THAT WILL HELP US GROW OUR
CENTER FOR PAIN RESEARCH THAT IS
A CENTER THAT REALLY INTERFACES
WITH ALL THE NIH INSTITUTES.
IT'S GOING TO REALLY GROW THE
FIELD OF PAIN RESEARCH IN NIH AS
A WHOLE.
NEXT SLIDE.
NOW TIME FOR BUDGET UPDATE.
AND SO THOSE NOT FAMILIAR WITH
THIS MECHANISM TABLE WE SHOW
THIS ALL THE TIME.
THERE'S A COUPLE THAT DON'T HAVE
TO LOOK AT EVERY SINGLE NUMBER
BUT WANT TO HIGHLIGHT.
WE HAD A NICE BUDGET INCREASE
THIS PAST YEAR.
ONE OF THE SPECIFIC ITEMS IN
THIS BUDGET INCREASE WAS $5
MILLION APPROPRIATED EARMARK TO
NCCIH FOR INCREASING OUR PAIN
RESEARCH, ACKNOWLEDGMENT OF
EFFORTS AND SUCCESS IN PAIN
RERESEVER.
CAN YOU SEE AT THE TOP A
COMPETING LINE, A NICE INCREASE
IN OUR COMPETING RESEARCH FROM
$19 MILLION TO $23 MILLION, SO
WE'VE BEEN ABLE TO INCREASE THAT
THIS YEAR SO WE'RE VERY HAPPY
ABOUT THAT.
I WANT TO POINT OUT ONE ITEM
TOWARDS THE BOTTOM IN OUR
CONTRACT LINE, WE'RE
CONTRIBUTING $1.5 MILLION TO AN
IMPORTANT ASPECT OF OUR
EPIDEMIOLOGY RESEARCH, WHICH IS
THE NATIONAL HEALTH INTERVIEW
SURVEY, NHIS.
WE CONTRACT TO THE CDC, AND THIS
GIVES US EXTREMELY IMPORTANT
INFORMATION ON THE UTILIZATION
OF COMPLEMENTARY AND INTEGRATIVE
PRACTICES THROUGHOUT THE
COUNTRY.
NEXT, I WANT TO POINT OUT
SOMETHING VERY IMPORTANT HERE IN
OUR -- NEXT SLIDE PLEASE -- HOW
SUCCESSFUL WE'VE BEEN OVER THE
PAST YEARS AT LEVERAGING FUNDS
FROM OTHER ICOS, TRANS-NIH
INITIATIVES.
IN GREEN OUR APPROPRIATED
BUDGET, MODESTLY GROWN, BUT THE
CONTRIBUTION FROM BOTH THE HEAL
INITIATIVE IN BLUE, YOU CAN SEE
HAS REALLY BEEN VERY NICE, $26
MILLION THIS YEAR FROM THE HEAL
INITIATIVE, IN ADDITION TO OUR
BUDGET.
AND THIS INCLUDES NEARLY $14
MILLION FOR AN INITIATIVE ON
MYOFASCIAL PAIN WHICH WE'VE
FUNDED THROUGH "HEAL," AND ALSO
$3.4 MILLION FOR BEHAVIORAL AND
SOCIAL INTERVENTIONS TO APPROVE
ADHERENCE TO MEDICATION-ASSISTED
TREATMENT FOR OPIOID USE
DISORDERS.
WE'RE HAPPY ABOUT THAT.
THE OTHER ITEMS IN RED SHOWN
HERE IS OUR CO-FUNDING FROM
OTHER INSTITUTES ON SOME OF THE
GRANTS THAT WE'RE FUNDING
THROUGH NCCIH, YOU CAN SEE
THAT'S VERY ROBUST AS WELL.
OUR BUDGET IS REALLY VERY WELL
SUPPLEMENTED BY ALL THE EFFORTS
THAT OUR STAFF PUT TOWARDS
PARTICIPATING IN THESE TRANS-NIH
INITIATIVES AND IT'S A LOT OF
WORK.
IT'S REALLY -- WE WANT TO GIVE
OUR STAFF A LOT OF CREDIT FOR
REALLY ESTABLISHING THESE
CONNECTIONS WITH THE OTHER
INSTITUTES, AND SECURING THESE
CO-FUNDS, ALSO PARTICIPATING IN
THESE TRANS-NIH PROGRAMS.
SO THIS IS AN AREA THAT WE'RE
VERY EXCITED ABOUT, AND VERY
MUCH HOPING THIS WILL CONTINUE
TO GROW.
NEXT SLIDE.
SO, NOW SOME PROGRAM NEWS FROM
WITHIN NCCIH.
I WANT TO REALLY CELEBRATE THE
LAUNCHING OF THE NIH MUSIC-BASED
INTERVENTION TOOLKIT.
NOW, THIS IS A RESOURCE THAT'S
AVAILABLE TO RESEARCHERS THAT
DEALS WITH -- PROVIDES A LOT OF
RESOURCES INCLUDING CORE SETS OF
COMMON DATA ELEMENTS, FUNCTIONAL
OUTCOME MEASURES, GUIDELINES FOR
INTEGRATED RESEARCH ON MUSIC AND
HEALTH.
THIS IS GOING TO BE A VERY
IMPORTANT RESEARCH GOING
FORWARD, AS WE'RE GROWING OUR
PORTFOLIO ON MUSIC AND HEALTH.
NEXT SLIDE PLEASE.
SO NOW I'LL HIGHLIGHT A FEW
RESEARCH SPOTLIGHTS WE MAY WANT
TO CHECK OUT AND READ.
NEXT SLIDE.
FIRST IS A VERY INTERESTING
STUDY ON THE IMPACT OF DIGITAL
MEDITATION ON WORK STRESS AND
HEALTH OUTCOME AMONG ADULTS WITH
OVERWEIGHT, RANDOMIZED
CONTROLLED TRIAL, AND FROM
THE -- PARTLY FROM THE
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES, UCSF, AND
ASSOCIATE A CENTER FOR
INTEGRATIVE MEDICINE AT
UNIVERSITY OF CALIFORNIA.
WHAT WAS FOUND IN THIS STUDY IS
IF YOU LOOK AT THE DIFFERENCES
BETWEEN THE DIFFERENT
INTERVENTION, HEALTHY EATING
WHICH IS MORE LIKE NUTRITIONAL
COUNSELING, BUT THEN ADDING
MINDFULNESS, MINDFULNESS
INTERVENTION TO THE NUTRITIONAL
INTERVENTION INCREASED ITS
EFFECTIVENESS NOT ONLY ON THE
STRESS OUTCOMES BUT ALSO ON THE
MEASURE OF OVERWEIGHT, WHICH IN
THIS CASE IS THE SAGITTAL
DIAMETER.
THIS IS PROMISING IN THE SENSE
WE'RE SEEING MINDFULNESS CANP BE
APPLIED TO VARIOUS ASPECTS OF
THE WHOLE PERSON.
NEXT SLIDES.
THIS IS AN INTERESTING STUDY
FROM A VARIETY OF DIFFERENT --
MOSTLY FROM STANFORD UNIVERSITY,
DIFFERENT GROUPS OF
INVESTIGATORS ON EFFECTS OF
WEARABLE FITNESS TRACKER AND
ACTIVITY, LOOKING AT THE MINDSET
OF THIS ON THE BEHAVIOR OF THE
PERSON AND THE INTERESTING THING
HERE IS THE WAY THEY DID IT, SO
THEY GAVE PEOPLE THESE ACTIVITY
TRACKERS AND THEN THEY ACTUALLY
FALSIFIED THE INFORMATION THE
TRACKER WAS GIVING THE PERSON.
WHEN PEOPLE WERE TAKING A
CERTAIN NUMBER OF STEPS AND TOLD
THEY WERE TAKING LESS STEPS IT
AFFECTED THEIR BEHAVIOR.
SO VERY INTERESTING STUDY
DESIGN.
I WOULD ENCOURAGE YOU TO CHECK
IT OUT IF YOU'RE INTERESTED.
AND THE NEXT SLIDE PLEASE.
THIS IS ALSO A REALLY
INTERESTING STUDY THAT LOOKED AT
THE EFFECTS OF ADMINISTERED --
CO-ADMINISTERED THC AND CBD, AND
DR. NADIA KETKI IS ONE OF THE
AUTHORS?
MAYBE NOT.
I GUESS NOT, SORRY.
WHAT THE INDIVIDUAL SAW, WHAT
RESEARCHERS FOUND HERE WAS QUITE
SURPRISING, THAT THE EFFECT OF
THE -- NEGATIVE EFFECT OF THE
THC EXACERBATED BY THE CBD, AND
SO THIS IS DUE TO THE FACT THE
METABOLISM OF THE THC IS ALTERED
BY THE PRESENCE OF CBD.
AND THIS IS INTERESTING TO KNOW
BECAUSE IT'S ALSO HAS A LOT TO
DO WITH THE DRUG INTERACTIONS
THAT CAN TAKE PLACE.
SO, ALSO VERY IMPORTANT STUDY TO
CHECK OUT.
NEXT SLIDE PLEASE.
I NOW WANT TO POINT OUT SOME
FUNDING OPPORTUNITIES.
THE FIRST IS A RESEARCH NETWORK
TO PROMOTE MULTI-DISCIPLINARY
MECHANISTIC AND TRANSLATIONAL
STUDIES OF SICKLE CELL DISEASE
PAIN.
THIS IS REALLY AS OPPOSED TO
SOME OF THE PRIOR INITIATIVES
THAT WE HAD THAT HAVE BEEN MORE
ON THE CLINICAL SIDE, THIS IS
REALLY LOOKING AT MECHANISMS OF
ACTION.
AND THIS FUNDING OPPORTUNITY
IS -- WAIT A MINUTE.
POSTED DATE, YES, THE DUE DATE
IS OCTOBER, SO THERE'S STILL
PLENTY OF TIME TO SUBMIT THIS.
AND THE ICCIH PROGRAM CONTACT IS
DR. BALFOUR.
THIS IS A NOTICE OF SPECIAL
INTERESTS, BRAIN INITIATIVE IS
ONE OF THE TRANS-NIH INITIATIVE.
WHEN WE SEE -- WE VERY MUCH WORK
WITH BRAIN TO CREATE THESE
INITIATIVES, FUNDING
OPPORTUNITIES THAT ARE RELEVANT
TO NCCIH, AND THIS IS ONE OF
THEM, NOTICE OF SUPPORT FOR
RESEARCH ON INTEROCEPTION
CIRCUITS.
WE'VE FUNDED SOME RESEARCH IN
THE PAST ON INTEROCEPTION.
THIS IS VERY IMPORTANT ASPECT OF
THE BODY IN WHICH THE BODY
PERCEIVES SIGNALS, INTERNAL
SIGNALS, AND PERCEIVES SIGNALS
FOR EXAMPLE COMING FROM YOUR GUT
OR YOUR LUNG OR OTHER SORT OF
VISCERA.
SO, THIS PARTICULAR INITIATIVE
IS ALSO OPEN UNTIL OCTOBER, AND
CONTACT IS DR. WEN CHEN.
THE NEXT SLIDE IS A NOTICE OF
SPECIAL INTEREST FOR GLOBAL
BRAIN AND NERVOUS SYSTEM
DISORDERS RESEARCH ACROSS THE
LIFESPAN.
AND THIS IS SPECIFICALLY TO
SEARCH FOR NEW SOURCES OF
NATURAL PRODUCTS THAT HAVE
ACTIVITY WITHIN THE BRAIN.
AND THIS IS IN COLLABORATION
WITH THE FOGARTY INTERNATIONAL
CENTER.
AND THE POINT OF CONTACT IS DR.
PATRICK STILL.
THESE ARE SOME FUNDING
OPPORTUNITIES THAT WE HAVE
SIGNED ON.
ONE IS A TRANS-NIH ACTIVITY TO
ADDRESS THE IMPACT OF STRUCTURAL
RACISM, AND DISCRIMINATION ON
MINORITY HEALTH AND HEALTH
DISPARITIES, SO THIS IS FOR
R01s WITH CLINICAL TRIAL
OPTIONAL.
THE POINT OF CONTACT IS DR. BEDA
JEAN-FRANCOIS.
NEXT SLIDE.
NOTICE OF SPECIAL INTEREST ON
SYNTHETIC BIOLOGY FOR BIOMEDICAL
APPLICATIONS.
AGAIN, THIS IS VERY IMPORTANT TO
DEVELOP TOOLS FOR NATURAL
PRODUCT RESEARCH AS WELL AS FOR
MIND AND BODY THERAPIES AND THIS
IS A LONGSTANDING PARTNERSHIP
THAT WE'VE HAD WITH THE NIBIB.
POINT OF CONTACT IS DR. HYE-SOOK
KIM.
NEXT IS ALSO A NOTICE OF SPECIAL
INTEREST, ADMINISTRATIVE
SUPPLEMENTS FOR OPEN TOOLS
SCIENCE.
AS WE'RE MOVING FORWARD WITH OUR
DEVELOPING OUR FUNDING
OPPORTUNITIES FOR DOING WHOLE
PERSON RESEARCH, IT'S VERY
IMPORTANT THAT OUR INVESTIGATORS
ARE FULLY EMPOWERED TO REALLY
MAXIMALLY UTILIZE BIG DATA SETS,
AND SHARING DATA, AND DEVELOPING
THE PLATFORMS THAT ARE AVAILABLE
TO DO THIS TO THEIR MAXIMUM
EFFECTIVENESS.
THIS IS ALSO -- THESE AWARDS ARE
THROUGH THE OFFICE OF DATA
SCIENCE AND STRATEGY, ODSS.
AND SO DR. HORGUSLUOGLU IS POINT
OF CONTACT ON THIS.
NEXT IS ANOTHER IMPORTANT NOTICE
OF SPECIAL INTEREST TO SUPPORT
COLLABORATION TO IMPROVE WHAT WE
CALL AI/ML READINESS.
WHEN DATA ARE FIRED FOR THE
PURPOSE OF ARTIFICIAL
INTELLIGENCE IT'S IMPORTANT
THESE DATA ARE ANNOTATED IN SUCH
A WAY THEY CAN BE USED TO DO
ARTIFICIAL INTELLIGENCE, AND SO
DATA NEED TO BE ACQUIRED WITH
A.I. IN MIND FROM THE START.
SO THIS IS WHAT THESE NOSIs
ARE ABOUT, AND DR. HORGUSLUOGLU
IS THE POINT OF CONTACT FOR
THIS.
NEXT SLIDE.
I WANT TO HIGHLIGHT SOME OF THE
PAST ACTIVITIES.
ONE IS WE HAD OUR NIH "HEAL"
INVESTIGATOR MEETING, ANNUAL
MEETING, FEBRUARY HERE IN PERSON
AT NIH.
IT WAS VERY SUCCESSFUL MEETING.
AND THIS WAS A WONDERFUL
OPPORTUNITY FOR "HEAL"
INVESTIGATORS TO MEET EACH OTHER
IN PERSON.
A LOT OF THEM HAD BEEN
INTERACTING WITH EACH OTHER
VIRTUALLY FOR QUITE A WHILE.
AND AFTER THE MEETING WE HAD A
VERY NICE ONE-DAY SYMPOSIUM WITH
THREE VERY IMPORTANT PROGRAMS IN
THE "HEAL" THAT WE -- ACTUALLY
FOUR OF THEM, THAT WE'RE VERY
MUCH PARTICIPATING.
ONE IS THE MYOFASCIAL PAIN
BIOMARKERS INITIATIVE, OTHER IS
REJOIN INITIATIVE, FOR
DELINEATING THE SENSORY
INNERVATION OF WHOLE JOINTS.
ANOTHER IS THE BACPAC INITIATIVE
FOR UNDERSTANDING MECHANISMS OF
BACK PAIN, AND THEN THE FINAL
ONE IS INITIATIVE FROM NINDS ON
DEVELOPING BIOMARKERS, TISSUE
BIOMARKERS.
AND SO WE HAD A MEETING OF THE
INVESTIGATORS WITH ALL THESE
FOUR PROGRAMS, IT WAS ABSOLUTELY
WONDERFUL TO SEE THE
CROSS-FERTILIZATION ACROSS THESE
PROGRAMS EVIDENT IN THE ROOM AS
WE WERE THERE, YOU KNOW,
WATCHING PEOPLE SORT OF CONNECT
ACROSS THESE FOUR PROGRAMS.
THIS IS GOING TO BE VERY
POWERFUL AS IT GOES FORWARD, AS
WE GROW OUR PORTFOLIO ON
MUSCULOSKELETAL RESEARCH, PAIN
RESEARCH.
NEXT SLIDE.
THE BRIDGE TO A.I. IS ANOTHER
INITIATIVE, COMMON FUND,
TRANS-NIH INITIATIVE, WHICH
IS -- IT'S CALLED BRIDGE TO
ARTIFICIAL INTELLIGENCE.
IT'S TO DEVELOP THESE LARGE
SCALE DATASETS THAT ARE A.I.
READY, AS I MENTIONED, AND THAT
ADDRESS VERY DIFFICULT PROBLEMS
TO SOLVE.
ONE OF THE PROBLEMS THAT THE
BRIDGE2AI CON COURT YUM IS THE
RETURN TO HEALTH AFTER ILLNESS,
THE ANNUAL MEETING WAS HELD A
COUPLE WEEKS AGO IN APRIL, A
LARGE NUMBER OF INVESTIGATORS
WERE THERE, NOT ALL YET BUT IT
WAS A VERY INTERESTING MEETING.
NEXT MEETING WE'RE HOPING ALL
THE INVESTIGATORS WILL BE ABLE
TO COME.
NEXT SLIDE.
THE EMOTIONAL WELL BEING SECOND
ANNUAL MEETING TOOK PLACE IN
MARCH.
A LOT OF THESE INVESTIGATOR
MEETINGS AS I'LL MENTION FOR
SEVERAL OTHERS ARE JUST CLOSED
FOR INVESTIGATORS ONLY.
BUT THIS PARTICULAR ONE IS -- WE
CAN A KEYNOTE SPEAKER DR.
VANDERWEELE, LECTURE ON
FLOURISHING AND EMOTIONAL
WELL-BEING, IT WAS VIDEOCAST IF
YOU WANT TO WATCH, IT'S ON OUR
WEBSITE.
NEXT SLIDE.
WE'RE ALSO VERY HAPPY TO
PARTICIPATE BACK IN MARCH ON A
STATE-OF-THE-ART CONFERENCE AT
THE V.A. HELD BY THE V.A. ON THE
DEVELOPMENT OF MEASURES, WHOLE
PERSON OUTCOMES, AND IT WAS
TITLED MEASURING WHAT MATTERS, A
WONDERFUL CONFERENCE.
WE REALLY DUG REALLY, REALLY
DEEP INTO MEASURES OF
WELL-BEING, MEASURES OF
PATIENT -- HOW INDIVIDUALS VIEW
THEIR OWN HEALTH, AND ALSO WHAT
IS THE RELATIONSHIP BETWEEN
HEALTH AND WELL-BEING.
IT WAS JUST A LOVELY MEETING,
AND DR. EDWARDS AND QUINLAN AND
MYSELF ATTENDED.
THERE'S A LOT OF IMPORTANT
ACTION ITEMS THAT ARE GOING TO
BE DERIVED FROM THIS MEETING.
DR. BEN KLIGLER ON ZOOM IS
LEADING THIS EFFORT AND WE'RE
GRATEFUL FOR THE PARTNERSHIP.
NEXT SLIDE.
I WANT TO NOW HIGHLIGHT ONE OF
OUR HOT TOPIC WEBINARS THAT WAS
ON MARCH -- WE HAD TWO.
ONE ON MARCH 6 AND APRIL 28.
AND THIS WAS -- THEY WERE ON
EXPANDING THE TRANSLATIONALLY
RELEVANT CHEMICAL SPACE,
INSIGHTS INTO NATURAL PRODUCT
RESOURCES, TECHNOLOGIES, AND
MECHANISMS.
THESE ARE VIDEOTAPED SO IF YOU
WANT TO WATCH THEM, THEY ARE
AVAILABLE ON OUR WEBSITE.
NEXT SLIDE PLEASE.
WE HAD AN ARTS AND WELLNESS
PANEL WITHIN THE NEUROARTS
BLUEPRINT APRIL 19, IT WAS
DISCUSSION AT THE KENNEDY CENTER
WITH RENÉE FLEMING, AND DR.
EDWARDS AND DR. FRANCIS COLLINS
PRESENTED THE NIH MUSIC-BASED
INTERVENTION TOOLKIT AT THAT
MEETING.
THERE'S A VIDEO ARCHIVE AGAIN IF
YOU WANT TO WATCH IT.
NEXT SLIDE.
AND NOW I WANT TO HIGHLIGHT
UPCOMING ACTIVITIES.
THE FIRST IS THE FIRST ANNUAL
NOW PURPOSE MEETING FOR EARLY
CAREER PAIN RESEARCHERS WITHIN
THE HEAL INITIATIVE.
THIS HAPPENED JUST YESTERDAY, I
GUESS, IT'S STILL GOING ON.
AND I UNDERSTAND DR. CLARK WAS
PART OF THIS, THIS IS FOR
ENCOURAGING NETWORKING AMONG THE
EARLY-STAGE INVESTIGATORS AND A
LOT OF MENTORING, SO A GREAT
OPPORTUNITY FOR PAIN RESEARCHERS
WITHIN "HEAL."
NEXT SLIDE.
WE'RE GOING TO BE HAVING OUR
WORKSHOP AGAIN SPONSORED BY THE
HEAL INITIATIVE ON UNDERSTANDING
AND RESTORING WHOLE JOINT HEALTH
IN PAIN MANAGEMENT.
THIS IS GOING TO BE JULY 25 AND
26.
IT'S GOING TO BE A VIRTUAL
WORKSHOP, AND REGISTRATION, WE
ENCOURAGE ANY OF YOU WHO ARE
INTERESTED TO REGISTER HERE ON
OUR WEBSITE.
NOW, THIS IS A VERY IMPORTANT
INITIATIVE BECAUSE WHAT WE FEEL
IS, YOU KNOW, JOINT PAIN IS
SOMETHING THAT WHEN PEOPLE HAVE
PAIN IN THEIR JOINTS USUALLY WE
ASSUME THE PAIN IS COMING FROM
THE JOINT, THE ARTICULATION
ITSELF, THE CARTILAGE, RIGHT?
THERE'S A LOT OF OTHER PIECES OF
THE JOINT WHICH WE PAY A LOT
LESS ATTENTION TO, AND THESE
ARE, FOR EXAMPLE, PERIARTICULAR
TISSUES, CAPSULES, MUSCLE ,
LIGAMENTS, FASCIA, ALL THESE
COMPONENTS OF THE JOINT.
SO WHAT WE WANT TO DO IS HAVE
PRESENTATIONS ON BOTH ARTICULAR
AND PERIARTICULAR COMPONENTS OF
JOINT PAIN AS WELL AS DIFFERENT
TYPES OF THERAPEUTIC APPROACHES
THAT MAY ADDRESS THIS.
NEXT SLIDE.
WE WERE GOING TO BE HAVING,
AGAIN, PART OF THE BRAIN
INITIATIVE THIS TIME, THE
SCIENTIFIC MEETING ON JUNE 12
AND 13.
THIS IS ANNUAL MEETING.
AND, AGAIN, OPEN TO -- NOT JUST
FOR INVESTIGATORS.
YOU CAN REGISTER AT THE BRAIN
INITIATIVE WEBSITE.
NEXT IS OUR FOUR SPACE
MANIPULATION MEETING, KEYNOTE
SPEAKER, DR. DAVID GINTE, ALSO
AVAILABLE FOR VIEWING, SO YOU
CAN REGISTER ON THAT.
I'M SORRY, THE BLUE IS NOT VERY
VISIBLE.
AND SO THERE IS GOING TO BE AN
OPEN SESSION, THE REST OF THE
MEETING WILL BE FOR
INVESTIGATORS ONLY, FORCE-BASED
MANIPULATION IS ONE OF OUR
NETWORKS WE'VE BEEN HAVING THAT
IS NOW FUNDED FOR THE SECOND
YEAR, AND WE'RE PLEASED WITH HOW
INVESTIGATORS ARE COMING
TOGETHER AND GROWING THIS FIELD
OF FORCE-BASED MANIPULATION.
AROUND FOUR MEETINGS CLOSED TO
THE PUBLIC BUT THESE
INITIATIVES, PAIN MANAGEMENT
COLLABORATORY, PRAGMATIC, HEAL
RESEARCH TO IMPROVE MEDICATION
BASED TREMENDOUS OR BRIM, AND
BOTANICALS AND NATURAL PRODUCTS
OR CARBON, ALL OF THESE
INITIATIVES, ANNUAL MEETINGS ARE
REALLY IMPORTANT FOR
INVESTIGATORS TO MEET TOGETHER,
EXCHANGE IDEAS, ALSO IT'S
IMPORTANT FOR US AT NCCIH TO
HEAR HOW THEY ARE DOING.
I WANT TO HIGHLIGHT TWO OF OUR
INTEGRATIVE MEDICINE RESEARCH
LECTURE SERIES THAT ARE
UPCOMING.
ONE, THE FIRST ONE ON MAY 25,
AND JUNE 15.
AND THESE ARE REALLY GEARED
TOWARDS CHILDREN AND SORT OF
ADDRESSING PREVENTION EARLY IN
LIFE, VERY IMPORTANT.
FIRST UNLEASHING POWER OF
PREVENTION TO ENHANCE WELL-BEING
ACROSS THE LIFESPAN BY DR.
MARGARET KULINSKI, PREVENTING
PROBLEMS BEFORE THEY BEGIN,
TRACING EVOLUTION OF PREVENTION
SCIENCE, SHARING FINDINGS FROM
LONGITUDINAL INTERVENTION
STUDIES BASED ON SOCIAL
DEVELOPMENT STRATEGY AND SHE
WILL DESCRIBE WHAT IS NEEDED TO
INCREASE EQUITABLE REACH AND
IMPACT OF EFFECTIVE HEALTH
PROMOTION AND PREVENTION
APPROACHES.
OTHER LECTURE, NEXT SLIDE
PLEASE, JUNE 15, DR. TANYA
PALERMO, INSIGHTS INTO
PREVENTION AND MANAGEMENT OF
CHRONIC PAIN IN CHILDREN AND
ADOLESCENTS, FOCUSING ON PAIN.
IT'S ASTONISHING THAT PAIN IS
NOW AFFECTING A HIGH NUMBER OF
CHILDREN, UP TO 40% OF CHILDREN
REPORT PROBLEMS WITH PAIN.
THE RISK OF CONTINUED PAIN AND
IMPACT OF CHILDHOOD PAIN ON
HEALTH AND DEVELOPMENT IN
ADULTHOOD IS A CRISIS.
IT'S AN EMERGENT AREA OF
RESEARCH.
AND PSYCHOLOGICAL INTERVENTIONS
DELIVERED IN CHILDHOOD MAY HELP
PREVENT PAIN AND DISABILITY AND
BUILD RESILIENCE ACROSS THE
LIFESPAN, SO VERY, VERY
IMPORTANT.
SHE WILL ALSO HIGHLIGHT THE ROLE
OF ACCESSIBLE DIGITAL HEALTH IN
PAIN INTERVENTIONS FOR
INCREASING ACCESS AND EQUITY IN
HEALTH CARE FOR PAIN.
NEXT ANOTHER HOT TOPIC WEBINAR
ON JUNE 7, LAUNCHING A CAREER IN
HEALTH DISPARITIES RESEARCH,
FROM THE PERSPECTIVE OF NCCIH.
OUR SPEAKERS WILL BE DR. EUGENE
DUNNE FROM TEMPLE, DR. KRYSTAL
CHAPMAN LAMBERT, AND DR. SHUFANG
SUN FROM BROWN UNIVERSITY,
HIGHLIGHTING THREE NCCIH FUNDED
EARLY CAREER INVESTIGATORS
FOCUSED ON HIV POPULATIONS.
PROVIDING OVERVIEW OF RESEARCH,
PARTICIPATE IN GUIDED DISCUSSION
ABOUT THEIR CAREER PATH,
INCLUDING CHALLENGES OF
CONDUCTING RESEARCH TO ADDRESS
HEALTH DISPARITIES.
WE'RE PARTICIPATING IN NCCIH ON
DR. RICHARD NAHAN PARTICIPATING
IN A WEBINAR, CONTEXT OF HEALTHY
PEOPLE 2030 SPOTLIGHT ON HEALTH,
BEST PRACTICES IN PAIN CARE ON
MAY 23.
YOU CAN REGISTER FOR THIS.
MORE EFFORTS FOR EMOTIONAL
WELL-BEING, NCCIH IS GOING TO BE
PARTICIPATING IN A BRAIN
SYMPOSIUM ON EMOTIONAL
WELL-BEING, CAN WE MEASURE,
MONITOR, MODULATE IT IN THE
BRAIN, IN MAY.
AGAIN, YOU CAN REGISTER FOR
THIS.
I DON'T KNOW IF THIS IS VIRTUAL
OR NOT.
NEXT SLIDE PLEASE.
ANOTHER VERY IMPORTANT SYMPOSIUM
THAT IS GOING TO BE UPCOMING
JUNE 28-29, THIS IS THE 2023
MULTI-SCALE MODELING CONSORTIUM,
IMAG.
VERY, VERY IMPORTANT IN THE
CONTEXT OF DEVELOPING OUR
RESEARCH CAPACITY TO DO WHOLE
PERSON RESEARCH, RIGHT?
THE ABILITY TO DEVELOP, FOR
EXAMPLE, DIGITAL TWINS.
THIS IS KIND OF DEVELOPING
MODELS OF A PERSON THAT REFLECTS
ALL THE TYPES OF DATA THAT CAN
BE GATHERED AND THEN MODELS IN
VIRTUAL WAY, POWERFUL WAY TO DO
MODELING AND TEST INTERVENTION
IN SILICO.
MACHINE LEARNING METHODS, AND
ALSO QUANTUM COMPUTING, VERY
MUCH CUTTING EDGE SYMPOSIUM, AND
THAT THIS IS GOING TO BE AT THE
NATCHER CONFERENCE CENTER AT
NIH.
AND FINALLY, THERE'S GOING TO BE
PRE-CONFERENCE WORKSHOP AT THE
ACADEMY HEALTH ANNUAL RESEARCH
MEETING, GIVEN BY THE PRAGMATIC
TRIALS COLLABORATORY TEAM,
PRESENTED BY DR. WENDY WEBER AND
BEDA JEAN-FRANCOIS, AND THIS IS
A PRE-CONFERENCE WORKSHOP ON
PRAGMATIC TRIAL DESIGN AND
METHODS.
THE MEETING IS AGAIN OPEN FOR
REGISTRATION TO ATTEND.
AND FINALLY, OUR NEXT MEETING
SEPTEMBER 8, SAVE THE DATE
PLEASE.
I HOPE THAT WE'RE GOING TO
SEE -- CONTINUE SEEING AS MANY
OF YOU AS POSSIBLE IN PERSON AT
THIS MEETING IN SEPTEMBER.
SO THANK YOU.
WE HAVE A COUPLE MINUTES IF
THERE ARE QUESTIONS OR COMMENTS
FROM COUNCIL MEMBERS, I WOULD
CERTAINLY WELCOME.
ANY QUESTIONS?
>> CAN I ADD SOMETHING?
>>YEAH.
>> WE FORGOT TO INCLUDE THAT
SLIDE BUT I WANTED TO BRING TO
YOUR ATTENTION THAT THE FINANCED
FROM THE NIH DIRECTORS
HIGH-RISK, HIGH-REWARD PROGRAM,
ALL THE RFAs ARE OUT, THE
RANGE FROM AUGUST 18 THROUGH
SEPTEMBER 8 FOR RECEIPT DATE, SO
PLEASE GO TO THE WEBSITE FOR
HRHR, WE'VE BEEN VERY SUCCESSFUL
IN, YOU KNOW, GETTING SOME GREAT
INVESTIGATORS IN ALL THE
DIFFERENT OPPORTUNITIES THAT ARE
OUT THERE.
TAKE A LOOK AT THAT.
>> GREAT.
THANK YOU.
>> THANK YOU SO MUCH FOR
BRINGING US UP TO DATE ON THESE
REALLY INTRIGUING AND EXCITING
DEVELOPMENTS.
JUST TO KIND OF OVERARCHING
THEMATIC QUESTIONS COMING UP FOR
ME, ACTUALLY A THIRD.
IN SOME SENSE, I'M ALWAYS
CURIOUS ABOUT HOW TO INTEGRATE
ALL OF THESE DIFFERENT DOMAINS
OF INVESTIGATION, RESEARCH
FINDINGS, WAYS THAT MAKE IT EVEN
MORE EASY FOR THE LAY POPULATION
TO IDENTIFY TAKEAWAYS THAT THEY
CAN ACTIONABLY APPLY TO THEIR
LIVES RIGHT NOW.
SO I LOVE THE WIDE AND BROAD
DIVERSITY IN REACH AND SCOPE AND
GENUINELY AM APPRECIATIVE, ALSO
THINKING ARE THERE WAYS TO TELL
A STORY TO THE PUBLIC ABOUT ALL
OF THIS THAT HELPS MAKE PLAIN
MAJOR VERSUS SUBSIDIARY KINDS OF
FINDINGS AND KEEPS US FEELING
LIKE WE'RE MOVING ALONG,
EXPANDING THE BROADLY ACCESSIBLE
CONVERSATIONS ABOUT HEALTH SPAN
DURING THESE TIMES, NEW WAYS OF
ACCESSING THEM, SUPPORTING THAT
ACROSS ALL COMMUNITIES SO WE ALL
FLOURISH TOGETHER.
AND THAT AND I GUESS THE OTHER
TWO POINTS RELATED TO THAT
OVERARCHING INQUIRY ABOUT HOW DO
WE TELL THAT STORY, HOW DO WE
CONVEY THESE EXCITING
DEVELOPMENTS IN WAYS THAT MAKE
IT ALL THE MORE EASILY
ACCESSIBLE FOR LAY POPULATIONS
TO SEE THE BROAD OUTLINES AND
BUSY SCHEDULE WHEN THEY ARE NOT
GOING INTO THE WEEDS BUT TO BE
ABLE TO TAKE, LIKE, WHERE ARE WE
WITH HEALTH AND WHAT ARE THE
WONDERFULLY EXCITING ASPECTS
THAT WE'RE MOVING INTO IN THESE
NEW TIMES WITH NEW TECHNOLOGICAL
RESOURCES, ET CETERA, AND WHERE
ARE THE CHALLENGES.
JUST TO BE ABLE TO TAKE THAT UP.
IT'S ALL THERE.
JUST TO SAY THAT.
AND THEN RELATEDLY, I'M ALWAYS
THINKING ABOUT THE EFFECTS OF
ECONOMIC INEQUALITY ON HEALTH
AND WELL-BEING, AND WHO GETS TO
BE WELL.
AND JUST CURIOUS ABOUT HOW,
AGAIN, THE VARIOUS DIFFERENT
PROGRAMS AND POINTS OF FOCUS
KEEP US LOOKING AT EVER MORE
UNION SORT OF CONCERNING FOR US
PATTERNS AROUND ECONOMIC
EQUALITY, LEADING TO THE SECOND
PIECE, MAYBE THIRD, WHICH IS
ABOUT A.I. AND ITS IMPLICATIONS.
YOU KNOW, SO THE ETHICS OF
HEALTH AND WELL-BEING AND A.I.,
WE'RE SO EXCITED ABOUT
POSSIBILITIES AND POTENTIAL FOR
ALL THINGS THAT CAN DEVELOP
AROUND A.I. FOR HEALTH AND
WELL-BEING, THINK ALL OF US ARE.
AND I'M ALSO AWARE OF CONCERNS
ABOUT, YOU KNOW, ETHICAL
FRAMEWORKS NECESSARY TO MOVE US
ALL AGAIN POSITIVELY FORWARD IN
A WAY WE CAN ALL FLOURISH
TOGETHER.
THAT INTERLINKS I THINK, THESE
QUESTIONS ABOUT THE
ACCESSIBILITY OF THE INFORMATION
FOR ALL OF US, TRANSLATING INTO
WAYS INFORMATION IS ACCESSIBLE
FOR EVERYBODY.
THE PATTERNS OF EXACERBATED
INEQUALITY AND ITS EFFECTS, AND
THEN OF COURSE THE ETHICS AROUND
A.I. AS A COMPONENT OF ALL OF
THAT.
BIG PICTURE THINGS THAT JUST
WANT TO PUT ON THE TABLE AS WE
THINK ABOUT THE BEAUTIFUL WORK
THAT YOU SHARED WITH US TODAY.
>> WELL, THANK YOU.
I COULD PERHAPS RESPOND VERY
BRIEFLY TO GIVE OTHER PEOPLE A
CHANCE TO COMMENT IF THEY HAVE.
BUT COMMUNICATION IS SOMETHING
WE TAKE SERIOUSLY AT NCCIH, WE
HAVE AN ACTIVE COMMUNICATIONS,
THE DIRECTOR IS HERE, KATHERINE
LAW.
WE TAKE GREAT PRIDE IN HOW WE
PRESENT INFORMATION ON OUR
WEBSITE SO IT'S ACCESSIBLE TO
RESEARCHERS AND THE PUBLIC.
IN TERMS OF PACKAGING OUR
FINDINGS INTO KIND OF INTEGRATED
BODY OF KNOWLEDGE, I THINK
THAT'S WHAT YOU WERE HINTING AT
IN YOUR FIRST PART OF THE
QUESTION.
YEAH, HOW DO YOU MAKE SENSE OF
ALL OF THIS AND INTEGRATE?
AND THIS IS A BIG PIECE OF WHAT
WE WANT TO DO WITH WHOLE PERSON
HEALTH.
BECAUSE BEFORE IN PREVIOUS TIMES
NCCIH WAS LOOKING AT DIFFERENT
MODALITIES SEPARATELY.
YOU HAD NATURAL PRODUCTS, MIND
AND BODY THERAPIES, ACUPUNCTURE,
BUT NOW WE'RE REALLY TRYING TO
MAKE THIS AND PUT THIS INTO AN
INTEGRATED FRAMEWORK SO
HOPEFULLY THAT WILL HELP.
WE'VE HAD A TREMENDOUS RESPONSE
FROM THE COMMUNITY ABOUT THIS.
WE HAD A STAKEHOLDER MEETING
LAST FALL WITH, YOU KNOW, OVER
100 ORGANIZATIONS REPRESENTED
AND FROM ALL DIFFERENT KINDS OF
AREAS.
AND SO PEOPLE RESONATE WITH THIS
MESSAGE VERY, VERY MUCH.
THE SECOND THING YOU'RE TALKING
ABOUT IN TERMS OF A.I., YES, AND
YES, YES, AND YES.
ONE OF THE IMPORTANT --
BRIDGE2AI INITIATIVE, I'M ONE OF
THE FIVE INSTITUTE DIRECTORS ON
THE EXECUTIVE COMMITTEE, ONE OF
THE PRIMARY CONCERNS IS TO BUILD
AN EXAMPLE HOW TO BUILD
A.I.-READY DATASET THAT IS
ETHICALLY SOUND, THAT PAYS
ATTENTION TO REALLY MAKING SURE
THERE ARE NO BUILT-IN INEQUITIES
IN THE ACQUISITION OF THE DATA,
THAT'S EASIER SAID THAN DONE,
OBVIOUSLY.
THERE'S A WHOLE ETHICS CORE THAT
IS REALLY DESIGNED TO LOOKING AT
THIS.
YES, VERY GOOD QUESTIONS.
THANK YOU.
DR. JEAN-LOUIS?
>> THANK YOU FOR A WONDERFUL
PRESENTATION.
I LIKE THE IDEA OF INTRODUCING
QUANTUM COMPUTING TO ACCELERATE
DISCOVERIES.
NOW, SUCH EQUIPMENT CAN BE VERY
EXPENSIVE, WOULD NIH BE WILLING
TO SUPPORT PROJECTS THAT ARE
ASKING FUNDING TO BUILD SUCH
PROGRAMS?
>> WELL, YOU KNOW, WE ARE -- I
CANNOT ANSWER THIS QUESTION
DIRECTLY BECAUSE THIS IS A
VERY -- OBVIOUSLY A SPECIFIC
REQUEST IN REGARDS TO EQUIPMENT
AND STUFF LIKE THAT, HAVE TO BE
DONE ON A CASE-BY-CASE BASIS.
HOWEVER, WHAT I CAN SAY IS THAT
NIH AS A WHOLE, WE HAVE NOW OUR
OFFICE OF DATA STRATEGY THAT IS
HEAVILY INVESTED IN MAKING SURE
THAT INVESTIGATORS HAVE THE
TOOLS AND RESOURCES AVAILABLE TO
GET -- TO MOVE INTO THIS SORT OF
NEW ERA OF BIG DATA.
HOW ARE WE GOING TO DO THIS?
THERE'S SO MANY LAYERS TO THIS.
YOU'RE POINTING OUT THAT
EQUIPMENT, RIGHT, THAT'S
IMPORTANT, BUT ALSO DATA STORAGE
AND DATA STORAGE OVER THE LONGER
TERM, THAT'S ALSO VERY
EXPENSIVE.
HOW ARE WE GOING TO DO THIS?
SO THERE ARE -- WE'RE ENGAGED IN
DEEP CONVERSATIONS THROUGHOUT
NIH, INCLUDING LED BY ODSS AND
NATIONAL LIBRARY OF MEDICINE,
NLM IS VERY MUCH ENGAGED IN
THIS, MAKING SURE THAT WE ARE
MOVING FORWARD WITH THIS AS
QUICKLY AND BEST AS WE CAN.
EXCELLENT QUESTION.
YOU KNOW, WE'LL HAVE TO SEE WHAT
HAPPENS WITH THIS.
EVERYTHING IS SUBJECT TO
AVAILABILITY OF FUNDS,
OBVIOUSLY, RIGHT?
IT'S AN IMPORTANT PIECE, AS YOU
SAY.
THIS IS EXPENSIVE TO DO.
AND SO WE NEED TO LOOK AT ALL
THE ASPECTS OF THAT.
YEAH, VERY GOOD QUESTION.
>> THANK YOU.
>> ANY OTHER QUESTIONS?
PARDON?
>> OH, YES.
>> IT'S NOT A QUESTION, JUST A
COMMENT GOING BACK TO YOUR
MENTION OF THE CONFERENCE AT
V.A. ON MEASURING WHAT MATTERS
MOST.
I WANTED TO SHARE HOW GRATEFUL
WE ARE WITH THE NCCIH MEASURING
OUTCOMES THAT REFLECT WHOLE
PERSON HEALTH AND HOW CRITICAL,
WE THINK THAT IS FOR MOVING THE
ENDEAVOR FORWARD BUT ALSO HOW
MUCH THAT'S AN INTEREST THAT'S
SPANNING ACROSS DIFFERENT
GOVERNMENT AGENCIES, NOT JUST
NIH AND V.A., BUT HEALTH AND
HUMAN SERVICES, AND CMS, AND
SURGEON GENERAL'S OFFICE, AND
JUST SO MANY AGENCIES THAT ARE
NOW ENGAGED AROUND THIS QUESTION
OF HOW DO WE GET BEYOND
DISEASE-SPECIFIC OR
PROBLEM-SPECIFIC OUTCOME
MEASUREMENTS TO LOOK HARDER AT
THINGS THAT CAPTURE WHAT'S
IMPORTANT AT THE WHOLE PERSON.
I WANT TO THANK YOU FOR YOUR
PARTNERSHIP.
I THINK WE'RE GOING TO SEE SOME
REALLY AMAZING MOVEMENT IN THAT
AREA OVER THE NEXT COUPLE YEARS.
AND THE WAY YOU ARE PUSHING THAT
FORWARD AT NIH IN THE
CONVERSATION IS REALLY A HUGE
PART OF THAT.
SO I WANTED TO THANK YOU FOR
THAT AND SHARE WITH PEOPLE WHO
ARE LISTENING AND WATCH FLAG IF
YOU -- WATCHING THAT IF YOU
WASN'T ENGAGED, IT'S SPREADING
QUICKLY ACROSS A LOT OF ACADEMIC
HEALTH ENVIRONMENTS AS WELL AS
GOVERNMENT.
THANK YOU, DR. LANGEVIN, FOR
HELPING WITH THAT.
I REALLY APPRECIATE IT.
>> WELL, THANK YOU.
WE'RE SO -- BY THE WAY, ARE
YOU -- THE PROGRAM CAMERA IS NOT
ON?
IT IS ON?
I DON'T SEE IT.
>> IT'S BEING CAPTURED --
(INAUDIBLE).
>> I GUESS IT'S THE PEOPLE ON
ZOOM THAT CAN'T SEE IT.
ANYWAY, DOESN'T MATTER.
EXCUSE ME.
WE'RE SO GRATEFUL WITH THIS --
IT GOES BOTH WAYS.
WHAT DR. KLIGLER DESCRIBED IS AN
AMAZING PARTNERSHIP PUSHING
FORWARD, AND AT THE V.A. THEY
ARE DEMONSTRATING THAT A WHOLE
HEALTH APPROACH IS NOT ONLY
FEASIBLE, IMPLEMENTABLE, ALSO
SUCCESSFUL.
SO, WE ARE REALLY KIND OF --
WE'RE DEVELOPING THIS KIND OF IN
PARALLEL BUT THERE'S SO MANY
CONNECTIONS BETWEEN THE TWO THAT
WE'RE VERY, VERY HAPPY WITH THIS
AS WELL.
SO THANK YOU.
I SEE SOME COUNCIL MEMBERS
APPEARING.
THAT'S WONDERFUL.
BECAUSE THE NEXT STEP -- ANY
OTHER COMMENTS BEFORE I MOVE
OVER TO THE NEXT STAGE?
MY NEXT JOB IS TO THANK RETIRING
COUNCIL MEMBERS.
IT'S ALWAYS BITTERSWEET.
I WANT TO MAKE SURE I HAVE THE
RIGHT -- OKAY.
WE HAVE A FEW MEMBERS WHO ARE ON
ZOOM AND SOME WHO ARE NOT.
PEOPLE WHO ARE ON ZOOM, I'M
GOING TO THANK AND GIVE YOU YOUR
CERTIFICATE VIRTUALLY.
DR. DIANA FISHBEIN, WE'RE GOING
TO MISS YOU SO VERY MUCH.
AND WE WANT TO THANK YOU SO MUCH
FOR YOUR SERVICE ON THE COUNCIL
AND WE REALLY WISH YOU ALL THE
BEST.
I'M HANDING YOU OVER YOUR
CERTIFICATE AND I WANT TO THANK
YOU.
NEXT IS DR. RICK HARRIS.
WHERE IS RICK?
RICK?
SO, THANK YOU SO VERY MUCH FOR
SERVING ON THE COUNCIL.
I THINK WE EXTENDED YOUR TERM
FOR AS LONG AS WE POSSIBLY
COULD.
AND REALLY WANT TO THANK YOU AND
WE SO MUCH LOOK FORWARD TO
CONTINUING TO WORK WITH YOU IN
DIFFERENT CAPACITIES, BUT HERE
IS YOUR CERTIFICATE.
>> THANK YOU.
THANK YOU SO MUCH.
>> THANK YOU.
AND FINALLY DR. TAMMY BORZINGA,
-- HUIZENGA.
>> THANK YOU.
>> AND NOT ATTENDING, DR. RONI
EVANS, DR. KINSEL, AND DR.
JUSTIN SUNBERG.
WE WANT TO THANK ALL OF THEM.
ALL RIGHT.
>> GOOD AFTERNOON, EVERYONE.
SO, I HAVE THE PLEASURE OF
TRYING TO EXPLAIN TO YOU WHAT IS
THE HEAL INITIATIVE, HELPING
ENDS ADDICTION LONG TERM.
AND SO WE HAVE A PANEL OF
SPEAKERS, WE'RE GOING TO TALK
ABOUT WHAT REALLY NCCIH IS DOING
IN RELATION TO THE HEAL
INITIATIVE, AND REALLY FOCUS
TODAY MORE ON THE CLINICAL
RESEARCH ACTIVITIES AND IN
FUTURE MEETING WE'LL TALK MORE
ABOUT THE BASIC AND MECHANISTIC
RESEARCH THAT'S SUPPORTED BY THE
HEAL INITIATIVE.
THE SLIDE DR. LANGEVIN PRESENTED
EARLIER SET WE UP WHERE YOU CAN
SEE HOW MUCH OF THE HEAL FUNDS
ARE COMING TOWARDS NCCIH.
I'M ALSO GOING TO HIGHLIGHT SOME
EXAMPLES WHERE WE MAY NOT BE
ADMINISTERING THE AWARD BUT MANY
OF THE TOPICS AND PROJECTS THAT
ARE ONGOING REALLY RELATE QUITE
CLOSELY TO OUR MISSION AND OUR
VISION.
SO WE'VE BEEN EXCITED TO BE PART
OF THE HEAL INITIATIVE, AND I'LL
GIVE YOU A LITTLE BIT OF
OVERVIEW HERE.
I'M FIRST GOING TO START OFF
WITH TELLING YOU, I'LL HAVE TO
ASK YOU TO DO NEXT SLIDE BECAUSE
IT BUZZED AT ME FOR CLICKING THE
NEXT BUTTON.
CAN YOU GUYS ADVANCE FOR ME?
THANK YOU.
SO WE'RE GOING TO HAVE FOUR
SPEAKERS, I'M THE FIRST, AN
OVERVIEW OF THE STRUCTURE OF
"HEAL," TALK ABOUT SOME OF THE
PAIN CLINICAL RESEARCH PROJECTS
AND PROGRAMS THAT ARE PART OF
THE PROGRAM AND RELEVANT TO OUR
MISSION HERE AT NCCIH.
AND THEN I'M GOING TO TURN
THINGS OVER TO DR. PETER MURRAY,
WHO IS ONE OF OUR PROGRAM
OFFICERS IN THE CLINICAL
RESEARCH BRANCH, HE'S GOING TO
TALK ABOUT SOME OF THE PROJECTS
THAT WE'RE OVERSEEING AND
PROGRAMS RELATED TO OPIOID USE
DISORDER AND HE WILL TELL YOU
ABOUT THOSE AS WELL AS REALLY
EXCITING NEW TRAINING
OPPORTUNITIES THAT ARE COMING UP
WITHIN THE HEAL INITIATIVE.
AND THEN WE HAVE TWO SPEAKERS
THAT ARE DOING "HEAL"-FUNDED
RESEARCH, JOINING US VIRTUALLY
BOTH ONLINE, THANK YOU DR.
MORONE AND DR. COOPERMAN.
I'LL GIVE YOU INTROS AND THEY
WILL COME UP LATER WHEN THEY
TALK ABOUT THEIR WORK.
DR. MORONE IS ASSOCIATE
PROFESSOR OF MEDICINE BOSTON
UNIVERSITY, BOSTON MEDICAL
CENTER.
RESEARCH CAREER IS FOCUSED ON
INTEGRATIVE NON-PHARMACOLOGIC
INTERVENTION TO TREAT CHRONIC
PAIN, CONDUCTED SEVERAL LARGE
TRIALS, WILL TELL YOU ABOUT ONE
OF THEM LATER TODAY BUT SHE'S
ALSO VERY INTERESTED IN CAREER
DEVELOPMENT PROGRAMS ESPECIALLY
THOSE THAT ASSIST
UNDERREPRESENTED GROUPS IN
HELPING THEM STAY IN THE
RESEARCH PIPELINE AND PURSUE
CAREERS IN RESEARCH.
AND WE'LL WRAP UP WITH DR. NINA
COOPERMAN, WHO IS ASSOCIATE
PROFESSOR IN DIVISION OF
ADDICTION PSYCHIATRY AT RUTGERS
MEDICAL SCHOOL.
SHE'S THE CHAIR FOR THE
TREATMENT AND RECOVERY PROGRAM
AT THE RUTGERS ADDICTION
RESEARCH CENTER.
SHE'S CLINICAL PSYCHOLOGIST
THAT'S BEEN STUDYING BEHAVIORAL
INTERVENTIONS AMONG INDIVIDUALS
WITH SUBSTANCE USE DISORDERS FOR
OVER 20 YEARS, SHE'S GOING TO
TELL US ABOUT THE MINDFULNESS
ORIENTED RECOVERY ENHANCEMENT
PROGRAM, THE MORE PROGRAM, WHAT
SHE'S FUNDED IN "HEAL" TO DO.
LET'S JUMP IN AND LET ME GIVE
YOU OVERSIGHT INTO THE "HEAL"
PROGRAM.
NEXT SLIDE.
SO, THIS ALL STARTED IN 2018
WITH APPROPRIATION FROM CONGRESS
TO ADDRESS OPIOID AND THE PAIN
CRISIS IN THE U.S.
THERE'S TWO OVERARCHING GOALS TO
ENHANCE PAIN MANAGEMENT TO
REDUCE THE RISK AND NEED FOR
STARTING OPIOIDS IN PATIENTS WHO
HAVE PAIN.
AND THE OTHER KEY ELEMENT HERE
IS TO IMPROVE PREVENTION AND
TREATMENT STRATEGIES FOR OPIOID
ADDICTION AND OVERDOSE.
THIS CONTINUES TO EVOLVE OVER
TIME.
NOW FIVE YEARS INTO THE PROGRAM,
WE'VE DONE A LOT.
IT'S BEEN QUITE EXCITING TO SEE
WHAT ALL WE'VE DONE.
NEXT SLIDE.
SO, JUST A COUPLE VERY BRIEF
SLIDES JUST TO PUT EVERYBODY ON
THE SAME PAGE IN TERMS OF
CONTEXT.
1980s WE SEE VICODIN,
CONSIDERED SAFE.
1990s, LONGER ACTING,
OXYCONTIN, PAIN BECOMING THE
FIFTH VITAL SIGN, THE HUGE
INCREASE IN USE OF THESE PAIN
MEDICATIONS AND THEIR MARKETING
AND BELIEVING THEY REALLY
WOULDN'T CAUSE ADDICTION IN
PEOPLE WITH PAIN.
WE'VE NOW OF COURSE LEARNED THAT
IT DOES CAUSE ADDICTION IN
PEOPLE EVEN IF THEY DO HAVE
PAIN, IT IS YET STILL A VERY
IMPORTANT THERAPEUTIC AND HAS AN
IMPORTANT USE WHEN IT IS
INDICATED, AND WHAT WE WANT TO
DO IS MAKE SURE IT'S USED
APPROPRIATELY TO MANAGE THOSE
SITUATIONS, AND THAT WE DON'T
GET INTO THE SITUATION WHERE
PEOPLE HAVE ACTUAL ADDICTION AND
IT REALLY TAKES OVER THEIR
LIVES.
WHAT WE'VE SEEN IS THE SHIFT
FROM PEOPLE USING THESE
PRESCRIPTION MEDICATIONS TO
USING INITIALLY HEROIN BUT NOW
WE'RE SEEING FENTANYL IS THE
MAJOR THING THAT'S BEING USED.
AND THAT LITTLE VIAL SHOWS YOU
LETHAL DOSE OF FENTANYL AND HOW
SMALL THAT AMOUNT IS, WHICH IS
WHY WE HAVE SO MANY MORE
OVERDOSES AND THE ISSUES WITH
CONTAMINATION THAT WE'RE SEEING
ACROSS ALL FAKE PILLS BEING SOLD
ONLINE AND ALL KINDS OF
DIFFERENT PLACES THAT YOU CAN
GET THESE THINGS.
THE NUMBERS ARE STAGGERING.
THEY CONTINUE TO RISE.
NOW WE'RE SEEING MORE AND MORE
ISSUES WITH POLY SUBSTANCE USE,
AND OVERDOSE EPIDEMIC.
UNFORTUNATELY MOVING INTO
YOUNGER ADOLESCENTS WITH KIDS
TAKING A FAKE ADDERALL, FOR
EXAMPLE, LACED OR CONTAMINATED
WITH FENTANYL AND DYING.
THERE'S JUST REALLY TRAGIC
STORIES.
NEXT SLIDE.
SO WHEN YOU LOOK AT ALL OVERDOSE
DEATHS OVER TIME, THIS STARTS IN
2015 AND GOES TO 2022, ALMOST
90% OF OPIOID OVERDOSE DEATHS
ARE OVERDOSES IN GENERAL LINKED
TO OPIOIDS.
AND ALMOST ALL OF THAT IS
SYNTHETIC OPIOIDS, BROWN LINE,
THE BLACK LINE IS ALL OPIOIDS
COMBINED.
NEXT SLIDE.
THIS GIVES AN IDEA WHERE WE WERE
IN 2012 IN TERMS OF NUMBER OF
PRESCRIPTIONS FOR OPIOIDS.
AND THIS REALLY SHOWS THE
PICTURE THAT WE'VE STOPPED MUCH
OF THE PRESCRIBING, THE PROBLEM
NOW IS REALLY THIS ILLICIT
AVAILABILITY AND CONTAMINATION
ISSUE WITH THESE COMPOUNDS, JUST
FLOODING THE MARKET IN OTHER
WAYS.
AND SO THE GRAPH IN 2012 WITH
NUMBER OF PRESCRIPTIONS, THE
DARK COLOR BEING OVER 100
PRESCRIPTIONS PER 100 PERSONS,
WHICH IS PRETTY AMAZING.
AND THEN HOW IT'S REALLY
SHIFTED.
AND THE OTHER THING I THINK
THAT'S AMAZING IS THE LEVEL OF
DETAIL THAT WE HAVE NOW IS SO
MUCH MORE PRECISE IN BEING ABLE
TO SEE EXACTLY WHERE ARE THESE
PROBLEMS, AT THE COUNTY LEVEL
AND SOMETIMES SMALLER AS OPPOSED
TO STATE LEVEL WHEN WE STARTED
MONITORING IN 2012.
NEXT SLIDE.
SO, THE HEAL INITIATIVE IS
LOOKING AT OVERDOSE ISSUES BUT
ALSO LOOKING AT PAIN.
AND SO CHRONIC PAIN STILL
REMAINS AN ENORMOUS PROBLEM IN
THE U.S.
THE NUMBERS HERE THAT YOU SEE
HAVE CONTINUED TO INCREASE FROM
2011, AROUND 18% OF POPULATION
WAS IDENTIFIED HAVING CHRONIC
PAIN DEFINED AS PAIN EXPERIENCED
ON MOST DAYS IN THE LAST THREE
MONTHS WHICH HAS GONE UP TO 20%
IN 2019.
AGAIN WE SEE INCREASES IN HIGH
INTENSITY CHRONIC PAIN WHICH IS
IDENTIFIED WHEN THAT PAIN
INTERFERES WITH AT LEAST ONE
ELEMENT OF SOMEONE'S LIFE GOING
FROM I THINK AROUND 5% TO 7 1/2%
FROM 2011 TO 2019.
SO THIS IS NOT GETTING BETTER.
IT'S SOMETHING WE STILL
OBVIOUSLY NEED ADDRESS AND NEED
TO FIND BETTER TREATMENTS FOR.
NEXT SLIDE.
SO, WHERE ARE WE IN 2023 WITH
THE HEAL INITIATIVE?
SINCE 2018 OVER $2.5 BILLION
HAVE BEEN AWARDED IN RESEARCH
PROJECTS AS PART OF THIS
PROGRAM.
OVER A THOUSAND RESEARCH
PROJECTS WITH 42 SPECIFIC
PROGRAMS AND PROJECTS ACROSS
EVERY STATE IN THE U.S.
THERE ARE 314 CLINICAL TRIALS
UNDERWAY ON ADDICTION SIDE,
OVERDOSE PREVENTION SIDE AS WELL
AS PAIN SIDE.
YOU CAN SEE WE HAVE OVER 100
PROJECTS ON BACK PAIN ALONE.
OVER 200 PROJECTS ADDRESSING
MEDICATIONS FOR OPIOID USE
DISORDER.
THE EXCITING THING IS THAT WE'RE
SEEING NEW COMPOUNDS MOVING
THROUGH THIS PROGRAM, 41 FDA
SUBMISSIONS FOR CLINICAL TESTING
OF NEW DRUGS OR DEVICES, THINGS
ARE MOVING THROUGH THE PIPELINE,
WE'RE STARTING TO SEE THINGS,
YOU'LL GET A TREAT TODAY, YOU'LL
HEAR PREVIEW OF SOME RESULTS OF
ONE OF THE TRIALS THAT'S
ACTUALLY BEEN COMPLETED AS ONE
OF THE EARLY STUDIES AS PART OF
THE PROGRAM.
NEXT SLIDE.
SO, WE TALK A LOT NOW WITHIN THE
"HEAL" PROGRAM ABOUT SORT OF THE
CROSS-CUTTING NATURE OF MANY
PROGRAMS, AND IN TRYING TO WORK
ACROSS EVEN BOTH OUD AND PAIN
SIDE TOGETHER, BECAUSE MANY
PATIENTS WHO HAVE PAIN MAY BE AT
RISK FOR OPIOID USE DISORDER OR
OTHER ADDICTION ISSUES AS WELL
AS PEOPLE WITH SUBSTANCE USE
DISORDERS OFTEN HAVE CHRONIC
PAIN CONDITIONS.
AND SO LOOKING AT THAT OVERLAP
IS SOMETHING WE'RE SEEING A LOT.
YOU'RE STARTING TO SEE DR.
LANGEVIN'S LANGUAGE, MANY
PLACES, SEE IT HERE ON THE FOCUS
ON WHOLE PERSON PATIENT OR
PERSON-CENTRIC RESEARCH LOOKING
AT HEALTH SYSTEM CHALLENGES,
LOOKING AT INEQUITIES, WE HAVE
SOME EXCITING PROGRAMS LAUNCHING
IN THAT AREA.
A BIG FAMILY SIS IN THE PROGRAM
IS DOING A LOT OF COMMUNITY
ENGAGEMENT, PATIENT ENGAGEMENT.
THEY HAVE A COMMUNITY ENGAGEMENT
GROUP THEY WORK WITH AND THAT
PROVIDES FEEDBACK TO "HEAL" AND
WHICH DIRECTIONS IT SHOULD GO.
BUT IT'S STILL -- WE'RE STILL
NIH, STILL RESEARCH FOCUSED,
LOOKING AT BIOLOGY OF PAIN AND
MECHANISMS, IDENTIFYING TARGETS,
THERAPEUTIC TARGETS FOR
TREATMENT.
NEXT SLIDE.
SO, THIS IS THE GRAPHIC THAT DR.
KOROSHETZ SHOWS FOR LIKE ALMOST
EVERYTHING THAT WE'RE DOING ON
THE PAIN SIDE WITHIN "HEAL."
I'M FOCUSING ON MORE OF THE
RIGHT SIDE OF THE SLIDE TODAY,
AS I SAID IN FUTURE MEN
PRESENTATION YOU'LL HEAR ABOUT
THE LEFT SIDE, BASIC AND
MECHANISTIC SIDE.
WE'VE BEEN ABLE TO FILL IN GAPS
AND FILL IN AREAS RELATED TO
PAIN RESEARCH AND IMPROVING
ENHANCEMENT OR ENHANCED PAIN
MANAGEMENT.
SO ON THE FAR RIGHT SIDE,
TOWARDS THE BOTTOM, WE'LL TALK
ABOUT SEVERAL PROGRAMS, I'LL
DEFINE THE ACRONYMS, ERN
PROGRAM, PRISM PROGRAM, HEALTH
EQUITIES PROGRAM, AND PETE IS
GOING TO COVER IMPOWR, AND WE
HAVE A LOT OF RESEARCH IN OUR
PAIN PORTFOLIO THAT IS WHY WE'RE
FOCUSED ON MANY OF THOSE.
NEXT SLIDE.
PRISM, PRAGMATIC AND
IMPLEMENTATION STUDIES FOR
MANAGEMENT OF PAIN TO REDUCE
OPIOID PRESCRIBING.
SO PRISM IS OUR SHORT HAND FOR
THAT.
NEXT SLIDE.
THE GOAL HERE WAS TO -- HOW DO
WE TAKE EVIDENCE-BASED
INTERVENTIONS THAT WE KNOW WORK
FOR PAIN CONDITIONS AND ACTUALLY
GET THEM INTO THE HEALTH CARE
SETTING.
NCCIH PROPOSED THIS TOPIC, AND
DAVID AND I WORKED HARD IN 2018
AND 2019 TO PUSH THIS TOPIC
THROUGH THE "HEAL" LEADERSHIP
AND MAKE THIS ONE HAPPEN.
WE LEVERAGED AN ONGOING PROGRAM
YOU HEARD ABOUT, PRAGMATIC
TRIALS COLLABORATORY, PREVIOUSLY
HEALTH CARE SYSTEMS RESEARCH
COLLABORATORY FIGURING OUT HOW
DO YOU EMBED CLINICAL RESEARCH
INTO THE HEALTH CARE SETTING AND
GET THESE INTERVENTIONS INTO THE
CLINICAL, WHERE PATIENTS ARE AND
HAVE PATIENTS RECEIVING THEIR
REGULAR HEALTH CARE HAVE ACCESS
TO THESE INTERVENTIONS.
AND SO THE GOAL HERE IS DOING
LARGE SCALE FULLY POWERED TRIALS
OR STUDIES TO IMPROVE PAIN
MANAGEMENT.
AS I SAID, REALLY EMBEDDING THIS
INTO THAT REAL WORLD SETTING.
NEXT SLIDE.
SO WE HAVE A COORDINATING CENTER
THAT HELPS SUPPORT THE PROJECTS
AND THEY GO THROUGH THIS PHASED
AWARD MECHANISM, CALLED A
UG3/UH3, ONE YEAR OF PLANNING,
FOUR YEARS TO CONDUCT THE TRIAL.
IN THAT PLANNING PHASE THEY WORK
WITH THIS COORDINATING CENTER,
I'LL SHOW YOU A COUPLE EXAMPLES
OF SOME WORK GROUPS THEY WORK
WITH THAT REALLY HELP THEM MAKE
SURE THEY ARE READY TO GO AND
LAUNCH ONCE THEY GET TO THE
LAUNCH PHASE.
THIS PROGRAM DOES NOT PROVIDE
DATA COORDINATION SUPPORT, MOST
OF THE DATA COMES FROM THE
ELECTRONIC HEALTH RECORDS.
AND WE COULDN'T FIGURE OUT HOW
TO HAVE A DATA COORDINATING
CENTER HAVE AC LESS TO
ELECTRONIC HEALTH RECORDS SO WE
KEPT THAT IN THE HEALTH CARE
SYSTEMS AND EACH PROGRAM HAS
THEIR DATA COORDINATION
ACTIVITIES.
NEXT SLIDE.
SO WE HAVE THIS SET OF PROJECTS
THAT WORK WITH DIFFERENT CORE
WORKING GROUPS, PARTICIPATE IN
STEERING COMMITTEE MEETINGS,
TELECONFERENCES, PARTNERING
ORGANIZATIONS, BUT COORDINATING
CENTER TAKES THOSE LESSONS AND
WHAT THEY ARE LEARNING ACROSS
THE PROJECTS, THEY HAVE A LIVING
TEXT BOOK OF PRAGMATIC RESEARCH
IN HEALTH CARE SYSTEMS, DO A
WEEKLY GRAND ROUNDS WHICH THEY
HAVE BEEN DOING FOR TEN YEARS
NOW AND SO THEY ARE ARCHIVED,
HUNDREDS OF GRAND ROUNDS ARE
AVAILABLE, ANYONE CAN SIGN UP TO
LISTEN TO THOSE.
AND THEY HAVE PUBLISHED JUST
EXTENSIVELY, GUIDANCE DOCUMENTS,
WHITE PAPERS, BEST PRACTICES,
ALL OF THAT INFORMATION TO GET
THIS INFORMATION TO OTHERS WHO
WANT TO DO THIS KIND OF
RESEARCH.
NEXT SLIDE.
EACH OF THE PROJECTS GET SUPPORT
FROM BIOSTATISTICS AND STUDY
DESIGNS , A TEAM LOOKS AT EVERY
PLAN TO TWEAK AND INCREASE
POWER, USE NEW NOVEL METHOD OR
SOMETHING, AND THE GROUP CREATED
NEW METHODS AND VALIDATED NEW
STATISTICAL METHODS FOR
RANDOMIZATION AND OTHER THINGS.
I MENTIONED THEY USE ELECTRONIC
HEALTH RECORDS, THAT'S NOT
ALWAYS EASY.
WE HAVE TECHNICAL SUPPORT FOR
THAT AS WELL AS HOW TO KEEP
INTERACTION WAS YOUR HEALTH CARE
SYSTEMS.
ETHICS AND REGULATORY ISSUES ARE
INTERESTING, OFTEN CLUSTER
RANDOMIZED STUDIES, AND MANY OF
THOSE CASES THEY DON'T GET
CONSENT AND HOW DO THEY DOCUMENT
THAT THEY DON'T NEED THAT, WORK
THROUGH THEIR IRB AND
COORDINATING CENTER PROVIDES
SUPPORT FOR THAT.
NEXT SLIDE.
SO THESE ARE SIX TRIALS
SUPPORTED THROUGH THE PRISM
PROGRAM AT THIS POINT.
WE'RE HOPING FOR ANOTHER SUITE
OF THEM TO BE FUNDED LATER THIS
SUMMER, SO WE'LL HAVE MORE.
YOU'RE GOING TO HEAR FROM DR.
MORONE ABOUT THE OPTIMUM STUDY
TREATMENT OF LOW BACK PAIN USING
VIRTUAL GROUP DELIVERED
MINDFULNESS BASED STRESS
REDUCTION PROGRAM THAT IS IN
PRIMARY CARE AND SET UP AS A
GROUP MEDICAL VISIT.
SO THERE'S A WAY TO BILL
INSURANCE AND ACTUALLY HAVE THIS
BE A SUSTAINABLE PROGRAM HEALTH
CARE SYSTEMS COULD CONTINUE IN
THE FUTURE.
SHE WILL TELL YOU ABOUT HER
PROJECT AND AMAZING COMMUNITY
ENGAGEMENT ACTIVITIES THAT THEY
HAVE BEEN ABLE TO DO AS PART OF
THAT.
I'VE BOLDED THE ONES HERE, THAT
ARE BEING OVERSEEN BY NCCIH
STAFF.
WE HAVE MADE ALL OF THOSE
AWARDS.
WE OVERSEE THIS ENTIRE PROGRAM,
SET OF GRANTS.
SOME ARE WITH OTHER INSTITUTES
AND CENTERS, BUT WE OVERSEE AND
WORK WITH THE COORDINATING
CENTER AS WELL AS ALL OF THE
DIFFERENT INDIVIDUAL PROJECTS
BUT REALLY ALL OF THESE ALMOST
ARE LOOKING AT NON-PHARMACOLOGIC
APPROACHES TO PAIN MANAGEMENT
AND RELEVANT TO NCCIH.
EFFECTIVENESS RESEARCH NETWORK,
ERN, THE GOAL TO DO MULTI-SITE
EFFECTIVENESS TRIALS AND TRY TO
GET COMPARATIVE EFFECTIVENESS,
HOW DOES THIS PAIN TREATMENT
COMPARE TO THIS PAIN TREATMENT
AND SEE WHICH ONE DO PAIN
PATIENTS DO BETTER WITH.
THEY ARE LEVERAGING INVERSE
STRUCTURE AS WELL, CTSA PROGRAM.
THEY HAVE A TRIALS INNOVATION
NETWORK THAT HELPS WITH
RECRUITMENT AND OTHER THINGS.
THOSE TRIALS HAVE ACCESS TO ALL
OF THOSE RESOURCES AND HELP TO
HELP THEM LAUNCH THEIR TRIALS.
NEXT SLIDE.
THIS ISN'T THE FULL LIST OF
TRIALS.
THESE ARE WHAT I THOUGHT WERE
MOST RELEVANT IN TERMS OF BEING
NON-PHARMACOLOGIC OR A
COMBINATION.
SEQUENCING, SHOULD YOU START
WITH CBT AND GO TO MEDICATION,
MAYBE ABLATION, NERVE BLOCK,
REALLY INTERESTING COMPLEX STUDY
DESIGN FOR KNEE OSTEOARTHRITIS.
THE VOWLES APPLICATION, WE'RE
PROVIDING PROJECT SCIENTISTS,
DR. MUDD IS PARTICIPATING IN
THIS ACTIVITY.
AND WE FUNDED AN R34 FOR
PRELIMINARY WORK WHICH LED TO
HIM BEING ABLE TO COMPETE
SUCCESSFULLY FOR THIS ERN TRIAL.
BUT MANY OF THESE INTERVENTIONS
ALSO ARE VERY RELEVANT TO OUR
MISSION AS WELL AND SO THIS
GIVES A SENSE OF WE'RE WORKING
WITH ONE SPECIFICALLY, MANY
PROJECTS DIRECTLY RELATE TO
NCCIH'S MISSION.
I DON'T HAVE TIME TO GO THROUGH
ALL THIS BUT TRIAL INNOVATION
NETWORKS PROVIDES ENORMOUS
AMOUNT OF RESOURCES, TECHNICAL
SUPPORT, ASSISTANCE TO EACH OF
THE TRIALS.
FROM HELPING WRITE PROTOCOLS,
WITH RECRUITMENT ACTIVITIES,
STAKEHOLDER ENGAGEMENT PANEL
THAT THEY HELP THEM DEVELOP,
WHAT MATTERS MOST TO THE
PATIENTS WITH THEIR CONDITION,
IN TERMS OF WHAT SHOULD BE
MEASURED AND WHAT SHOULD BE
COLLECTED.
AND IT GOES ON AND ON.
THE AMOUNT OF RESOURCES PROVIDED
TO THESE TRIALS, IT'S REALLY
JUST PHENOMENAL.
THEY DO THE DATA COORDINATION SO
THEY BUILD THE DATABASE, THE
DATA QUALITY CONTROL, ALL OF
THAT FOR ALL OF THESE STUDIES AS
PART OF THE SUPPORT THAT THIS
NETWORK PROVIDES.
NEXT SLIDE.
TWO LAST SLIDES AND I'LL TURN
OVER TO DR. MURRAY SO HE CAN
MAKE HIS WAY UP HERE.
SO, THERE'S A SET OF PROJECTS WE
FUNDED AS PART OF THE HEAL
INITIATIVE TO REALLY ADVANCE
HEALTH EQUITY WHEN IT COMES TO
PAIN MANAGEMENT.
WE KNOW THERE ARE HUGE
DISPARITIES WHEN IT COMES TO
PAIN MANAGEMENT, WHO GETS ACCESS
TO DIFFERENT TYPES OF SERVICES,
WHO JUST EVEN WHETHER PEOPLE ARE
BELIEVED IN HOW MUCH PAIN THEY
HAVE, VERY STRIKING STATISTICS
ABOUT THE KIND OF CARE PEOPLE
RECEIVE WHEN THEY WALK INTO THE
EMERGENCY DEPARTMENT, FOR
EXAMPLE, EVEN WITH A BROKEN
BONE.
IT'S PHENOMENAL THE DIFFERENCES
IN CARE PEOPLE RECEIVE.
WE HAVE TWO PROJECTS THAT WE'RE
HELPING TO ADMINISTER, ONE IN
PEDIATRIC SICKLE CELL PAIN,
MIND-BODY INTERVENTION,
BEHAVIORAL HEALTH TREATMENT
TOOL.
DR. EVANS, WHO WE MENTIONED
EARLIER, IS ALSO DOING A STUDY
LOOKING AT BACK AND NECK PAIN
USING A SELF-MANAGEMENT TRAINING
PROGRAM.
INTERESTINGLY THIS TARGETS LOW
INCOME POPULATIONS AS THEIR
PRIMARY GROUP THEY ARE LOOKING
AT.
I INCLUDED SEVERAL OTHERS
LOOKING AT GROUP-BASED AND
ACUPUNCTURE STUDY, INTEGRATIVE
CARE APPROACH.
WE'RE NOT SUCCESSFUL GETTING ALL
TO COME TO US TO ADMINISTER.
WE TRY REALLY HARD TO GET ALL OF
THESE ASSIGNED TO US BUT THEY DO
GET SPREAD OUT ACROSS THE
DIFFERENT INSTITUTES AND
CENTERS, SOMETHING "HEAL" TRIES
TO DO TO GET ENGAGEMENT OF AS
MANY INSTITUTES AND CENTERS AS
POSSIBLE AS PART OF THE PROGRAM.
NEXT SLIDE.
AND FINALLY, SECONDARY DATA
ANALYSIS, WE RECOGNIZE THAT
THERE IS A WEALTH OF EXISTING
DATA WE COULD LEARN FROM WHEN IT
COMES TO PAIN MANAGEMENT.
AND SO I THINK TWICE NOW WE'VE
ISSUED FUNDING ANNOUNCEMENTS TO
ENCOURAGE PEOPLE TO LOOK AT THAT
DATA AND DO SOME HYPOTHESIS
GENERATION IN SOME OF THAT WORK.
SO DR. WAGER IS LOOKING AT
CHRONIC PAIN, CHARACTERIZING
BRAIN AND GENETIC PATHWAYS
ACROSS UNDERSTUDIED POPULATIONS.
DR. SMOLEREN LOOKING AT CRITICAL
LIMB ISCHEMIA PAIN, WHAT IS
HAPPENING, HOW IS PAIN BEING
MANAGED, IS IT BEING MANAGED,
AND WHAT DIFFERENT PSYCHOLOGICAL
VARIABLES AND OUTCOMES IN THAT
POPULATION.
I GET TO PASS THE BATON TO DR.
MURRAY AND THEN HE WILL PASS TO
OUR OTHER SPEAKERS.
>> OKAY.
THANKS, WENDY.
THAT WAS A REALLY GREAT JOB
ILLUSTRATING THE HISTORY OF THE
RISE TO OPIOID EPIDEMIC AND THEN
EXPLAINING THE NEED FOR A
PROGRAM LIKE "HEAL" AT NCCIH WE
THINK THERE IS A ROLE THAT
COMPLEMENTARY INTEGRATIVE HEALTH
APPROACHES CAN PLAY IN DEALING
WITH PAIN, IN DEALING WITH
OPIOID USE DISORDER, AND SO
WE'RE DOING WHAT WE CAN TO
LEVERAGE THE "HEAL" PROGRAM AND
MAKE SURE THAT COMPLEMENTARY
INTEGRATIVE APPROACHES PLAY A
ROLE IN THIS PROGRAM.
NEXT SLIDE PLEAT.
I'M SORRY.
PREVIOUS SLIDE.
I'M GOING TO TALK RIGHT NOW
ABOUT THE BRIM PROGRAM THAT DR.
LANGEVIN MENTIONED EARLIER.
SO BEHAVIORAL RESEARCH TO
IMPROVE MEDICATION-ASSISTED
TREATMENT FOR OPIOID USE
DISORDERS.
NEXT SLIDE PLEASE.
SO, THE GOOD NEWS IS THERE ARE
MEDICATIONS THAT HAVE BEEN SHOWN
TO BE SAFE AND EFFECTIVE FOR
TREATING OPIOID USE DISORDER.
THE BAD NEWS IS THAT FOR MANY
PEOPLE WHO NEED THEM, THEY ARE
NOT AVAILABLE.
FOR A LOT OF PEOPLE WHO RECEIVE
THESE MEDICATIONS, ADHERENCE IS
A MAJOR CHALLENGE, WHERE 50%
HAVE DROPPED OUT OF THE
TREATMENT PROGRAMS AT SIX
MONTHS.
ANOTHER COMPLICATION IS THAT NOT
ALL SIZE -- ONE SIZE DOESN'T FIT
ALL.
THE TIMING OF THE TREATMENT
VARIES FOR SOME INDIVIDUALS,
LONGER DURATION INCLUDING YEARS
MIGHT BE NECESSARY TO PREVENT
RELAPSE.
SO, WE REALLY THINK FOR THE BRIM
PROGRAM TARGETING THAT ADHERENCE
ASPECT MIGHT BE THE BEST WAY TO
IMPROVE LONG-TERM OUTCOMES FOR
PEOPLE ENGAGED IN MEDICATION
TREATMENT FOR OPIOID USE
DISORDER.
NEXT SLIDE PLEASE.
I'M GOING TO TALK A LITTLE BIT
ABOUT ADHERENCE DOMAINS AND
NATURE OF ADHERENCE IN GENERAL.
ADHERENCE IS COMPLEX AND
MULTI-FACTORIAL.
BEHAVIORS CHANGE OVER TIME.
THEY ARE NOT STATIC.
AND OF COURSE POOR ADHERENCE IS
NOT LIMITED TO JUST MEDICAL
TREATMENT OF OPIOID USE
DISORDER.
SO, YOU KNOW, ARE THERE LESSONS
THAT CAN BE LEARNED IN ADHERENCE
CHALLENGES OUTSIDE OF MOUD THAT
WE CAN APPLY IN THIS PROGRAM AT
BRIM?
SO, JUST TO TALK ABOUT THE THREE
DIMENSIONS OF ADHERENCE,
INITIATION, ADHERENCE.
INITIATION IS GETTING THEM
STARTED.
IMPLEMENTATION, AND PERSISTENCE,
DO THEY STAY ON LONG ENOUGH TO
REACH SUCCESSFUL TREATMENT.
NEXT SLIDE PLEASE.
AND WE WERE ASKING FOR FULLY
POWERED EFFECTIVENESS TRIALS, OR
TRIALS THAT ARE READY FOR
IMPLEMENTATION SCIENCE WORK IN
THIS PROGRAM.
AGAIN, WITH THE GOAL OF
PREVENTING SUBSTANCE USE
RELAPSE, IMPROVING LONG-TERM
ABSTINENCE FROM ILLICIT OPIOIDS,
SET UP AWARDS AS TWO-PHASE
MILESTONE-DRIVEN AWARDS.
NEXT SLIDE PLEASE.
I'M HAPPY TO SAY THAT THE 14
TRIALS OF THE BRIM PROGRAM, ALL
HAD SUCCESSFULLY -- HAVE
SUCCESSFULLY TRANSITIONED TO THE
SECOND PHASE, NO SMALL FEAT
GIVEN A LOT OF STUFFEDDIES WERE
STARTED IN 2019 AND BEFORE.
HAPPY TO SAY SIX OF THE TRIALS
HAVE PUBLISHED ALREADY ON DATA
FROM THEIR PILOT STUDIES AND
THINGS ARE MOVING SO FAST THAT
THE SECOND BULLET IS OUTDATED,
THREE TRIALS I'M HAPPY TO REPORT
HAVE NOW COMPLETED RECRUITMENT.
AND THEN "HEAL" ISSUED A
SUPPLEMENT ACROSS ALL
"HEAL"-FUNDED STUDIES TO LOOK AT
ROLE OF STIGMA IN, YOU KNOW,
CONTRIBUTING TO THE HEALTH OR
PROVIDING HEALTH CHALLENGE
ACROSS ALL HEAL-FUNDED STUDIES,
SO IN OUR BRIM PROGRAM, YOU
KNOW, FOUR INVESTIGATORS WERE
ABLE TO GO OUT AND GET
ADMINISTRATIVE SUPPLEMENTS TO
ADD WORK THAT ANNUAL ANALYZED E
OF STIGMA IN PROVIDING
ADDITIONAL CHALLENGE TO GAINING
AND SEEKENING
MEDICATION-ASSISTED TREATMENT
FOR OPIOID USE DISORDER.
AND, YOU KNOW, LOOK AT WAYS
WHERE THEY COULD WORK COMPONENTS
INTO INTERVENTION IN ADULTS
SPECIFICALLY WITH STIGMA.
NEXT SLIDE PLEASE.
HERE IS KIND OF A -- TRYING TO
GIVE A SUMMARY OF ALL OF THE
TRIALS, 14 ADMINISTERED BY
NCCIH, TWO TRANSFERRED TO NIDA
IN THE SECOND PHASE.
WHAT I WANT TO POINT OUT HERE IS
THAT TARGET POPULATION THERE'S
SOME MIX THERE, MOSTLY THOSE
WITH OUD, OPIOID USE DISORDER,
BUT SEVERAL STUDIES ARE LOOKING
AT INDIVIDUALS WHO ARE
EXPERIENCING OPIOID USE DISORDER
PLUS CHRONIC PAIN.
AND THEN THE BOTTOM BAR SHOWS
DIFFERENT TYPES OF CLINICS THESE
STUDIES ARE TAKING IN, OPIOID
TREATMENT PROGRAMS OR PRIMARY
CARE SETTINGS.
AND DIFFERENT TYPES OF
MEDICATION PROGRAMS THAT THESE
PEOPLE ARE INITIATING.
OF COURSE, YOU CAN SEE A NICE
DIVERSITY OF COMPLEMENTARY
INTEGRATIVE APPROACHES THAT ARE
BEING IMPLEMENTED ACROSS THE
STUDIES IN BRIM.
NEXT SLIDE PLEASE.
THESE ARE INVESTIGATORS.
I SHOULD HAVE MENTIONED DR.
COOPERMAN'S STUDY, SHOWN ON
THERE, IS ONE OF THE STUDIES TO
HAVE COMPLETED RECRUITMENT, IN
FACT IT WAS THE FIRST TO HAVE
COMPLETED RECRUITMENT, SO
LOOKING FORWARD TO SEEING SOME
OF THEY ARE DATA FROM BOTH
PHASES IN FACT.
BUT THIS IS THE GROUP OF BRIM
INVESTIGATORS.
WE DO HAVE AN INVESTIGATOR
MEETING ONCE A YEAR.
DR. LANGEVIN MENTIONED IT'S
COMING UP IN JUNE, WHERE THE
INVESTIGATORS COME, YOU KNOW,
PRESENT EARLY PILOT DATA THUS
FAR, ALSO KIND OF DISCUSS
CHALLENGES AND SOLUTIONS AND THE
FACT THAT ALL OF THEM
TRANSITIONED TO THE SECOND
PHASE, IT'S BEEN A SUCCESSFUL
MODEL FOR THEM.
NEXT SLIDE PLEASE. .
AND SPEAKING OF SUCCESS THIS IS
A FEW PUBLICATIONS OUT OF THE
BRIM PROGRAM.
LOOKING AT THE FIRST ONE, MARK
FISHMAN'S GROUP, THIS WAS
SUPPORTED BY ANOTHER SUPPLEMENT,
FOCUS OF MECHANISM OF MOUD,
THERAPEUTIC DOSE MEDIATED
RELATIONSHIP BETWEEN
BUPRENORPHINE, NALOXONE, AS A
TREATMENT IN YOUTH WITH OPIOID
USE DISORDER.
I WOULD POINT OUT THE SECOND
PUBLICATION TOO SUPPORTED BY THE
STIGMA SUPPLEMENT, SEAN YOUNG'S
GROUP, SHOWED MISINFORMATION AND
STIGMA CONTRIBUTES TO PEOPLE
HAVING CHALLENGES IN UPTAKE OF
TREATMENT.
AND LASTLY JUST KIND OF A TEASER
FOR THE PRESENTATION LATER ON,
THIS IS DR. COOPERMAN'S STUDY.
THIS PAPER LOOKED AT PILOT DATA,
AND MORE IN INDIVIDUALS
METHADONE TREATMENT AND WE'LL
SEE THE IMPACT ON ILLICIT DRUG
USE, HEALTH AND WELL-BEING.
NEXT SLIDE PLEASE.
NOW I WANT TO TALK ABOUT ANOTHER
PROGRAM.
SO IMPOWR IS ADMINISTERED BY
NIDA PRIMARILY BUT NCCIH DOES
HAVE SOME SECONDARY SUPPORTIVE
ROLES IN THIS PROGRAM.
SO INTEGRATED MANAGEMENT OF
CHRONIC PAIN IN OUD FOR WHOLE
RECOVERY, THIS PIECE IS
IMPORTANT BECAUSE I THINK NCCIH
LANGUAGE AFFECTING HOW OTHERS
THINK
NOT JUST TREATING THE CONDITION
BUT THE CONTEXT IN WHICH THAT
CONDITION EXISTS STIGMA, HEALTH
DISPARITIES, COMORBID
PSYCHIATRIC CONDITIONS PREVALENT
IN THESE POPULATIONS.
NEXT SLIDE PLEASE.
SO, BOTH MEDICATIONS AND
COMPLEMENTARY INTERVENTIONS HAVE
BEEN SHOWN TO BE EFFECTIVE
SEPARATELY FOR OPIOID USE
DISORDER, AND ALSO CHRONIC PAIN.
BUT MUCH LESS IS KNOWN ABOUT HOW
TO INTEGRATE LEVERAGE AND
DELIVER THESE SORT OF COMBINED
INTERVENTIONS TO TREAT
INDIVIDUALS WITH OPIOID USE
DISORDER AND EXPERIENCING
CHRONIC PAIN.
ANOTHER CHALLENGE IS THAT
BECAUSE THESE ARE COMPLEX
INDIVIDUALS, THEY GET -- RECEIVE
CARE FROM MANY DIFFERENT, YOU
KNOW, AREAS OF EXPERTISE AND
SERVICES, AND CLINICS AND
LOCATIONS, AND SO IT REALLY
TENDS TO RESULT IN OFTEN
DISPARATE FRAGMENTED CARE.
AND SO IDEALLY YOU WANT TO
INTEGRATE THAT CARE AND DELIVERY
IN A COORDINATED MANNER.
BUT THERE'S CHALLENGES TO DOING
EXACTLY THAT, INTEGRATING THAT
CARE, LIMITED RESOURCES, LIMITED
EXPERTISE, ALSO LIMITED
COMMUNICATIONS BETWEEN PROVIDERS
AND CLINICS AND SO FORTH.
AND LASTLY, YOU KNOW, THE RISE
IN OPIOID OVERDOSES THAT ARE
LINKED TO COVID-19, WITH TIMING
OF THIS STUDY, THIS PROGRAM
REALLY JUST ADDED A MORE ACUTE
AND CATASTROPHIC CHALLENGE TO
FIXING THE THINGS THIS STUDY IS
INTENDING TO FIX.
NEXT SLIDE PLEASE.
SO, HOW ARE THEY GOING TO
ADDRESS THESE CHALLENGES TO
DEVELOP INTERVENTIONS THAT ARE
NOT ONLY EFFECTIVE BUT COST
EFFECTIVE, THAT INTEGRATE
TREATMENT FOR BOTH CHRONIC PAIN
AND OPIOID USE DISORDER?
AND, AGAIN, THESE ARE COMPLEX
INDIVIDUALS.
SO, YOU KNOW, HOW BEST TO
COORDINATE THEIR CARE, WHAT ARE
THOSE CARE DELIVERY MODELS THAT
PROVIDE THE BEST AND EFFICIENT
AND EFFECTIVE CARE FOR THESE
INDIVIDUALS?
AND LASTLY, IDENTIFY BARRIERS
AND SOLUTIONS TO DEVELOP
EFFECTIVE IMPLEMENTATION
STRATEGIES.
SO THAT THESE INTERVENTIONS CAN
BE IMPLEMENTED IN A LONG-TERM
SUSTAINED MANNER.
NEXT SLIDE PLEASE.
ULTIMATELY IMPOWR AIMS TO
GENERATE PATIENT-CENTERED
SOLUTIONS FOR INTEGRATED
MANAGEMENT OF CO-OCCURRING PAIN
AND OPIOID USE DISORDER, AND
THEN COMMUNICATE THOSE FINDINGS
EFFECTIVELY TO THE KEY
STAKEHOLDERS AND TO AS QUICKLY
AS POSSIBLE MAKE AN IMPACT ON
PUBLIC HEALTH.
NEXT SLIDE PLEASE.
OH, THREE MORE TIMES.
YES, THAT'S GOOD.
THEY ARE GOING TO MAKE THIS MOST
EFFECTIVE BY NUMBER ONE
MAXIMIZING GENERALIZABILITY, CAN
THESE INTERVENTIONS BE
IMPLEMENTED IN DIVERSE SETTINGS?
AGAIN FOCUSING ON THE WHOLE
PATIENT, YOU KNOW, REALLY TAKING
INTO CONSIDERATION THE COMORBID
PSYCHIATRIC CONDITIONS AND
ADDRESS HEALTH EQUITIES, I
MENTIONED STIGMA,
DISCRIMINATION, THOSE SORTS OF
ASPECTS ARE GOING TO BE INFORMED
BY ENGAGING PARTNERS, ENGAGING
COMMUNITY CLINICIANS, ALSO
PEOPLE WITH LIVED EXPERIENCE.
AND THEN, YOU KNOW, IMPOWR FEELS
THE NEED TO SEED THE FIELD FOR
THE FUTURE OF RESEARCH IN
ADDRESSING CHRONIC PAIN AND
OPIOID USE DISORDER, SO SPECIAL
CONSIDERATION IS GIVEN TO
EARLY-STAGE INVESTIGATORS TO
BUILD THE CROP OF YOUNG EARLY
CAREER INVESTIGATORS.
OH, SORRY, YEAH.
SO, AGAIN IMPOWR IS NOT
SPECIFICALLY INCLUDING
COMPLEMENTARY INTEGRATIVE HEALTH
APPROACHING BUT I WANT IN AND
PULLED OUT THESE FIVE STUDIES
THAT ARE USING THESE
COMPLEMENTARY HEALTH APPROACHES,
AND INTERVENTIONS THEY ARE
USING, SO I THINK THIS IS GREAT,
YOU KNOW, REALLY ALSO EXPANDS
THE SCOPE OF COMPLEMENTARY
APPROACHES, YOU KNOW, PAST
WHAT'S ALREADY GOING ON IN BRIM.
NEXT SLIDE PLEASE.
SO I THINK -- AM I GOING TO GO
THROUGH THESE?
OKAY.
SHIFTING AGAIN, "HEAL" IS A
REALLY BIG PROGRAM.
SO IT'S REALLY EXPANDED THE
AMOUNT OF PAIN RESEARCH THAT'S
BEING CONDUCTED.
YOU KNOW, WE NEED TO EXPAND THE
FIELD OF RESEARCHERS, SO "HEAL"
IS IMPLEMENTING A K-12 MENTORED
CAREER PROGRAM FOR CLINICIANS,
SPECIFICALLY TO DO CLINICAL
RESEARCH TO STUDY PAIN, NEXT
SLIDE PLEASE.
IT'S A NATIONAL MENTORING
PROGRAM.
YOU KNOW, AS I MENTIONED, IT'S
GOING TO ENHANCE CLINICAL PAIN
RESEARCH WORKFORCE.
THEY ARE GOING TO DEVELOP
GUIDELINES TO MAXIMIZE EFFECTIVE
MENTORING AND CAREER
DEVELOPMENT.
AND THEN AT THE END HELP
SCHOLARS SUCCESSFULLY TRANSITION
INTO INDEPENDENCE AFTER THE
TRAINING AND VERY IMPORTANTLY
THEY ARE GOING TO COLLABORATE
WITH THE PURPOSE NETWORK, WHICH
DR. LANGEVIN MENTIONED IS
MEETING LITERALLY YESTERDAY AND
TODAY.
AND I GUESS I WOULD SAY THAT
THERE WAS A FUNDING
ANNOUNCEMENT, FUNDING
OPPORTUNITY, AND THE FIRST THREE
SCHOLARS HAVE BEEN SELECTED, AND
THEY ARE ENGAGING IN TRAINING
BOOT CAMP THIS SUMMER.
ANOTHER CALL FOR APPLICATIONS IS
GOING TO GO OUT IN THE FALL FOR
APPLICATIONS IN THE SPRING, SO
KEEP YOUR EYES OPEN ON THE
"HEAL" AND NCCIH WEBSITES.
NEXT SLIDE PLEASE.
SO THE K23 MENTORING PROGRAM IS
LEVERAGING THIS PURPOSE NETWORK,
AND I THOUGHT I HAD THE ACRONYM,
TO EXPLAIN THE ACRONYM.
BUT ANYWAY THE PURPOSE NETWORK
IS REALLY CENTERED ON A DIGITAL
PLATFORM THROUGH WHICH A
COMMUNITY OF RESEARCHERS,
TRAINEES, MENTORS, CAN CONNECT
AND COLLABORATE
MULTI-DISCIPLINARY
COLLABORATIONS, YOU KNOW, WRITE
GRANTS TOGETHER.
THERE'S OPPORTUNITIES FOR
TRAINING THROUGH WEBINARS, AND
SO FORTH.
AND SO THERE'S ALREADY 900
INDIVIDUALS THAT ARE PART OF THE
NETWORK, AND I WANT TO ENCOURAGE
COUNCIL MEMBERS TO GO TO THE
NETWORK AND SIGN UP TO BE EITHER
A MENTOR OR MENTEE, AND THE
WIDER COMMUNITY.
NEXT SLIDE PLEASE.
>> GREAT, LET'S TURN THINGS
OVER TO DR. MORONE.
WE'LL TAKE A BRIEF BREAK OR TAKE
A PAUSE SO DR. MORONE CAN ANSWER
SPECIFIC QUESTIONS ABOUT HER
PRESENTATION AND SCIENCE SHE'S
PRESENTED AND WE'LL GO TO DR.
COOPERMAN AND TAKE QUESTIONS FOR
HER AND A BROADER DISCUSSION.
>> THANK YOU SO MUCH.
CAN I HAVE THE NEXT SLIDE?
CAN YOU HEAR ME?
>> YES, WE CAN HEAR YOU.
>> SO, I WAS GOING TO -- WE
DON'T HAVE TO GO TO MY ORIGINAL
SLIDE.
I'M NATALIA MORONE, BOSTON
UNIVERSITY, BOSTON MEDICAL
CENTER, PRIMARY CARE PHYSICIAN,
A GENERAL INTERNIST.
I'M DELIGHTED TO SPEAK TO YOU
TODAY, I'M HONORED TO ASK TO
SPEAK ABOUT THE PRAGMATIC TRIAL
I'M RUNNING, PARTICULARLY ABOUT
THE COMMUNITY ADVISORY BOARD AND
STAKEHOLDER ENGAGEMENT THAT
WE'VE IMPLEMENTED.
OPTIMIZING PAIN TREATMENT IN
MEDICAL SETTINGS USING
MINDFULNESS IS A PRAGMATIC
CLINICAL TRIAL, INTEGRATING
TELEHEALTH GROUP-BASED STRESS
REDUCTION PROGRAM, PRIMARY CARE
SETTING.
PERSONS WITH CHRONIC LOW BACK
PAIN.
WE ORIGINALLY MET IN PERSON, THE
PANDEMIC TURNED IT INTO A
TELEHEALTH PROGRAM.
IT'S A PRAGMATIC RANDOMIZED
TRIAL, PARTICIPANTS ARE FOLLOWED
OVER ONE YEAR.
WE ARE RECRUITING 450 PATIENTS
WITH CHRONIC LOW BACK PAIN AT
LEAST 18 YEARS OF AGE, THREE
HEALTH CARE SYSTEMS, BOSTON
MEDICAL CENTER WHERE I AM
LOCATED IS A SAFETY NET HEALTH
SYSTEM.
UPMC IS UNIVERSITY OF
PITTSBURGH, IN PITTSBURGH, AND
AFFILIATED WITH MY COLLEAGUES AT
THE UNIVERSITY OF PITTSBURGH.
AND THEN THE UNIVERSITY OF NORTH
CAROLINA AT CHAPEL HILL,
PARTICULARLY PIEDMONT HEALTH
SERVICES, A FEDERALLY QUALIFIED
COMMUNITY HEALTH CENTER.
HALF OF THE GROUP, 225
PARTICIPANTS, GET THE 8-WEEK
MINDFULNESS PROGRAM, AND THE
OTHERS GET THE USUAL PRIMARY
CARE.
PRIMARY OUTCOME IS LOOKING AT
PAIN INTENSITY AND PAIN
EXPERIENCE IN ENJOYMENT OF LIFE
AND PHYSICAL FUNCTION.
WE'RE LOOKING AT OTHER SECONDARY
MEASURES LIKE PSYCHOLOGICAL
FUNCTION, PHYSICAL FUNCTIONING,
HEALTHCARE UTILIZATION, PAIN
MEDICATION, OPIOID USE, LIKE ANY
PAIN CLINICAL TRIAL WE HAVE TO
HAVE MULTI-DISCIPLINARY MEASURES
FOR OUR OUTCOME.
NEXT SLIDE.
PRIMARY HYPOTHESIS IS THAT
PATIENTS WILL HAVE SIGNIFICANTLY
IMPROVED PAIN INTENSITY AND
INTERFERENCE MEASURED BY THE PG
SCORE AT COMPLETION AT SIX AND
TWELVE MONTHS LATER COMPARED TO
USUAL CARE.
WE WANT TO SEE WITH ANY PAIN
INTERVENTION THAT THERE IS
EFFECT OVER TIME, IT'S NOT JUST
LIKE A TYLENOL WHERE IT HELPS MY
HEADACHE RIGHT NOW BUT IT'S
NOTHING LONG TERM.
NEXT SLIDE.
TWELVE PARTICIPANTS WITH CHRONIC
LOW BACK PAIN ARE REFERRED OR
SELF-IDENTIFIED.
COMPLETE BASELINE SURVEYS ALL
ONLINE.
THEY GET RANDOMIZED TO ONE OF
TWO GROUPS.
THEY PARTICIPATE IN THE
PROGRAMS, AND ALSO WE TAKE
SURVEYS MONTHLY AT 8 WEEKS, 6
MONTHS, 12 MONTHS.
SO THE CLINICAL TRIAL IS
COMPLETELY -- PRAGMATIC CLINICAL
TRIAL IS COMPLETELY VIRTUAL.
NEXT SLIDE.
AGAIN, CLINICAL PAIN MANAGEMENT
PROGRAM IS MODELS ON THE
MINDFULNESS BASED STRESS
REDUCTION PROGRAM, NOW AN
EVIDENCE-BASED TREATMENT FOR
PERSONS WHO HAVE CHRONIC LOW
BACK PAIN AS LONG AS THE PRIMARY
FIRST LINE INTERVENTION FOR
PEOPLE WITH CHRONIC LOW BACK
PAIN.
EIGHT WEEKLY 90-MINUTE SESSIONS
GROUP BASED DELIVERED IN PRIMARY
CARE, SO TELEHEALTH MEDICAL
GROUP VISIT MODEL.
NEXT SLIDE.
HOW DOES THAT WORK?
THE PATIENTS SIGN INTO THE GROUP
ZOOM AND WILL HAVE A MINDFULNESS
INSTRUCTOR, PRIMARY CARE
PROVIDERS.
PATIENTS MEET WITH PROVIDER FOR
A BRIEF CHECK-IN IN A BREAKOUT
ROOM PRIOR TO THE START OF THE
SESSION.
AND THE PATIENT RETURNS TO THE
FULL GROUP TO PARTICIPATE IN THE
MINDFULNESS PROGRAM.
NEXT SLIDE.
A SNAPSHOT OF WHERE WE'RE
CURRENTLY AT, WE HAVE SCREENED
1247 PEOPLE, IF YOU KIND OF GO
DOWN ALL THE ROWS, WE RANDOMIZED
366 PEOPLE SO WE'RE GETTING
CLOSE.
WE RANDOMIZE IN COHORTS BECAUSE
OF THE NATURE OF THE WAY THE
TRIAL IS SET UP, THERE'S STILL
PEOPLE IN WAITING TO BE
RANDOMIZED.
NOW SHIFTING TO STAKEHOLDER
ENGAGEMENT AND WORK WITH
STAKEHOLDER ENGAGEMENT.
NEXT SLIDE.
AND WHO ARE THE STAKE HOLDERS?
THEY COME FROM GROUPS AND
ORGANIZATIONS, HEALTH CARED A
34-R9ORS, ADVOCATES, COMMUNITY
MEMBERS, POLICYMAKERS, MIGHT
BRING SEVERAL PERSPECTIVES TO
ANY PROJECTS.
COMMUNITY ADVISORY BOARD
MEMBERS, STAKEHOLDERS FROM
VARIOUS BACKGROUNDS, WHO EACH
BRING UNIQUE PERSPECTIVES AND
EXPERTISE TO THE TABLE.
NEXT SLIDE.
SO, THE CONTRIBUTIONS OF CAB,
FOR SHORT, THE FEEDBACK AND
ADVICE THEY PROVIDE, A LOT
IDENTIFY ABOUT LIVING WITH
CHRONIC PAIN, CHRONIC LOW BACK
PAIN, GIVE ADVICE HOW TO ENGAGE
WITH PROVIDERS WHO SERVE AS
PARTICIPANTS, PROVIDE
MINDFULNESS AND PRIMARY CARE AND
ADVICE ON RESISTANCE TO
MINDFULNESS FOR TREATING PAIN.
ASSISTANCE WITH TAILORING
RECRUITMENT AND METHODS, AS YOU
CAN IMAGINE, THAT'S WHAT WE'RE
WORKING ON NOW.
REALLY WE WILL BE ENGAGING THEM
MORE AND MORE ON NEXT STEPS FOR
DISSEMINATION.
NEXT SLIDE.
WHO WHO MAKES UP OUR CAB?
WE HAVE PEOPLE WHO HAVE CHRONIC
LOW BACK PAIN, THAT GOES WITHOUT
SAYING THAT'S CRITICAL.
BUT GIVEN THE MOSTLY
DISCIPLINARY NATURE OF THIS
STUDY WE HAVE MINDFULNESS
INSTRUCTORS, WE HAVE HEALTH CARE
PROFESSIONALS, WE HAVE PAIN
ADVOCACY GROUP LEADERS AND
ADMINISTRATORS.
SO WE TRY TO CREATE A CAB WITH A
BREADTH OF VIEWPOINTS AND NOT
JUST THE RESEARCH VIEWPOINT THAT
ME AS A PRINCIPAL INVESTIGATOR
WILL BRING.
WE HAVE TEN MEMBERS IN OUR CAB.
WE DO MEET MONTHLY FOR AN HOUR.
PEOPLE ARE REIMBURSED.
THIS WAS CONSCIOUS TO DO IT
MONTHLY, NOT ALL CABs ARE DONE
MONTHLY BUT I WANTED TO
INTEGRATE AND THEIR FEEDBACK AS
PART OF THE TEAM SO THAT IT
COULD BE DIRECTLY IMPLEMENTED
WHAT THEY HAVE RECOMMENDED FOR
US.
NEXT SLIDE.
SO HOW DO WE EVEN START THIS?
WELL, WHAT I USE AND WHAT WE USE
WAS CONNECTING COMMUNITIES TO
RESEARCH, A TOOLKIT.
THIS WAS DEVELOPED BY COLLEAGUES
AT BOSTON MEDICAL CENTER, AND IS
AVAILABLE FREELY THROUGH PCORI.
IT IS A STEP-BY-STEP GUIDE TO
TRAIN THE CAB.
I LISTED A LIST OF FOLKS WITH NO
EXPERIENCE IN RESEARCH.
SO IT'S VERY CRITICAL TO
INTRODUCE THEM TO THE RESEARCH
PROCESS AND REALLY SO THE CABs
DEVELOP AN UNDERSTANDING OF
CONTRIBUTIONS AS PARTNERS IN
RESEARCH STUDY.
SO, THEY PARTICIPATED IN A
TWO-HOUR TRAINING.
THIS TOOLKIT LITERALLY GOES OVER
STEP BY STEP AND HAS A
POWERPOINT PRESENTATION OF WHAT
YOU MIGHT INCLUDE.
SO WE OF COURSE TAILORED TO THE
OPTIMUM STUDY BUT IT WAS VERY
HELPFUL TO USE THIS AS A BASIC
TRAINING FOR ALL OF THE CAB
MEMBERS TO BEGIN THE JOURNEY
WITH US.
NEXT SLIDE.
SO WHAT ARE THE TOPICS?
ONE, I WILL SAY THIS IS SOMEWHAT
FLUID BECAUSE IF THINGS COME UP,
BECAUSE THEY ARE MEETING MONTHLY
IF SOMETHING COMES UP NOW IN THE
STUDY WE LIKE THEIR FEEDBACK
MIGHT BRING THAT UP AT THIS
MONTH'S MEETING BUT FOR SURE
THEY WERE INVOLVED IN LOOKING AT
OUR RECRUITMENT MATERIALS SUCH
AS FLYERS, WEBSITES, ANIMATED
VIDEO WE CREATED, LOOKED AT
LANGUAGE USED IN STUDY
MATERIALS, BRAINSTORMED
STRATEGIES FOR STUDY
PARTICIPATION AND RECRUITMENT,
AND WE GIVE THEM UPDATES ON
STUDY PROGRESS.
NEXT SLIDE.
SO, CAB WORK FLOW IS A CYCLE,
THE COMMUNITY ADVISORY BOARD
MEETS, THEY REVIEW THE MATERIALS
THAT WE PRESENT TO THEM AND THEY
DISCUSS STRATEGIES OR MAKE
RECOMMENDATIONS BASED ON THAT.
WE CREATE A LIGHTNING REPORT,
SEVEN DAYS OF THE CAB MEETING,
I'LL REVIEW THAT IN A MOMENT.
THEN WE TAKE THAT LIGHTNING
REPORT AND WE MEET EVERY TWO
WEEKS BRING THAT REPORT TO THE
ENTIRE TEAM FOR DISCUSSION
WITHIN FOUR WEEKS, TRY TO
IMPLEMENT RECOMMENDATIONS AND
BRING BACK WHAT WE'VE
IMPLEMENTED TO THE CAB AND THE
CYCLE STARTS ALL OVER AGAIN.
NEXT SLIDE.
SO LIGHTNING REPORT IS A RAPID
QUALITATIVE ANALYSIS METHOD, THE
WAY WE'VE IMPLEMENTED, TWO NOTE
TAKERS DURING THE CAB MEETING,
AND THEY SUMMARIZE IN THIS WAY
THAT'S SHOWN HERE THE MEETING OF
THE CAB.
SO WHAT'S WORKING, WHAT NEEDS TO
CHANGE, OVERALL INSIGHT, ACTION
ITEMS.
AND A LITTLE EXECUTIVE SUMMARY.
THIS IS A VERY FAST WAY TO
ORGANIZE THE RECOMMENDATIONS OF
THE CAB MEETING AND THIS IS
LITERALLY WHAT WE BRING TO THE
WHOLE TEAM TO DISCUSS.
NEXT SLIDE.
I WANT TO SHOW YOU CONCRETE
EXAMPLES.
ON THE LEFT THE ORIGINAL FLYER
SHOWN TO CAB.
THEY HAD A LOT OF OPINIONS ABOUT
IT.
ONE IS THEY FELT THAT EVERYBODY
WITH CHRONIC PAIN RESEARCH SHOWS
IMAGE OF SOMEBODY HOLDING THEIR
BACK AND IN PAIN.
THEY REALLY DO NOT LIKE THAT.
THEY ACTUALLY WANTED US TO HAVE
NATURE, PICTURES OF NATURE.
AND SO WE TOOK THAT TO HEART.
THE OTHER THING THAT THEY REALLY
WANTED IS FOR US TO MENTION
MINDFULNESS.
THEY UNDERSTOOD PEOPLE MAY BE
RANDOMIZED TO USUAL CARE,
NEVERTHELESS FELT IT WAS
IMPORTANT THAT THE PEOPLE WHO
SAW THIS FLYER UNDERSTOOD THIS
WAS A STUDY FOR MINDFULNESS.
NEXT SLIDE.
AGAIN, SAME WITH THE IMAGE.
DID NOT LIKE THE GRIMACING
PERSON HOLDING THEIR BACK.
WE'VE SEEN IT A MILLION TIMES,
IT'S NOT INNOVATIVE OR CREATIVE.
SO, SOME OF THE LANGUAGE FOR
EXAMPLE HAVE YOU METHOD ABOUT
MINDFULNESS FOR YOUR CHRONIC LOW
BACK PAIN, THAT'S DIRECTLY THE
LANGUAGE THAT THEY WERE
RECOMMENDING US TO USE.
THEY WERE VERY CLEAR THEY DID
NOT WANT US TO MENTION HOW MUCH
COMPENSATION PARTICIPANTS MAY
GET.
ALSO I WANT TO POINT OUT THEY
DID THE NATION SCENE MENTIONING
MINDFULNESS FROM PATIENTS WITH
CHRONIC LOW BACK PAIN WHO
PARTICIPATED IN THE 8-WEEK
PROGRAM.
SO THEY WERE BOTH FAMILIAR WITH
LIVING WITH CHRONIC PAIN AND
HAVING GONE THROUGH A
MINDFULNESS PROGRAM.
NEXT SLIDE.
ANOTHER SUGGESTION, THE CAB, I
SHOWED THIS TO YOU EARLIER GOING
THROUGH THE FLOW OF THE STUDY,
THEY DID NOT LIKE THE ORIGINAL
PROVIDER IMAGE CARTOON YOU SEE
ON THE LEFT, SO YOU SEE WE ALSO
CHANGED THAT.
AGAIN, BRING THEM WHAT WE CHANGE
AND THEY GIVE US FEEDBACK, AND
IF EVERYONE LIKES IT WE BRING IT
TO THE IRB FOR APPROVAL.
NEXT SLIDE.
WHAT ABOUT LANGUAGE AND
RECRUITMENT APPROACH?
THIS WAS VERY HELPFUL.
WHEN THEY LOOKED AT ORIGINAL
RECRUITMENT LETTER SAID YOU NEED
TO ADD CONFIDENTIALITY LANGUAGE.
PEOPLE WHO ARE PARTICIPATING IN
A STUDY NEED TO KNOW THAT
EVERYTHING THAT YOU'RE
COLLECTING FROM THEM WILL BE
CONFIDENTIAL.
SO WE ADDED THAT.
THEY ALSO HELPED WITH
RECRUITMENT, HAD A LOT OF
DISCUSSION ON THE INFORMATION
THAT NEEDS TO BE BROUGHT TO
PARTICIPANTS WHEN SPEAKING ON
THE PHONE, FOR EXAMPLE, REALLY
WHAT ARE THE BENEFITS OF
PARTICIPATING IN RESEARCH AND
WHY WOULD YOU EVEN WANT TO
PARTICIPATE IN RESEARCH.
THEY WANTED THEM TO HAVE MORE
INFORMATION ON THE BENEFITS OF
MINDFULNESS.
SO INTERESTINGLY, YOU THINK OF
WHO DOES THAT IN CLINICAL TRIAL,
OF COURSE IT'S RESEARCH
ASSISTANTS, WHO HAVE THE MOST
ONE-TO-ONE DIRECT CONTACT WITH
POTENTIAL PARTICIPANTS.
THIS LED TO A REALLY RICH STUDY
AMONG ALL THREE SITES, AND
RESEARCH ASSISTANTS, ON ACTUAL
TALKING POINTS, TO SPEAK WITH TO
A PARTICIPANT AND ALSO HELP ME
UNDERSTAND EVEN SOME RESEARCH
ASSISTANTS DIDN'T COMPLETELY
UNDERSTAND ALL THE EVIDENCE BASE
BETWEEN MINDFULNESS AND CHRONIC
LOW BACK PAIN SO IT WAS AN
EDUCATIONAL OPPORTUNITY.
WE DEVELOPED TALKING POINTS THAT
TO THIS DAY THEY HAVE
CONSISTENTLY USED.
NEXT SLIDE.
"HEAL" IS GENEROUS IN THE
INVOLVEMENT OF STAKEHOLDERS, AND
WHAT YOU'RE SEEING LEER IS --
HERE IS A PICTURE OF THE ANNUAL
MEETING WITH A POSTER SESSION,
WE INVITED AMY GOLDSTEIN WHO IS
ONE OF OUR CAB MEMBERS, TO
PARTICIPATE IN THE POSTER
SESSION, AND SO YOU SEE HER
THERE ALONG WITH ISABELLE ROTH
WHO AS A K01 FROM NCCIH IS A
STRONG LEADER IN THE STAKEHOLDER
ENGAGEMENT.
SO, I'M APPRECIATIVE OF HOW
GENEROUS "HEAL" HAS BEEN IN
INVITING THE YOUNG EARLY
INVESTIGATORS BY PROVIDING
TRAVEL AWARDS TO "HEAL" MEETINGS
AND ALSO STAKEHOLDERS WHICH IS
VERY EXCITING.
NEXT SLIDE.
I DO WANT TO ACKNOWLEDGE IT
TAKES A VILLAGE, AS THEY SAY.
AND IT DOES FOR THE OPTIMUM
STUDY ALSO.
SO SUSAN, KIM, CAROL, AND
KATHLEEN ARE THE SITE P.I.s,
AND I'M INDEBTED TO THEM AND THE
TEAM AND ALL CAB MEMBER STUDY
PARTICIPANTS, NIH PRAGMATIC
TRIAL COLLABORATORY REALLY
DOES -- IS AN ESSENTIAL PART OF
BIGGER TEAM AND OF COURSE WENDY
WEBER IS OUR PROGRAM OFFICER.
I'D LIKE TO THANK EVERYBODY FOR
THEIR ATTENTION TODAY AND I'M
HAPPY TO ANSWER ANY QUESTIONS.
>> THANKS, NATALIA.
WE'LL TAKE FIVE MINUTES, IF
PEOPLE HAVE SPECIFIC QUESTIONS,
AND WE'LL MOVE TO DR. COOPERMAN
AND HER PRESENTATION.
SO, YEAH?
>> THANK YOU FOR THIS VERY
INTERESTING TALK.
I CAN'T WAIT TO HEAR THE
RESULTS, ONCE YOU FINISH THE
RECRUITMENT, BUT WHAT I WANTED
TO UNDERSTAND IS, IS THERE A
MEASURE IN YOUR TRIAL DESIGN AS
TO HOW YOU CAN TEST WHETHER OR
NOT THE STUDY PARTICIPANTS ARE
ACTIVELY DOING THE MINDFULNESS?
I MEAN, ARE SOME DOING IT BETTER
THAN OTHERS?
>> RIGHT.
THAT'S AN EXCELLENT QUESTION.
AS A PRAGMATIC TRIAL, WE -- I
DID THIS IN MY ORIGINAL R01, MY
EFFICACY TRIAL.
I KNEW IN THE CLINICAL SETTING
THIS WOULD BE LESS LIKELY THAT
PROVIDERS WERE LESS LIKELY TO BE
CHECKING IN.
BUT I WILL TELL YOU HOW WE'RE
DOING IT.
I MENTIONED THAT THE PRIMARY
CARE PROVIDER CHECKS IN EVERY
WEEK WITH PARTICIPANTS.
AND SO PART OF THE NOTE THAT SHE
WRITES, SHE'S ACROSS SITES NOW
THAT I THINK ABOUT IT, THE
PROVIDER, WE ASK THEM WHAT
MEDITATIONS THEY HAVE BEEN DOING
IN THE PAST WEEK.
SO, IT'S NOT BEING COLLECTED THE
WAY I MIGHT DO AN EFFICACY TRIAL
WHERE, YOU KNOW, YOU MIGHT HAVE
YOUR APP WHERE YOU'RE COLLECTING
IT BUT WE'RE COLLECTING IT
THROUGH THE MEDICAL RECORDS AND
THAT POTENTIALLY WILL BE A WAY
FOR US TO CAPTURE SOME OF IT.
>> GREAT.
THANKS.
OTHER QUESTIONS?
YES?
>> JUST A COMMENT.
I'D LIKE TO SAY THANKS FOR
SHARING THE PATIENT FEEDBACK
THAT YOU GOT ABOUT SHAPING THE
RECRUITMENT MATERIALS.
THAT'S REALLY, REALLY HELPFUL.
I'M ACTUALLY IN A LITTLE --
DOING A FEW INTERACTIONS WITH
OUR P.R. ABOUT MY OWN PATIENT
FLYERS, IT'S LIKE, WOW, I SHOULD
ACTUALLY ASK MY PATIENTS WHAT
WOULD BE BEST.
SO THANKS A BUNCH FOR BRINGING
THAT UP.
>> YOU KNOW WHAT?
IT SURPRISED ME.
I'M A CLINICIAN ALSO.
AND AS A RESEARCHER, I THOUGHT
OF COURSE THESE PATIENTS WANT TO
SEE SOMEONE HOLDING THEIR BACK.
YOU KNOW WHAT?
THEY DON'T.
SO, THAT WAS VERY HELPFUL.
I HAVE TO ADMIT I LIKE --
THERE'S MORE NATURE SCENES I
DIDN'T SHOW.
I KIND OF LIKE THE NATURE SCENES
BETTER.
IT MAKES SENSE TO ME FROM A
MINDFULNESS PERSPECTIVE ANYWAY.
>> GREAT.
THANKS SO MUCH.
WE'LL HAVE TIME FOR MORE OPEN
DISCUSSION AT THE END WHEN WE
GET THROUGH THE NEXT
PRESENTATION.
DR. COOPERMAN, ARE YOU READY TO
JOIN US?
LET'S SEE IF WE CAN HEAR YOU.
>> CAN YOU HEAR ME?
>>YES, WE CAN.
I THINK WE'RE ALL SET.
WE'LL TURN THINGS OVER TO YOU.
>> GREAT.
THANK YOU SO MUCH.
SO WE CAN GO TO THE NEXT SLIDE.
SO, I'M GOING TO BE TALKING
ABOUT MINDFULNESS-ORIENTED
RECOVERY ENHANCEMENT AS ADJUNCT
TO METHADONE TREATMENT FOR
OPIOID USE AND CHRONIC PAIN
TODAY.
I'M DR. NINA COOPERMAN,
ASSOCIATE PROFESSOR IN THE
DIVISION OF OF ADDICTION
PSYCHIATRY AT RUTGERS ROBERT
WOOD JOHNSON MEDICAL SCHOOL.
THANK YOU FOR INVITING ME,
LOOKING FORWARD TO PRESENTING
RESULTS TO ALL OF YOU.
NEXT SLIDE.
JUST TO GIVE AN OVERVIEW ABOUT
WHAT I'M GOING TO TALK ABOUT, SO
I'M GOING TO GIVE A RATIONALE
FOR THE PROJECTS THAT I'M GOING
TO GIVE YOU THE RESULTS FOR AND
TELL YOU THAT FIRST A SMALL
PILOT STUDY, R21 PILOT STUDY OF
30 INDIVIDUALS, AND WE DID A
LARGER STUDY WITH OUR R33 GRANT.
AND I'LL TELL YOU ABOUT WHAT
WE'RE, WORKING ON NOW, WHAT NEXT
STEPS ARE.
NEXT SLIDE.
BEFORE I GET STARTED I WANT TO
ANNUAL MY WONDERFUL TEAM,
INCLUDING MY CO-INVESTIGATORS AT
RUTGERS AND UNIVERSITY OF UTAH
AND STAFF.
WE HAD WONDERFUL NEW JERSEY
METHADONE CLINICS AND CLIENTS
THAT PARTICIPATED IN THIS
RESEARCH.
NEXT SLIDE.
SO, AS WE'VE HEARD, THE U.S. HAS
BEEN EXPERIENCING AN EPIDEMIC OF
OPIOID USE DISORDER, OUD, AND
OPIOID OVERDOSE.
THERE'S A GREAT NEED FOR
EFFECTIVE TREATMENTS TO HELP
INDIVIDUALS WITH OPIOID USE
DISORDER BECOME AND STAY
ABSTINENT FROM A LIST OF ILLICIT
DRUGS.
MEDICATION COMBINED WITH
COUNSELING AND THERAPY IS THE
MOST EFFECTIVE TREATMENT FOR
OPIOID USE DISORDER AND
METHADONE IS THE MOST COMMON
MEDICATION FOR OPIOID USE
DISORDER.
TO RECEIVE METHADONE, FOR OPIOID
USE DISORDER, INDIVIDUALS ATTEND
A METHADONE CLINIC AND THEY GET
THEIR METHADONE AT THE CLINIC,
WHERE YOU CAN EARN DOSES OR
TAKEHOME DOSES FOR ABSTINENCE
FROM DRUGS.
AND ALSO USUALLY IS PART OF THE
METHADONE CLINIC TREATMENT,
INDIVIDUAL AND GROUP THERAPY IS
AVAILABLE WITH VARYING INTENSITY
AND FREQUENCY.
HOWEVER, AS PETER MENTIONED, 50%
OF THOSE WHO BEGIN METHADONE
TREATMENT DISCONTINUE WITHIN A
YEAR, AND OF THOSE WHO REMAIN IN
TREATMENT 50% RELAPSED TO OPIOID
USE WITHIN SIX MONTHS.
SO, THIS COULD BE DUE TO
UNDERLYING FACTORS LIKE CHRONIC
EMOTIONAL AND PHYSICAL PAIN THAT
NEED TO BE ADDRESSED.
AND NOVEL BEHAVIORAL
INTERVENTIONS ARE NEEDED AS
ADJUNCTS TO METHADONE TREATMENT
TO IMPROVE OUTCOMES.
NEXT SLIDE.
MINDFULNESS-ORIENTED RECOVERY
ENHANCEMENT, MORE, IS AN
INTERVENTION THAT COULD ADDRESS,
BUT NEVER AS EFFECTIVE AS
METHADONE, DEVELOPED BY DR. ERIC
GARLAND, UNIVERSITY OF UTAH,
FOUND TO BE EFFICACIOUS FOR
REDUCING PRESCRIBED OPIOID
MISUSE AMONG PAIN PATIENTS AND
PRIMARY CARE SETTINGS.
RECENT STUDY OF MORE COMPARED TO
A SUPPORT GROUP AND PRIMARY CARE
PUBLISHED IN JAMA INTERNAL
MEDICINE FOUND MISUSE AT 45 PTZ.
%.
MORE IS AN 8-SESSION GROUP
INTERVENTION THAT INCLUDES
TRAINING AND OF IN MINDFULNESS,
COGNITIVE REAPPRAISAL, POSITIVE
EMOTION REGULATION SKILLS.
AND STUDIES I'M PRESENTING TODAY
ARE THE FIRST TO EVALUATE MORE
AMONG PEOPLE WITH AN OPIOID USE
DISORDER AND IN TREATMENT, AND
ON ANY MEDICATION FOR OPIOID USE
DISORDER.
NEXT SLIDE.
JUST A LITTLE BIT MORE OF AN
OVERVIEW OF "MORE," INTEGRATIVE
MIND-BODY THERAPY THAT UNITES
COMPLEMENTARY ASPECTS OF
MINDFULNESS TRAINING, CBT,
PRINCIPLES OF POSITIVE .
IT'S A SEQUENCED TREATMENT,
BEGINS WITH A FOUNDATION OF
MINDFULNESS, WHICH IS THE FORM
OF MEDITATION INVOLVING
NON-JUDGMENTAL PRESENT MOMENT
AWARENESS OF THOUGHTS, EMOTION,
BODY SENSATIONS.
AND THROUGH ITS EFFECTS ON
INCREASING ATTENTIONAL CONTROL,
META AWARENESS, MINDFULNESS IS
USED TO SYNERGIZE MORE ELABORATE
THERAPEUTIC TECHNIQUES LIKE
REAPPRAISAL, DESIGNED TO
MODULATE A SERIES OF THERAPEUTIC
MECHANISMS WHICH IN TURN ARE
INTENDED TO PRODUCE STEP-WISE
CHANGE IN A RANGE OF TREATMENT
TARGETS RELATIVE TO CHRONIC PAIN
AND OPIOID USE DISORDER.
AND JUST ALSO TO MENTION MORE
HAS BEEN FOUND TO BE EFFECTIVE
FOR ALCOHOL USE, OTHER ILLICIT
DRUGS, SMOKING, OBESITY,
INTERNET ADDICTION.
NEXT SLIDE.
IN TERMS OF SESSION
CONTENT,SESSIONS ARE TWO HOURS
LONGER, EXERCISE, DEBRIEFING,
EACH SESSION FOCUSES ON A
DIFFERENT TOPIC THAT BUILDS ON
EARLIER SESSIONS AND HERE IS AN
OVERVIEW OF TOPICS OF THE EIGHT
SESSIONS.
NEXT SLIDE.
NOW TO OUR STUDIES.
SO, WE CONDUCTED TWO STUDIES,
FIRST A SMALL PILOT STUDY
DETERMINED FEASIBILITY OF
IMPLEMENTING
MINDFULNESS-ORIENTED RECOVERY
ENHANCEMENT IN METHADONE
TREATMENT SETTINGS.
THIS STUDY INCLUDED 30 PEOPLE IN
METHADONE TREATMENT, RANDOMIZED
THEM TO MORE OR METHADONE
TREATMENT AS USUAL.
THIS STUDY WE IMPLEMENTED IN THE
METHADONE CLINICS AND
IMPLEMENTED THE INTERVENTION
FACE TO FACE, JUST WHEN WE WERE
ABOUT TO GET STARTED
IMPLEMENTING THE NEXT PHASE OF
THE STUDY THE LARGER STUDY,
COVID HIT.
I THINK ABOUT A WEEK OR SO
BEFORE WE WERE ABOUT TO GET
STARTED ON RECRUITMENT AND
IMPLEMENTING THE STUDY SO WE HAD
TO QUICKLY PIVOT AND WE
IMPLEMENTED THIS STUDY AND
INTERVENTION REMOTELY.
WE PROVIDED TABLETS TO THOSE
PARTICIPANTS IN THE STUDY SO
THEY COULD ACCESS THE TREATMENT
REMOTELY.
AND THEN WE RANDOMIZED 77
INDIVIDUALS TO METHADONE
TREATMENT AS USUAL, 77 TO THE
MORE INTERVENTION.
NEXT SLIDE.
BOTH STUDIES WERE IMPLEMENTED IN
COLLABORATION WITH METHADONE
CLINICS IN NEW JERSEY,
PARTICIPANTS WERE RECRUITED BY
REFERRALS FROM CLINIC STAFF,
FLYERS, AND IN-PATIENT WAITING
AREAS SO IN THE PILOT STUDY WE
WERE IN PATIENT WAITING ROOMS
FOR THE VIRTUAL STUDY WE WERE IN
PARKING LOTS APPROACHING PEOPLE
IN CARS SOMETIMES WHEN PEOPLE
WERE WAITING TO GET DOSED DURING
THE PANDEMIC.
WE RECRUITED PEOPLE IN COHORTS
OF 14, SINCE THE CLOSED GROUP
AND RANDOMIZED PEOPLE TO "MORE"
OR TREATMENT AS USUAL AT EACH
CLINIC, IN GENERAL TO BE
ELIGIBLE INDIVIDUALS HAD TO BE
ON METHADONE, PATIENTS IN THE
CLINIC EXPERIENCING CHRONIC
PAIN, AND BE ABLE TO PARTICIPATE
AND ATTEND THE INTERVENTION
SESSIONS.
NEXT SLIDE.
FOR ASSESSMENT WE CONDUCTED
SURVEYS AT BASELINE, 8 WEEKS
MEETLY POST-ASSESSMENT FOR THE
"MORE" GROUP AND 8 WEEKS AFTER
THAT, 16 WEEKS POST BASELINE.
WE ALSO COLLECTED ECOLOGICAL
MOMENTARY ASSESSMENTS, WHERE WE
PROVIDED PEOPLE WITH SMARTPHONES
DURING THE PILOT STUDY, THEY HAD
TABLETS DURING THE LARGER STUDY.
AND SO PEOPLE WERE
PROMPTED TWICE A DAY TO ANSWER
QUESTIONS ABOUT PAIN, CRAVING,
DRUG USE, IF THEY WERE IN THE
"MORE" GROUP WE ASKED ABOUT
THEIR MINDFULNESS PRACTICE, SO
IN DAILY ASSESSMENTS THROUGH
TEXT MESSAGES THROUGH THEIR CELL
PHONE OR THEIR TABLET.
SO THIS IS THE PATIENT --
PARTICIPANT CHARACTERISTICS.
THE CHARACTERISTICS WERE SIMILAR
IN BOTH STUDIES WITH SOME
VARIATION FOR THE SECOND STUDY
WE ADDED ANOTHER CLINIC.
SO RACIAL/ETHNIC DIVERSITY WAS A
LITTLE DIFFERENT.
BUT IN BOTH STUDIES AT LEAST
HALF WERE MINORITY POPULATION,
PARTICIPANTS ON AVERAGE MIDDLE
AGE, HALF WERE FEMALE.
AND AS YOU CAN SEE DRUG USE WAS
COMMON IN THE LAST 30 DAYS.
I THINK IN THE SECOND STUDY,
SMALLER PERCENTAGE WERE RECENTLY
USING SUBSTANCES BECAUSE WE DREW
FROM A BROADER POPULATION IN THE
CLINICS, FIRST STUDY MOSTLY FROM
THE INTENSIVE OUTPATIENT
PROGRAMS.
SO, THEY WERE MORE ACUTE, MORE
LIKELY TO BE USING, WE OPENED UP
TO BROADER PATIENT POPULATION.
SO -- ANOTHER THING I WANT TO
MENTION IS THAT THERE'S A LOT OF
TRAUMA IN THIS POPULATION, MORE
THAN HALF HAD EXPERIENCED
TRAUMATIC EXPERIENCE, AND ALMOST
THREE-QUARTERS EARNED LESS THAN
$30,000 A YEAR.
AND THE OTHER THING, NO
STATISTICALLY SIGNIFICANT
DIFFERENCES BETWEEN MORE AND
TREATMENT AS USUAL IN BASELINE
DEMOGRAPHIC VARIABLES IN THE R21
OR R33 STUDY.
THESE ARE RESULTS FROM THE PILOT
STUDY WHICH WE PUBLISHED IN THE
JOURNAL SUBSTANCE ABUSE
TREATMENT IN 2001.
NOT ONLY DID THE PILOT STUDY
SHOW MORE WAS FEASIBLE AND
ACCEPTABLE AS ADJUNCT TO
METHADONE TREATMENT,
PARTICIPANTS IN THE MORE GROUP
SHOWING FEWER DAYS OF DRUG USE
DURING THE STUDY AS COMPARED TO
TREATMENT AS USUAL AS SHOWN ON
THIS GRAPH.
ALSO IN THE PILOT STUDY WE FOUND
THAT MORE HAD SIGNIFICANTLY
BETTER PAIN-RELATED FUNCTIONING
AS SHOWN IN THE GRAPH HERE ON
THE RIGHT.
SIGNIFICANTLY LESS DEPRESSION
AND SIGNIFICANTLY LESS ANXIETY
AS COMPARED TO TREATMENT AS
USUAL OVER THE COURSE OF THE
STUDY.
NEXT SLIDE.
SO, GIVEN THE SUCCESS OF THE
R21, WE NEXT CONDUCTED OUR
LARGER STUDY IN 154 PEOPLE TO
SEE IF WE COULD REPLICATE
FINDINGS FROM THE R21 AND LARGR
STUDY, WE HAD TO IMPLEMENT THIS
VIRTUALLY BUT EVEN IMPLEMENTING
VIRTUALLY IN THIS LARGER STUDY
WE FOUND "MORE" RESULTED IN 36%
FEWER DAYS OF DRUG USE THAN
METHADONE TREATMENT AS USUAL.
AND SO WE SAY IN THIS SLIDE I'M
TALKING ABOUT OVERALL DRUG,
ILLICIT DRUG USE, OPIOID,
COCAINE, MARIJUANA,
METHAMPHETAMINE, A SPECIFIC
DIFFERENCE IN OPIOID USE AS
WELL.
NEXT SLIDE.
ANOTHER WAY TO LOOK AT THE DATA
WE FOUND THAT PARTICIPANTS IN
MORE ARE SIGNIFICANTLY LONGER
TIME TO DRUG USE OVER THE COURSE
OF THE 16 WEEKS THAN THOSE IN
TREATMENT AS USUAL.
NEXT SLIDE.
AND THIS IS SPECIFICALLY
ADDRESSING THE TARGET OF THE
BRIM INITIATIVE.
SO THE TARGET, FOCUS ON
ADHERENCE TO MEDICATIONS FOR
OPIOID USE DISORDER SO "MORE"
SIGNIFICANTLY INCREASE THE
METHADON ADHERENCE AT 16 WEEKS
COMPARED TO TREATMENT AS USUAL,
ADHERENCE MAINTAINED FROM
BASELINE TO 16 WEEKS AMONG THE
MORE GROUP BUT DECLINED IN
TREATMENT AS USUAL GROUP SO AT
16 WEEKS MORE HAD 4.4 TIMES THE
ODDS OF THOSE IN TREATMENT AS
USUAL TO HAVE A URINE DRUG
SCREEN POSITIVE FOR METHADONE,
AT 16 WEEKS, THAN AT BASELINE AS
COMPARED TO BASELINE.
NEXT SLIDE.
AND BASED ON OUR ECOLOGICAL
ASSESSMENT DATA, WE FOUND THAT
PATIENTS IN MORE HAD GREATER
DECREASE IN PAIN INTENSITY THAN
THOSE IN TREATMENT AS USUAL OVER
THE COURSE OF THE 16 WEEKS.
NEXT SLIDE.
AND WE HAD SIMILAR RESULTS WITH
DEPRESSION AND ANXIETY, THE MORE
GROUP EXPERIENCED SIGNIFICANTLY
GREATER REDUCTIONS IN DEPRESSION
THAN THE TREATMENT AS USUAL
GROUP.
THE MORE GROUP ALSO SEEMED TO
HAVE A GREATER DECREASE IN
ANXIETY BUT DIDN'T REACH
STATISTICAL SIGNIFICANCE IN THIS
SAMPLE.
NEXT SLIDE.
SO, WE'RE MOVING ON TO NOW
FIGURE OUT HOW WE CAN IMPLEMENT
THESE AND EXPAND OUR WORK FOR
MINDFULNESS-ORIENTED RECOVERY
AND ENHANCEMENT IN METHADONE
TREATMENT, WORKING ON TWO
STUDIES CURRENTLY.
ONE IS THE IMPLEMENTATION AND
EFFECTIVENESS OF MORE AS ADJUNCT
TO METHADONE TREATMENT AS PART
OF IMPOWR NETWORK WORKING TO
TRAIN CLINICIANS IN THE
METHADONE CLINIC, NOT JUST HAVE
RESEARCH THERAPISTS IMPLEMENTING
THE INTERVENTION.
IN A MUCH LARGER EFFECTIVENESS
STUDY AND TRYING TO EXPAND THE
FOCUS OF INTERVENTION.
ONE THING THAT HASN'T BEEN
ADDRESSED OFTEN IN DRUG
TREATMENT PROGRAM IS TOBACCO
DEPENDENCE TREATMENT.
WE WANT TO ADDRESS POLY
SUBSTANCE MUSE, MAKE SURE WE'RE
NOT JUST FOCUSING ON ILLICIT
DRUGS BUT ALCOHOL AND TOBACCO,
THAT ARE REPLACING IMPACTING
QUALITY OF LIFE.
AND SO WE'RE TRYING TO COMBINE
IT WITH OTHER INTERVENTIONS SUCH
AS MOTIVATIONAL INTERVIEWING TO
SEE IF THAT IMPROVES OUTCOMES IN
THIS POPULATION, AND ALSO
LOOKING TO FURTHER RESEARCH IN
ADDRESSING OPIOID MISUSE WITH
MINDFULNESS ORIENTED MEDICAL
VISITS TO TRANSLATE TO PREVENT
OPIOID MISUSE IN PRIMARY CARE
POPULATIONS.
NEXT SLIDE.
SO, TO CONCLUDE, BASED ON OUR
STUDIES SEEMS LIKE MORE IS AN
EFFICACIOUS INTERVENTION FOR
ADDRESSING SUBSTANCE USE,
PHYSICAL PAIN, EMOTIONAL PAIN,
MENTAL HEALTH AND IMPROVING
OVERALL METHADONE TREATMENT
OUTCOMES.
THAT'S IT.
SO ANY QUESTIONS?
>> GREAT.
SHOULD WE OPEN FOR DISCUSSION?
WE'VE GOT SEVERAL HANDS RAISED.
>> SO EXCITED ABOUT THIS.
I WANTED TO KNOW IF YOU THINK --
BUPRENORPHINE IS COMING UP AS AN
ALTERNATIVE FOR METHADONE,
THERE'S BEEN SOME TALK ABOUT
CLOSING DOWN METHADONE CLINICS
AND WHETHER OR NOT YOU THINK
THIS IS GOING TO BE SOMETHING
YOU'RE GOING TO HAVE TO THINK
ABOUT IN TERMS OF MOVING
FORWARD.
>> SO, IN TERMS OF THE EMPHASIS
BUPRENORPHINE OR METHADONE?
>>JUST YOUR TESTING IN
METHADONE TREATMENT PARADIGM,
RIGHT?
WHAT DO YOU THINK ABOUT THAT IN
VIEW OF BUPRENORPHINE BEING
INCREASINGLY POPULAR?
>> RIGHT.
SO I MEAN AT LEAST AROUND HERE,
IT DOESN'T SEEM LIKE METHADONE
TREATMENT IS GOING AWAY.
SO, BUT I THINK WE'RE WORKING TO
TRANSLATE INTO VARIOUS MODELS OF
TREATMENT.
I THINK MINDFULNESS
INTERVENTIONS ARE ALSO BEING
INVESTIGATED IN OUTPATIENT
SETTINGS SUCH AS WHERE
BUPRENORPHINE PRIMARY CARE
SETTINGS WHERE BUPRENORPHINE IS
PROVIDED, AND ACTUALLY I THINK
THE WORK THAT HAS ALREADY BEEN
DONE IN PRIMARY CARE SETTINGS
WITH "MORE" PREVENTING OPIOID
MISUSE CAN BE HELPFUL WITH
INCREASING ADHERENCE TO OTHER
OPIOID USE DISORDER MEDICATIONS
LIKE BUPRENORPHINE.
AND NALOXONE.
IT SIMPLY INCREASES AWARENESS
AND INCREASES CONSCIOUS CHOICE
AND DISCONNECTS THE HABITUAL
IMPULSIVE DECISIONS THAT OFTEN
LEAD TO LACK OF ADHERENCE OR
DRUG RELAPSE.
>> THANKS.
>> HI, DR. COOPERMAN.
REALLY AMAZING STUDY AND
RESULTS.
THIS IS DAN DICKERSON.
I WAS CURIOUS ABOUT THE
MINDFULNESS, SORRY IF I MISSED
IT, BUT CURIOUS HOW MANY
SESSIONS, HOW LONG WAS EACH
SESSION, WHICH MINDFULNESS
EXERCISES DID YOU USE?
>> SO, IT'S 8 WEEKS OF
INTERVENTION.
IT'S A 2-HOUR GROUP SESSION.
AND IT INCORPORATION THINGS LIKE
THE BODY SCAN, MINDFUL
BREATHING, MINDFUL SAVOR OF
POSITIVE EXPERIENCES, THAT'S THE
GENERAL OVERVIEW.
>> GREAT, THANKS.
>> YEAH, HI.
THIS IS ERICA SABINGA.
WONDERFUL WORK.
THANK YOU SO MUCH FOR IT.
TWO THINGS THAT COME UP FOR ME.
ONE IS I'M A PEDIATRICIAN, MORE
LIKELY TO WORK WITH CHILDREN OF
SUBSTANCE USING PARENTS.
ONE OF THE THINGS WE SEE IN
PEDIATRIC PRACTICE IS INCREDIBLE
APPRECIATION OF THE CHRONICITY
AND RELAPSING AND REMITTING
CHARACTERISTIC OF SUBSTANCE USE
DISORDER.
AS IMPRESSIVE AS 16 WEEKS IS, IT
IS NOT VERY LONG.
>>RIGHT.
>> IN THE COURSE OF A FAMILY'S
LIFE.
AND SO I WONDER IF YOU'RE, A,
THINKING ABOUT STUDYING THE
OUTCOMES FOR LONGER BECAUSE I
THINK IN MINDFULNESS RESEARCH
ONE OF THE THINGS THAT WE ARE
BEGINNING TO RECOGNIZE IS THE
UNFOLDING OF THE MENTAL HEALTH
IMPACT AND THE POTENTIAL FOR
BEHAVIORAL CHANGE, BUT THAT IT'S
AN EVOLUTION, THAT IT'S NOT A
SORT OF, YOU KNOW, THIS IS HOW
IT WORKS ON DAY 10 AND THAT'S
THAT, IF YOU KNOW WHAT I MEAN.
>> ABSOLUTELY.
>> I JUST WANTED TO SAY ONE
OTHER THING.
SORRY.
AND THEN YOU CAN TALK ABOUT
BOTH.
THE OTHER THING THAT I THINK IS
REALLY COMING UP IN MINDFULNESS
RESEARCH IS WHO IS DOING THE
MINDFULNESS INSTRUCTION, AND YOU
WERE TALKING ABOUT TRAINING
CLINICIANS TO DO IT.
AND I GUESS THAT RAISES A
DIFFERENT SET OF QUESTIONS ABOUT
THE FIT AND THEIR INTEREST IN
BECOMING MINDFULNESS
INSTRUCTORS.
AND WHAT WILL HAPPEN WITH THAT
WORK AS WELL.
THANK YOU.
>> BOTH VERY GOOD QUESTIONS.
WE'VE ASKED THOSE QUESTIONS AS
WELL.
SO, TO ADDRESS THE FIRST
QUESTION ABOUT LONG-TERM, SO IN
OUR STUDIES WE'RE WORKING ON
NOW, WE'RE PLANNING ON HAVING A
12-MONTH OR FULL-YEAR FOLLOW-UP,
SO WE'RE GOING TO FOLLOW PEOPLE
OVER THE 16 WEEKS WITH EMA BUT
WE'RE ALSO GOING TO CHECK IN 6
MONTHS AND ONE YEAR LATER.
AND TO ADDRESS YOUR QUESTION
ABOUT -- ALSO JUST TO REWIND A
MINUTE, ONE OF THE THINGS WE'VE
DISCUSSED IS, YOU KNOW,
MAINTAINING A MINDFULNESS
PRACTICE.
IN THE STUDY IMPLEMENTED NOW
WE'VE BEEN THINKING ABOUT WHAT
IS IT'S BEST WAY TO DO THIS TO
KEEP PEOPLE DOING THIS, TO TRAIN
PEOPLE TO DO THIS AND WHO IS
GOING TO DO THE INTERVENTION.
SO WE'RE LOOKING AT IT FROM
SEVERAL ANGLES.
ONE IS WE'RE TRAINING PEOPLE
TO -- THE CLINICIANS, AND WE'RE
INCORPORATING FOCUS GROUPS AND
ADVISORY BOARDS TO GET INPUT
FROM THE CLINICIANS AND FROM
PATIENTS IN THE CLINICS
THEMSELVES TO UNDERSTAND HOW
THIS CAN BEST BE INTEGRATED INTO
THE TREATMENT SETTING.
AND IT'S GOING TO BE A BACK AND
FORTH PROCESS OVER THE COURSE OF
THE STUDY.
WE'RE ALSO LOOKING TO COMPARE
THE FULL PACKAGE OF
MINDFULNESS-ORIENTED RECOVERY
ENHANCEMENT THAT DOES REQUIRE
TRAINING, A SIMPLE SCRIPTED
MINDFULNESS PRACTICE, WHERE
WE'RE NOT PROVIDING ANY TRAINING
AT ALL, WE'RE JUST GOING TO GIVE
A SCRIPT THAT CAN BE READ TO
GUIDE PATIENTS THROUGH
MINDFULNESS EXERCISES, TO SEE IF
THAT IS EQUALLY AS EFFECTIVE OR
STILL MORE EFFECTIVE THAN
TREATMENT AS USUAL, PERHAPS NOT
AS EFFECTIVE, SO THERE COULD BE
OPTIONS FOR IMPLEMENTING THIS.
AND DEPENDING ON THE RESOURCES
OF THE ENVIRONMENT AND SO WE
HAVE ALREADY FOR THE R33 DID
TRAIN ONE CLINICIAN, WE HAD ONE
AT EACH CLINIC TO SEE IF THEY
COULD LEARN IT WITH OUR RESEARCH
CLINICIAN.
AND TO KIND OF SIT IN ON THE
GROUPS AND CO-LEAD THEM, SO WE
WERE ABLE TO GET EVIDENCE OF
INTEREST AND ABILITY FOR THE
NEXT STUDIES.
YEAH, THAT'S ONE OF THE THINGS
WE'RE LOOKING TO EVALUATE IN OUR
UPCOMING WORK.
>> THANK YOU FOR THE GREAT
ANSWER AND ALL THIS WORK.
>> DR. JEAN-LOUIS ON THE ZOOM
MEETING.
>> I APPRECIATE THIS.
AS YOU KNOW, MINDFULNESS
INTERVENTION LEADS TO
IMPROVEMENT IN SLEEP DURATION
AND QUALITY.
I'M NOT SURE IF YOU MEASURED
THAT.
IF SO, WOULD THOSE PARAMETERS
SERVE AS A BUFFER TO BETTER
IMPROVING OUTCOMES?
>> THAT'S A VERY GOOD QUESTION.
SO, AS I'M TRYING TO REMEMBER,
THINK AS PART OF THE IMPOWR
STUDIES I THINK THERE ARE SLEEP
ASSESSMENTS IN THERE.
SO, WE ARE -- YOU KNOW, WE CAN
LOOK AT THAT IN OUR FUTURE WORK.
>> THIS IS GOOD.
THIS IS GOOD WORK.
>> YEAH.
>> SO, AGAIN, APPLAUDING THE
WORK AS EVERYONE ELSE IS, ALSO
GRATEFUL TO BE LEARNING OF THIS.
I'M CURIOUS, A LOT OF WHAT I'VE
HEARD AND LEARNED IN TERMS OF
THE RESEARCH AROUND WHAT IS
CONTRIBUTING TO THE OPIOID
ADDICTION EMPHASIZES LONELINESS,
DISCONNECTION, ALIENATION FROM
OTHER HUMAN BEINGS AS A
COMPONENT OF WHAT IS DRIVING THE
KIND OF, YOU KNOW, UP OF
EPIDEMIC IN SOME MEASURE IN SOME
PLACES.
WHEN I LOOK AT STUDY DESIGN
INCLUDING A GROUP SESSION
COMPONENT WHERE NECESSARILY
FOLKS ARE IN A GROUP, WONDERING
IF WHEN YOUR CONTROL, IF IT HAS
A GROUP COMPONENT, SO WE KNOW
THAT WE CAN ISOLATE THE EFFECT,
IS IT MINDFULNESS OR BEING IN
THAT GROUP FOR THAT PERIOD?
I'M JUST CURIOUS TO LOOK AT
THAT.
THE SECOND PIECE, RELATEDLY,
INTERPERSONAL MINDFULNESS
PRACTICES, I IMAGINE THEY MAY
ALSO BE INCLUDED.
YOU MENTIONED BREATHING
EXERCISE, BODY SCAN, MINDFULNESS
SAVORING OF PLEASANT EXPERIENCE,
I'M CURIOUS THE DEGREE
MINDFULNESS COMMUNICATION, AND
MINDFULNESSFUL PRACTICES THAT
ARE PART OF IT?
>> GREAT QUESTION.
JUST TO -- FIRST QUESTION ABOUT,
YOU KNOW, WHETHER IT'S JUST
BEING IN A GROUP SETTING, THAT
SEEMS LIKE A LOGICAL QUESTION.
SO, THE WORK THAT'S ALREADY BEEN
DONE ON MINDFULNESS ORIENTED
RECOVERY ENHANCEMENT HAS BEEN
COMPARED TO SUPPORT GROUP OF
EQUAL INTENSITY, AND TIME
INVESTMENT.
SO, THE RESEARCH THAT HAS BEEN
DONE IN SHOWING EVIDENCE MORE
FOR OPIOID MISUSE HAS BEEN
COMPARED TO A SUPPORT GROUP.
SO THAT WE KNOW THAT IT'S NOT,
YOU KNOW, IT'S AN ATTENTION
CONTROL AND THE SUPPORT IS THE
SAME.
WE ALSO LOOKED AT AN IN OUR
STUDY, LOOKED AT ADDITIONAL
GROUP AND INDIVIDUAL
PSYCHOTHERAPY TIME AND
TREATMENT.
WE ABSTRACTED IT FROM THE
PATIENT'S CHARTS AT THE CLINIC
AND DIDN'T FIND ANY SIGNIFICANT
DIFFERENCES IN ACTUAL
PSYCHOSOCIAL INTERVENTION
BETWEEN THE TREATMENT AS USUAL
AND MORE GROUPS.
SO A LOT OF THE INDIVIDUALS IN
THE TREATMENT AS USUAL GROUP
WERE ALSO GETTING GROUPS THROUGH
THE IOP PROGRAMS AT THE
METHADONE CLINIC.
IN A LOT IT REPLACED, SO THEY
DID HAVE EQUAL AMOUNT OF GROUPS.
MOVING FORWARD WE HAVE THAT
INTEGRATED INTO FUTURE STUDIES
SO THE ONE WHERE WE'RE
ADDRESSING TOBACCO DEPENDENCE
COMPARING IT TO A SUPPORT GROUP.
AND WE ALSO FOR THIS MINDFULNESS
PRACTICE WE'RE ALSO -- THAT'S A
GROUP AS COMPARED TO THE FULL
MINDFULNESS ORIENTED RECOVERY
ENHANCEMENT GROUP OF.
IN TERMS OF INTERPERSONAL
CONNECTION IN THE MORE GROUP
THERE'S A PROCESSING COMPONENT,
AND SUPPORT COMPONENT, THAT
IS -- THAT'S PART OF THE GROUP,
AND WE DO THE EXPERIENTIAL
EXERCISES BUT PROCESS TOGETHER
WHICH DOES I THINK IMPACT THAT
INTERPERSONAL HUMAN CONNECTION
PART.
>> IT'S A KIND OF INTERPERSONAL
MINDFULNESS PRACTICE THAT YOU'RE
PROCESSINGS BUT I WAS CURIOUS
ABOUT THE OTHER MORE TARGETED
INTERPERSONAL PRACTICES.
THANK YOU.
>> IT'S A GOOD POINT.
WE HAVEN'T -- I THINK IT'S SORT
OF APPLYING IT TO EVERYTHING IN
YOUR LIFE.
SO WE DON'T SPECIFICALLY TALK
ABOUT USING IT, I THINK IT
DEPENDS ON THE INDIVIDUAL.
SOMEONE COULD USE THAT IF THAT'S
WHAT'S APPROPRIATE FOR THEM THAT
THEY NEED TO GET HUMAN
CONNECTION, BUT IT'S NOT A
SPECIFIC TOPIC BUT THAT'S A GOOD
POINT.
>> THANK YOU.
>> YEAH.
>> DR. SHURTLEFF?
>> GREAT STUDY.
WE STARTED THE BRIM PROGRAM FIVE
YEARS AGO, THIS IS WHAT WE WERE
HOPING WOULD HAPPEN, SYNERGY
BETWEEN NON-PHARMACOLOGY
APPROACHES AND PHARMACOLOGY,
INTEGRATED APPROACH SO I'M
THRILLED BY YOUR RESULTS.
I GUESS MY QUESTION, IT WAS
WONDERFUL TO SEE ADHERENCE RATES
STAY PRETTY STABLE WITH THE MORE
GROUP.
DID THAT TRANSLATE TO OTHER
ASPECTS OF THEIR LIFE IN TERMS
OF JOB PERFORMANCE OR FAMILY,
GETTING BACK TO QUESTIONS DR.
SABINGA RAISED, WAS THERE ANY
CHANGE IN CRAVING, DID YOU DO
EMA AND SEE CRAVING SCORES
DIFFER BETWEEN THE GROUPS?
CURIOUS HOW THIS EXPANDS BEYOND
ADHERENCE.
>> ABSOLUTELY.
IN TERMS OF JOB PERFORMANCE,
OVERALL WELL-BEING, SO
SPECIFICALLY JOB PERFORMANCE, IT
WAS DURING COVID.
SO, YOU KNOW, IT'S HARD TO
UNDERSTAND, TO TEASE APART
WHAT'S WHAT IN TERMS OF THAT.
THERE WERE A LOT OF PEOPLE WHO
WERE UNEMPLOYED IN THE GROUP.
BUT WE DON'T HAVE SPECIFIC
MEASURES ABOUT THOSE KINDS OF
OUTCOMES.
WE DO HAVE WELL-BEING.
WE DO HAVE COPING SKILLS.
WHICH WE HAVEN'T ANALYZED,
WELL-BEING MEASURES FOR SURE.
WE LOOKED AT CRAVING.
WE'VE ANALYZED FROM THE PILOT
STUDY.
WE HAD INTERESTING FINDINGS WITH
THAT AND PUBLISHED A PAPER ON
THAT.
WE FOUND IN THE PILOT STUDY,
INDIVIDUALS REPORTED IN THE MORE
GROUP, REPORTED MORE --
EXPERIENCING MORE CRAVINGS, IN
OTHER WORDS THEY WERE MORE AWARE
OF THEM BUT ALSO MORE LIKELY TO
RESIST AND COPE WITH THEM
BETTER.
WE DID FIND THAT RELATIONSHIP IN
THE EMA DATA IN THE PILOT STUDY.
WE HAVEN'T TEASED APART ALL THE
CRAVING DATA YET IN THE R33,
YEAH.
>> GREAT.
WONDERFUL.
I WANT TO SEE IF THERE ARE
ADDITIONAL QUESTIONS FOR DR.
MORONE OR THE HEAL INITIATIVE IN
GENERAL, THERE ARE A FEW MINUTES
LEFT IF THERE ARE ANY QUESTIONS
ABOUT THE PROGRAM.
HOPEFULLY WE'VE GIVEN A GLIMPSE
OF THE ICEBERG, THERE'S A LOT
THERE.
A LOT OF PROGRAMS AND WE
CONTINUE HERE AT NCCIH TO PUT
FORWARD NEW CONCEPTS AND BRING
NEW IDEAS AND WE'RE GOING TO
TALK ABOUT CONCEPTS NEXT.
I DON'T THINK THEY ARE "HEAL"
THIS TIME AROUND.
I HAVE TWO CLOSING SLIDES.
DR. HANEY, DO YOU HAVE A
QUESTION?
>> VERY QUICKLY.
IS OUR TAKEAWAY THOUGH THAT
PEOPLE IN TREATMENT FOR
SUBSTANCE USE DISORDERS ARE
OPEN, MAJORITY ARE OPEN TO
MINDFULNESS?
IS THAT THE TAKEAWAY?
>> ACTUALLY, ABSOLUTELY.
I'VE DONE OTHER RESEARCH OF
OTHER BEHAVIORAL INTERVENTIONS
IN THE SAME CLINICS.
AND THERE WAS SOMETHING ABOUT
THIS INTERVENTION THAT -- A
NUMBER OF LEVELS.
PEOPLE WITHOUT UNDERSTANDING
WHAT IT WAS SAYING WE'RE GOING
TO ADDRESS YOUR PAIN IS REALLY
MOTIVATING.
THE FACT WE WERE GOING TO OFFER
SOMETHING TO HELP COPE WITH
PHYSICAL PAIN.
AND ONCE THEY BECAME INVOLVED IN
THE INTERVENTION, THEY SAID IT
WAS UNLIKE ANYTHING THEY
EXPERIENCED BEFORE IN TERMS OF
SUBSTANCE USE TREATMENT.
AND FOUND IT REALLY REWARDING.
WE HAD AMAZING RETENTION AND
PARTICIPATION IN THE GROUPS THAT
WERE DIFFERENT THAN ANY OF THE
OTHER STUDIES WE'VE DONE BEFORE.
SO, YEAH, IT'S INTERESTING.
IT'S DEFINITELY FEASIBLE.
THERE'S DEFINITELY BUY-IN FOR
THIS.
AND NOW WE'RE TRYING TO FIGURE
OUT, YOU KNOW, IN PERSON,
VIRTUAL, WHICH IS THE BEST WAY
TO DO THIS.
AND I SEE THAT THE QUESTION IS
ARE PROVIDERS OPEN TO IT.
AND WE -- AS THEY ARE SEEING
PATIENTS BENEFIT, THE CULTURE IN
CLINICS ARE EVOLVING, PATIENTS
ARE TALKING ABOUT IT, TALKING TO
THE PROVIDERS, CREATING BUY-IN
FROM THE PROVIDERS.
YEAH, THAT'S MORE OF WHAT WE'RE
GOING TO LEARN IN THE NEXT PHASE
OF THE RESEARCH.
>>FANTASTIC.
THANK YOU.
>>NINA, YOU'RE REMINDING ME OF
ONE OF THE SPEAKERS AT ONE OF
THE "HEAL" INVESTIGATORS
MEETINGS, TALKED ABOUT AT THEIR
TREATMENT FACILITY WHETHER THEY
WERE TREATING PATIENTS WITH
OPIOID USE DISORDER AND OTHER
ADDICTIONS THAT THEY WERE HAVING
SUCH A PROBLEM WITH STAFF
BURNOUT AND TURNOVER AND OTHER
THINGS THEY IMPLEMENTED A
MINDFULNESS BASED PROGRAM FOR
STAFF AND IT COMPLETELY
TRANSFORMED THEIR CLINIC.
SO I THINK THERE'S SOME
POTENTIALLY PROJECTS COMING
RELATED TO THOSE ACTIVITIES FOR
OPIOID USE DISORDER.
ONE OF THE BIG CHALLENGES IS
MAINTAINING ENOUGH PERSONNEL IN
MANY FACILITIES TO CONTINUE TO
PROVIDE TREATMENT.
SO I THINK THAT'S AN ONGOING
CHALLENGE AND SOMETHING THAT
MIGHT BE WORTH LOOKING AT.
>> WE INCORPORATE THAT INTO THE
TRAINING FOR THE CLINICIANS, THE
TRAINING OF THE INTERVENTION IS
EXPERIENTIAL, AND WITH THE
RECOMMENDATION THAT CLINICIANS
PRACTICE THEMSELVES.
SO THE IDEA IS TO KIND OF CHANGE
THE CULTURE TOWARDS A MINDFUL
CULTURE.
>> THAT'S GREAT.
TWO QUICK SLIDES, NEXT
DIRECTIONS.
I MENTIONED AT THE BEGINNING
THINGS ARE CHANGING, THE
PANDEMIC SORT OF WAS IN THE
MIDDLE OF THIS FIRST FIVE YEARS,
AND THE PATTERNS OF DRUG USE ARE
SHIFTING.
THERE'S LOTS OF NEW THREATS, I
DON'T KNOW IF PEOPLE HEARD ABOUT
XYLAZINE, OR TRANQ, MORE DEADLY
THAN FENTANYL, A COMBINATION.
THIS ISSUE OF POLY SUBSTANCE
USE, YOU'VE HEARD MENTIONED A
FEW TIMES, SOMETHING THAT "HEAL"
IS REALLY LOOKING AT ON THE
ADDICTION AND OVERDOSE SIDE.
ALSO, LOOKING AT HOW DO WE GET
REALTIME DATA SO WE CAN SEE
WHERE THERE'S A NEW CRISIS, A
NEW PROBLEM THAT'S OCCURRING IN
DIFFERENT AREAS, ADDRESSING THE
CO-OCCURRING MENTAL HEALTH
CONDITIONS, WE'VE HEARD ABOUT
SLEEP.
THERE'S TWO OR THREE PROGRAMS
WITHIN "HEAL" SPECIFICALLY
LOOKING AT THE OVERLAP BETWEEN
SLEEP AND OUD AND MENTAL HEALTH
CONDITIONS, TRYING TO TEASE THAT
OUT AND HOW THEY INTERACT WITH
ONE ANOTHER.
UNFORTUNATELY PAIN MANAGEMENT IS
STILL A BIT FRAGMENTS, SOMETHING
"HEAL" IS TRYING TO ADDRESS,
TRYING TO FIGURE OUT HOW DO WE
ENCOURAGE COORDINATED CARE,
RESEARCH, LOOKING AT THAT AND
WE'VE HEARD ALREADY TODAY A LOT
ABOUT HEALTH INEQUITIES, ROLE OF
SOCIAL DETERMINANTS IN GETTING
BOTH PAIN AND ADDICTION
TREATMENT.
NEXT SLIDE.
SO THESE ARE A COUPLE REALLY
FAST RESOURCES YOU CAN FIND OUT
INFORMATION.
I SEARCHED NIH HEAL INITIATIVE
AND ANY SEARCH ENGINE WILL GET
YOU THERE.
"HEAL" PUTS OUT FUNDING
OPPORTUNITIES EVERY YEAR AND
THEY TYPICALLY COME OUT IN THE
EARLY SUMMER TO EARLY FALL.
THE TOPICS ARE ALWAYS DIFFERENT.
THERE'S ALWAYS SOMETHING NEW
WE'RE LOOKING FOR.
BUT IT IS A GREAT PLACE TO TAKE
A LOOK AT.
I THINK WE'RE AT CLOSE TO $700
MILLION A YEAR IN BUDGET FOR
"HEAL," AND SO THERE ARE ALWAYS
NEW FUNDING ANNOUNCEMENTS AND
OPPORTUNITIES THAT DO COME OUT.
AND YOU CAN ALSO SEARCH FOR MORE
INFORMATION ABOUT ANY OF THE
FUNDED PROJECTS IN ALL OF THE
PROGRAMS ACROSS ALL OF "HEAL"
THROUGH THE FUNDED PROJECT
SEARCH.
THEY HAVE A NICE SEARCH ENGINE
YOU CAN SEARCH BY PROGRAM.
THANKS SO MUCH.
THANKS TO ALL THE PRESENTERS.
IT WAS FABULOUS.
>> OKAY.
SO, HOW ARE WE DOING?
EVERYBODY'S STILL HANGING IN
THERE?
OKAY.
>> MINDFULNESS!
>>YES.
OKAY.
WE HAVE ONE MAJOR ASPECT ON THE
AGENDA.
THIS IS OUR CONCEPT CLEARANCE,
COMING NEXT.
WE'RE HANGING IN FOR THE CONCEPT
CLEARANCE.
EVERYBODY WANTS TO LEAVE AS SOON
AS POSSIBLE.
CONCEPT CLEARANCE, OKAY.
LET'S START WITH CONCEPT
CLEARANCE.
FIRST ONE, OKAY.
EMRIN IS ALREADY UP THERE.
>> THANK YOU.
>> LET'S GET STARTED.
>> GOOD AFTERNOON.
TODAY WE WILL TALK ABOUT
CONCEPTS ABOUT THE WHOLE PERSON
RESEARCH INITIATIVE FOR NCCIH
ADVISORY CONCEPT APPROVAL.
NCCIH CURRENT STRATEGY PLAN
DEFINES WHOLE PERSON RESEARCH AS
INCLUDING THREE COMPONENTS.
FIRST, EXPLORING FUNDAMENTAL
SCIENCE OF INTERCONNECTED
SYSTEMS.
SECOND, INVESTIGATING
MULTI-COMPLEMENT INTERVENTIONS
OR THERAPEUTIC SYSTEMS.
THIRD, IMPACT OF THESE
INTERVENTIONS ON MULTI-SYSTEM OR
MULTI-ORGAN OUTCOMES.
NEXT SLIDE.
NEXT.
THE TIME IS RIGHT FOR WHOLE
PERSON RESEARCH DUE TO
CONVERGING ADVANCES INCLUDING
MULTIOMICS DATA, MEDICAL
INFORMATICS, ELECTRONIC HEALTH
RECORDS, MOBILE AND WEARABLE
TECHNOLOGIES, SOCIAL MEDIA AND
WEB DATA, AND MOVEMENT
PHENOTYPING, ALSO DIGITAL TOOLS
WHICH HAVE LAID THE GROUND WORK.
THE APPROACH CAN BUILD MODELS OF
MULTI-COMPONENT INTERVENTION BY
LINKING ACROSS PHYSIOLOGICAL,
BIOLOGICAL, AND ALSO BEHAVIORAL,
SOCIAL, ENVIRONMENTAL DOMAINS BY
LEVERAGING EXISTING DATA AND
COLLECTING NEW DYNAMICALLY
GENERATED DATA, AT MULTIPLE
TEMPORAL AND SPATIAL SCALES.
NEXT.
IN SEPTEMBER OF 2021 NCCIH
CONVENED A WHOLE PERSON RESEARCH
WORKSHOP ALONG WITH SEVERAL NIH
INSTITUTES AND CENTERS TO
DISCUSS RESEARCH EXAMPLES IN
WHOLE PERSON RESEARCH FROM
DIVERSE FIELDS.
AND DISCIPLINES.
ABOUT THESE THREE COMPONENTS.
IN ADDITION THE WORKSHOP
EXPLORED METHODOLOGIES
POTENTIALLY APPROPRIATE FOR
WHOLE PERSON RESEARCH, AND
SEVERAL TEAMS EMERGED.
FIRST, A SINGLE DISEASE,
CONDITION, OR BODY PARTS WILL
NOT BE SUFFICIENT TO SOLVE MAJOR
HEALTH PROBLEMS IN THE UNITED
STATES.
SECOND, SINGLE MODE INTERVENTION
IS OFTEN NOT ENOUGH FOR COMPLEX
HEALTH CONDITIONS.
THEREFORE REVEALING INSIGHTS
ABOUT MULTI-COMPONENT
INTERVENTION IMPACTING
MULTI-SYSTEM OUTCOMES WILL BE
CRITICAL, MORE INTEGRATIVE OF
UNDERSTANDING OF PATHOPHYSIOLOGY
AND DESIGN SEVERAL THERAPEUTIC
INTERVENTIONS AIMED AT WHOLE
PERSON IN THEIR ENVIRONMENTAL
CONTEXT.
NEXT SLIDE.
>> GREAT.
THIS NEW WHOLE PERSON RESEARCH
INITIATIVE WILL ADDRESS THE
DAUNTING HEALTH CARE CHALLENGE
BY STUDYING THE COMPLEX
INTERCONNECTED NATURE OF HEALTH.
AIMING TO CREATE DEDICATED
MULTI-DISCIPLINARY RESEARCH
PROGRAMS IN WHOLE PERSON
RESEARCH THAT WILL DEVELOP AND
TEST STATE-OF-THE-ART RESEARCH
MODELS THROUGH INNOVATEIVE
DESIGNS TO ANALYZE EFFECTS EVER
MULTI-COMPONENT INTERVENTION ON
INTERCONNECTED PHYSIOLOGICAL
SYSTEMS OF THE WHOLE PERSON WITH
DIVERSE SOCIAL AND ENVIRONMENTAL
CONTEXTS, THE SCOPE WILL INCLUDE
DEVELOPING AND TESTING MODELS
AND METHODS FOR BASIC,
MECHANISTIC, CLINICAL TRIAL AND
OBSERVATIONAL DATA RESEARCH
PROJECTS TO SUPPORT WHOLE PERSON
RESEARCH.
THE PROPOSED MULTI-DISCIPLINARY
RESEARCH PROGRAMS WILL PROVIDE A
STRONG AND MUCH NEEDED
FOUNDATION FOR WHOLE PERSON
HEALTH.
EXAMPLE ACTIVITIES MAY INCLUDE
BUILDING NETWORKS OF
RESEARCHERS, CREATING
OVERARCHING COORDINATING CENTER
THAT WOULD FACILITATE
COLLABORATION, SUPPORTING
DEMONSTRATION PROJECTS IN
PRE-CLINICAL MODELS OR HUMAN
SUBJECTS, SUPPORTING PILOT
PROJECTS, FEASIBILITY PROJECTS,
ALL THESE STUDIES WOULD BE AIMED
AT STUDYING INTERCONNECT THE
MULTIPLE SYSTEMS AND COMPLEX
MULTI-COMPONENT INTERVENTIONS
AND ULTIMATELY WE WOULD LOPE TO
SUPPORT SOME EFFICACY AND
EFFECTIVENESS TRIALS THAT WOULD
FOCUS ON THE WHOLE PERSON THAT
COULD BE BASED ON THE MODELS
THAT WERE BUILT THROUGH EARLIER
PHASES IN THE INITIATIVE.
NEXT SLIDE.
SO WE WOULD LIKE TO THANK YOU
FOR YOUR TIME AND ATTENTION AND
DO SEEK YOUR CONCURRENCE FOR
THIS PROPOSED CONCEPT.
WE WELCOME ANY QUESTIONS AND
COMMENTS YOU MAY HAVE.
THANK YOU.
>>I'LL ASK A QUESTION.
THIS WAS GREAT.
THANK YOU SO MUCH.
I'M CURIOUS IF YOU ANTICIPATE
THE STUDIES THAT WILL BE DONE AS
PART OF THIS INITIATIVE TO BE
INVOLVING BASIC AND MECHANISTIC
SCIENCE AND CLINICAL WORK OR
WOULD THOSE BE SEPARATE, WOULD
THOSE BE COMBINED, DO YOU HAVE
ANY THOUGHTS ABOUT THAT?
>>GREAT QUESTION.
THE ONE THING WE CAN SAY IS THAT
WE'RE HERE TOGETHER, I'M PART OF
THE CLINICAL RESEARCH BRANCH, MY
COLLEAGUE EMRIN IS IN OUR BASIC
MECHANISTIC BRANCH SO WE'RE
DELIBERATELY COLLABORATING FOR
THAT VERY REASON, A VERY
AMBITIOUS IDEA DEVELOPING WHOLE
PERSON INTERVENTIONS, LOOKING AT
THE WHOLE PERSON.
HOW DO YOU DO THIS IS SOMETHING
THAT'S GOING TO REQUIRE INPUT
FROM BOTH CLINICAL RESEARCHERS
AS WELL AS BASIC MECHANIC
MECHANISTIC
SCIENTIST, FIRST IS BRINGING
THIS TOGETHER TO PUZZLE IT OUT,
A BROAD RANGING SCOPE.
HOPEFULLY THAT HELPS.
>> YES, SO BY WHOLE PERSON, DO
YOU MEAN TO ADDRESS SYSTEMS THAT
ARE RESPONSIVE TO SINGLE
INTERVENTION OR HAVE
MULTI-COMPONENT INTERVENTIONS
TARGETING DIFFERENT SYSTEMS?
>> IT'S A GREAT QUESTION.
ACTUALLY WE COULD START WITH
WHAT IS THE IMPACT OF SINGLE
INTERVENTIONS ON MULTIPLE ORGAN
SYSTEMS BECAUSE WE STILL NEED
THE RICH INFORMATION IN THAT AND
USE SOME EXISTING DATA AND
DEVELOP METHODOLOGIES, AND THEN
OUR LAST AIM TO UNDERSTAND WHAT
IS THE MULTI-COMPONENT
INTERVENTION, WHAT ARE IMPACT OF
MULTI-COMPONENT INTERVENTION ON
SYSTEM OUTCOMES, IT WILL TAKE
TIME TO UNDERSTAND AND COMBINE
MULTIPLE INTERVENTIONS.
>> IF YOU'RE INTERESTED IN
THE -- VERY ROBUST DISCUSSION OF
THIS IN THE WORKSHOP THAT WAS
HELD IN 2021, AND THAT ENTIRE
WORKSHOP WAS ARCHIVED, YOU CAN
WATCH THE VIDEOS WHERE A LOT OF
THAT QUESTION WAS ADDRESSED.
WE DO HAVE MANY EXAMPLES OF
INVESTIGATORS IN THAT WORKSHOP
WHO TALKED ABOUT SINGLE
INTERVENTIONS THAT HAVE MULTIPLE
OUTCOME TARGETED IMPACTS, RIGHT?
AND THEN WE HAD SOME FOLKS WHO
WERE LOOKING AT MULTIPLE
INTERVENTIONS FOR SINGLE AND SO
ON AND SO FORTH SO THERE'S LOTS
OF EXISTING EXAMPLES BUT TO
REALLY PIECE IT TOGETHER I THINK
IS WHERE WE'RE TRYING TO HEAD IN
THE FUTURE.
>> I'D LIKE TO JUST MENTION I
DON'T KNOW IF IT CAME UP DURING
THE WORKSHOP, BUT SIMILAR
CONCEPT WAS USED BY NIMH IN OUR
ASSESSMENT OF DIFFERENT RESEARCH
DOMAINS ASSESSMENTS, LEVELS OF
ASSESSMENT OF THE INTERVENTIONS.
>> YES, ABSOLUTELY.
I'M FAMILIAR WITH RDoC.
THAT WAS A VERY GOOD
COMPREHENSIVE EXAMPLE.
>> ADDITIONALLY WE WANT TO
FIGURE OUT WHAT IS THE
COMPLEMENT INTERVENTION IN ORGAN
SYSTEMS, NOT JUST MULTIPLE
ORGANS.
>> THANK YOU.
>> I THINK THIS IS GREAT,
STRONGLY SUPPORTIVE OF THIS.
I THINK IT'S THE WAY, AS
PRACTITIONERS, WE DON'T DO JUST
ONE THING.
WE'RE ALWAYS USING
MULTI-COMPONENT INTERVENTIONS
TYPICALLY IN OUR PATIENTS.
NO MATTER WHAT WE'RE TREEING,
ACUTE OR CHRONIC ILLNESS.
IN SPORTS MEDICINE, THE CHURCH
OF WHAT'S HAPPENING NOW, THE
KITCHEN SINK GOES IN, WE HAVE TO
GET THIS BETTER AS QUICKLY AS WE
CAN SO WE'RE ALWAYS DOING
MULTI-COMPONENT INTERVENTIONS
AND SO I THINK THAT THIS IS
REALLY, REALLY EXCELLENT.
REALLY LOOKING FORWARD TO
PARTICIPATING IN THIS.
>> THANK YOU.
>> YES, THANK YOU SO MUCH.
I'M VERY SUPPORTIVE OF THIS
DIRECTION.
WITH NATIVE AMERICAN STUDIES I'M
ALWAYS FISHING AROUND FOR
DIFFERENT TYPES OF ASSESSMENTS,
MENTAL, PHYSICAL, SPIRITUAL,
WELL-BEINGS, AND HOW DO WE DO
THIS TYPE OF -- HOW DO WE
CAPTURE THESE DOMAINS OF HEALTH
WITHIN A SINGLE RESEARCH
PROJECT.
IT'S A BIG QUESTION.
I REALLY APPRECIATE THIS
ANNOUNCEMENT.
>> I THINK YOU MAY HAVE ALLUDED
TO IT A BIT BUT I'M CURIOUS IF
THE CONCEPTUALIZATION OF WHOLE
PERSON HEALTH AND ALL OF THE
WONDERFUL WAYS THAT THIS IS
FLOWERING INTO DIFFERENT
PROJECTS THAT ARE LINKING WITH
SYSTEMS AND IN MANY WAYS I THINK
ALREADY LEANING INTO WHAT I'M
GOING TO SAY, CURIOUS IF THERE'S
A KIND OF WHOLE COMMUNITY OR
SOME KIND OF COLLECTIVE
CONCEPTUALIZATION OF WHAT HEALTH
REQUIRES.
>> I LOVE THAT QUESTION.
SO, YOU KNOW, THE NIH IS REALLY
GOOD AT STUDYING BIOLOGY AND
BIOLOGICAL SYSTEMS, AND WE MANY
TIMES FALL SHORT ON THE MORE
COMMUNITY SIDE OF IT.
FORTUNATELY I COME FROM THAT
BACKGROUND SO I'M AN APPLIED
SOCIAL PSYCHOLOGIST BY TRAINING
SO I'M CERTAINLY BRINGING THAT
LENS TO THE TABLE AND HOPE TO
REALLY BUILD THE MODELS THAT
REALLY CAN BRING THAT TO BEAR
BECAUSE I THINK IT'S ONE OF THE
BIGGEST PREDICTORS OF HEALTH IN
THIS COUNTRY AT LEAST IS YOUR
ZIP CODE, RIGHT?
WHY IS THAT?
>> HEALTH AS AN ECOLOGY OF
HEALTH, RIGHT?
>> ABSOLUTELY.
YEAH, IF WE IGNORE THAT WE'D BE
REMISS.
>> PUSHING RESEARCH, THINK MORE
CREATIVELY MOVING BEYOND
INDIVIDUAL UNIT OF THE PERSON
UNIT OF MEASURE.
IT'S COMPLICATED BUT THAT'S
WHERE IT SEEMS HEADED, NEEDS TO
BE HEADED.
>> I CAN ALSO ADD WE HAVE A LOT
OF PARTNERS AT NIH, OTHER
INSTITUTES AND CENTERS, WE'RE
VERY EXCITED TO COLLABORATE.
ONE IS THE NATIONAL INSTITUTES
OF NURSING RESEARCH, THEY ARE
ALL OVER THIS.
THE OTHER ONE VERY INTERESTINGLY
IS NATIONAL INSTITUTES OF
ENVIRONMENTAL HEALTH RESEARCH,
AND THEY ARE VERY EXCITED ABOUT
THIS, EXTENDING THIS INTO THE
SOCIAL AND ENVIRONMENTAL
DOMAINS.
SO, WE'RE WORKING -- THESE ARE
TWO OF THE INSTITUTES, ALSO OF
COURSE NATIONAL INSTITUTES OF
MINORITY HEALTH AND HEALTH
DISPARITIES, THEY VERY
INTERESTED AS WELL.
WE HAVE A LOT OF PEOPLE WHO WANT
TO WORK WITH US ON THIS.
>> THANK YOU.
>> DO WE HAVE A MOTION A
APPROVING THIS CONCEPT?
>> SO MOVED.
>> OKAY.
SECOND?
>> SECOND.
>> OKAY.
SO PLEASE RAISE YOUR HAND IF
YOU'RE IN FAVOR OF THE MOTION.
THANK YOU.
MOTION HAS PASSED.
WE CAN MOVE TO THE SECOND
CONCEPT.
IT WILL BE PRESENTED BY DR.
PATRICK STILL.
>> GOOD AFTERNOON, COUNCIL
MEMBERS.
I'M PATRICK STILL, BASIC AND
MECHANISTIC BRANCH, NATURAL
PRODUCTS PORTFOLIO, PUTTING
FORWARD A STRATEGIC PLANNING
EFFORT FOR POTENTIAL 2025
INITIATIVE ON A RESOURCE CENTER
FOR CANNABIS AND CANNABINOID
RESEARCH.
I'LL START WITH BACKGROUND ON
THE PUBLIC HEALTH PERSPECTIVE,
AND PROGRESS OF NIH RESEARCH ON
CANNABIS AND MOVE TO PURPOSE OF
THE RESOURCE CENTER, WHICH MAPS
ONTO NEEDS IDENTIFIED AND
REQUESTS FOR INFORMATION.
AND THEN LASTLY LOOK AT
OBJECTIVES AND ACTIVITIES OF THE
CENTER.
NEXT SLIDE.
CANNABIS AND ITS CONSTITUENTS
HAVE BECOME A SIGNIFICANT PUBLIC
HEALTH TOPIC WITH 37 STATES
HAVING LEGALIZED MEDICAL AND
RECREATIONAL CANNABIS DESPITE
SHORT- AND LONG-TERM HEALTH
EFFECTS OF CANNABIS NOT BEING
ENTIRELY CLEAR.
THE CURRENT STATE OF EVIDENCE
AND RECOMMENDATIONS FOR RESEARCH
ARE SUMMARIZED IN THE 2017 NASM
REPORT ON HEALTH EEFFECTS.
LAST FIVE YEARS NIH PROGRESSED
IN ISSUING A VARIETY OF FUNDING
OPPORTUNITY ANNOUNCEMENTS SHOWN
HERE.
INVOLVING THIS RESEARCH THAT
THAT'S SUMMARIZE IN NIH-WIDE
CANNABIS AND CANNABINOID
RESEARCH FUNDING OPPORTUNITY
ANNOUNCEMENT WEB PAGE.
AND IN OCTOBER 2022, NCCIH
HOSTED AN ANNUAL PRINCIPAL
INVESTIGATORS MEETING WHERE
AWARDEES DISCUSSED THEIR ONGOING
RESEARCH AND CHALLENGES IN THE
FIELD.
NEXT CLICK.
NEXT SLIDE PLEASE.
THESE RESEARCH CHALLENGES IN THE
CANNABIS FIELD INTERSECT WITH
SEVERAL NIH INSTITUTES'
INTERESTS, AND TO DATE SEVERAL
NIH INSTITUTES HAVE TAKEN
EFFORTS TO LEVERAGE THE
THERAPEUTIC OPPORTUNITIES
ASSOCIATED WITH CANNABIS WITHIN
THEIR MISSIONS.
AND HAVE EXPRESSED INTEREST IN
JOINING THIS INITIATIVE AS
POTENTIAL PARTNERS.
NEXT SLIDE.
CHALLENGES DISCUSSED DURING THE
OCTOBER 2022 PRINCIPAL
INVESTIGATORS MEETING OVERLAPPED
WITH REQUEST FOR INFORMATION
ISSUED IN AUGUST OF 2022.
THE RESULTS OF WHICH ARE COLOR
CODED HERE, INTO SEVEN
CATEGORIES.
IT'S CLEAR FROM THE RESPONSES
THAT THE TOP NEEDS INCLUDE
INCREASED RESEARCH FUNDING,
INCREASED RESEARCH AND CLINICAL
GRADE PRODUCTS, PROMOTION OF
RESEARCH STANDARDS TOOLS,
METRICS, AS WELL AS PROVIDING
GUIDANCE ON REGULATORY
REQUIREMENTS.
NEXT SLIDE.
SO TO ADDRESS THE COMMUNITY
NEEDS FROM REQUESTS FOR
INFORMATION, PROPOSED CONCEPT
FOR RESOURCE CENTER FOR CANNABIS
AND CANNABINOID RESEARCH WILL
INCLUDE REGULATORY COMPLIANCE
CORE, WHERE ACTIONS SUCH AS
UPDATING REGULATORY GUIDANCE AND
BEING POLICY CLEARINGHOUSE FOR
RESEARCH OR GOALS COULD BE
ACCOMPLISHED.
REAGENTS, STANDARDS, AND
ANALYTICAL NEEDS COULD BE
ACCOMPLISHED THROUGH ANALYTICS
CORE SHOWN IN BLUE.
AND COMMUNITY NEEDS FOR PUBLIC
OUTREACH, TRAINING, AND SEED
FUNDING FOR REGULATORY
REQUIREMENTS AND PROPOSAL
DEVELOPMENT COULD BE
ACCOMPLISHED THROUGH AN OUTREACH
AND COMMUNITY SUPPORT CORE.
SO THESE CORE AREAS, GO BACK
ONE, THANK YOU, CORE AREAS AND
GENERAL OBJECTIVES WE ENVISION
AS BEING INTERCONNECTED,
ASSISTING PRINCIPAL
INVESTIGATORS AT EVERY CAREER
STAGE.
SO WE THEREFORE ASK FOR YOUR
CONCURRENCE ON THIS CONCEPT FOR
THIS PROPOSED INITIATIVE, ON A
RESOURCE CENTER FOR CANNABIS AND
CANNABINOID RESEARCH.
AND WE'RE HAPPY TO TAKE ANY
QUESTIONS YOU MAY HAVE.
THANK YOU.
>>THANKS, PATRICK.
THIS IS EXCITING.
I LIKE HOW I REACHED OUT FOR
FEEDBACK ABOUT GREATEST NEEDS
AND ARE TRYING TO MEET THOSE
NEEDS.
I HAD A COUPLE QUELLS. -- QUEST.
IS THAT LOW HIGH AND LOW THC,
HEMP AND MARIJUANA ARE TOPICS OF
RESEARCH?
>>YEAH, THE NIH LOOKED INTO
BOTH AREAS BUT DISTINGUISH THE
TWO.
>> RESOURCES FOR BOTH?
>> THAT'S RIGHT AND REGULATORY
GUIDANCE FOR SCHEDULE 1, IT
POINTS TO DIFFERENT ROUTES.
>> AND MY OTHER QUESTION IS
JUST TRYING TO UNDERSTAND WOULD
THIS BE SOMETHING THAT WOULD BE
BEING ACCOMPLISHED BY NIH OR
WOULD INVESTIGATORS BE
SUBMITTING PROPOSALS TO CREATE
THIS RESOURCE CENTER?
>> WELL, THAT'S A GREAT
QUESTION.
AND THIS RESOURCE CENTER IS
ENVISIONED AS HAVING A LOT OF
NIH OVERSIGHT.
HOWEVER, IT WILL BE LED BY THE
INVESTIGATIVE TEAM.
SO THE OUTREACH AND MEETING
SUPPORT, FOR EXAMPLE, WILL
REALLY BE LED BY THE COMMUNITY
SO THE IMPACT CAN BE INCREASED.
>> IT WOULD BE A U-GRANT KIND
OF CONTACT?
>>COOPERATIVE AGREEMENT
CONTEXT, YES.
>> AN RFA AND GROUPS WOULD
PROPOSE CREATING RESOURCE CENTER
DEPENDING ON EXPERTISE WITH NIH
INVOLVEMENT?
>> THAT'S RIGHT.
>> COOL, THANK YOU.
>> YEAH, THIS IS MY FIRST
COUNCIL MEETING.
THE ONLY THING I WANT TO SAY
SEEMS LIKE THE TWO CONCEPTS AND
THE OTHER ONE, THERE MUST HAVE
BEEN EXTENSIVE WORKSHOPS, KIND
OF LEADING UP TO THESE
PRESENTATIONS, SO IT'S VERY
HARD, THERE WAS A LOT OF
QUESTIONS HERE, IT'S DIFFICULT
TO APPRECIATE THE EXTENT OF IT
IN JUST, YOU KNOW, A FEW MINUTES
OF A PRESENTATION IN TERMS OF
ENDORSING OR NOT ENDORSING.
IT SOUNDS GREAT, BUT CLEARLY,
FOR EXAMPLE, EVEN THE PREVIOUS
ONE WILL NEED A LOT MORE WORK IN
AN RFA, I WOULD THINK?
>>THAT'S THE CHALLENGE WE FACE
BECAUSE WE DON'T WANT TO PROVIDE
SO MUCH INFORMATION THAT WE'RE
WRITING THE FOA, OR THE NOFO
NOW, NOTICE OF FUNDING
OPPORTUNITY, BEFORE IT'S
RELEASED BUT PROVIDE ENOUGH
INFORMATION ABOUT THE CONTEXT,
CONTEXTUAL FRAMEWORK SO AT LEAST
THE IDEA SOUNDS GOOD TO YOU THAT
WE'RE NOT GOING OFF IN A TOTALLY
TANGENTIAL WAY OR HITTING SOME
POSITIVE ASPECTS OF NEED IN THE
COMMUNITY OR FOR THE RESEARCH,
SO WE ALWAYS HAVE TO STRIKE THAT
BALANCE.
>> IF THERE WAS SOME MATERIAL
THAT I COULD HAVE LOOKED AT, YOU
KNOW.
>> OH.
>> MAYBE I DIDN'T LOOK ENOUGH.
I MEAN, THAT WOULD HAVE HELPED.
>> I SEE.
>> NOT ASKING ALL THESE
QUESTIONS.
I THINK THAT WOULD JUST BE
HELPFUL.
>> I HEAR WHAT YOU'RE SAYING,
MEASURE THAT'S SOMETHING WE
COULD DO IN THE FUTURE BUT WE'RE
HOPEFUL -- WE DON'T GIVE A LOT
OF INFORMATION BUT THE GENERAL
TOPIC, PRESENTING AN OUTLINE
THAT WILL LEAD TO WE HOPE, WE
THINK, CALL FOR PROPOSALS, DOES
THIS SEEM LIKE WE'RE IN THE
RIGHT BALL PARK, ARE WE DOING
SOMETHING THAT YOU THINK WILL
BENEFIT THE PUBLIC HEALTH,
RESEARCH COMMUNITY, ARE WE ON
TARGET?
SO WE'RE ASKING FOR 50,000-FOOT
PERSPECTIVE, IF THAT HELPS.
>> ALSO WOULD LIKE -- I CAN SEE
HOW PERHAPS -- YOUR COMMENT WAS
DIRECTED AT BOTH PROPOSALS BUT
CERTAINLY FOR THE ONE ON THE
WHOLE PERSON, THIS IS SOMETHING
THAT WE'VE BEEN WORKING ON NOW
FOR OVER THREE YEARS BECAUSE OF
IT'S DIRECTLY DERIVED FROM OUR
STRATEGIC PLAN.
SO IN A WAY, AS CLEARLY, WE
SHOULD HAVE THOUGHT MORE FOR NEW
COUNCIL MEMBERS WHO ARE ARRIVING
LIKE YOURSELF, SORT OF IN
RETROSPECT SHOULD HAVE PROVIDED
MORE BACKGROUND.
I CAN SEE HOW FROM WHERE YOU SIT
THAT WHOLE PERSON PROPOSAL MAY
HAVE SOUNDED VERY KIND OF BROAD
AND PERHAPS NOT VERY SPECIFIC,
RIGHT?
>> BUT VERY COOL TOO.
>> VERY COOL.
>> I UNDERSTAND IT BUT I THINK
--
>>YEAH.
IT'S A VERY -- IT'S A -- YEAH.
>> IT'S GETTING THE BALANCE
RIGHT.
I THINK WE DO ASSUME -- FOR NEW
COUNCIL MEMBERS IT'S HARD TO
JUMP INTO OF COURSE WE'RE DOING
BUT BOTH PROPOSALS IT'S BEEN A
LONG TIME COMING.
WE'VE HAD SEVERAL INITIATIVES,
RFAs, NOTICE OF SPECIAL
INTEREST, REACHED OUT TO THE
COMMUNITY TO DO A REQUEST FOR
INFORMATION.
WE'VE BEEN TO MEETINGS.
WE'VE TALKED TO INVESTIGATORS
WHO ARE FUNDED IN DOING CANNABIS
RESEARCH.
SO WE'RE GETTING A GOOD SENSE OF
THE PULSE OF THE COMMUNITY, WHAT
THE CHALLENGES ARE, AND
CERTAINLY THE PUBLIC HEALTH
NEED.
BUT NOW IT'S UP TO I THINK 38
STATES LEGALIZED MARIJUANA,
ADULT OR MEDICAL USE, AND WE
KNOW HISTORICALLY RESEARCH IS
FAR LAGGING BEHIND PUBLIC USE
AND INTEREST IN THIS PLAN, FOR
MARIJUANA SO WE'RE PLAYING
CATCH-UP AS A RESEARCH INSTITUTE
AND MANY RESEARCHERS ARE PUT OFF
BY THE REGULATORY CLIMATE THEY
ARE HAVING TO FACE, WE THOUGHT
THIS WOULD BE ONE WAY TO
FACILITATE THE WORK.
THAT'S THE GENERAL IDEA BEHIND
THIS AND THE DETAILS WOULD BE
FORTHCOMING, MORE WORK, MORE
DEVELOPMENT, THROUGH PRESUMABLY
A NOFO OF SOME SORT.
I DON'T KNOW IF THAT HELPS.
>> LET ME JUST ADD SOMETHING.
ALSO MENTION AT NCCIH WE'VE HAD
A CANNABINOID WORKING GROUP FOR
THE PAST COUPLE YEARS NOW THAT'S
EXTENDED TO TRANS-NIH WORKING
GROUP SO WE DO HAVE DEEP
DISCUSSIONS ABOUT THESE ISSUES
JUST LIKE THE WHOLE PERSON
RESEARCH.
I THINK WHAT'S PRESENTED HERE IS
THE 30,000-FOOT VIEW.
WE CAN'T GIVE YOU ALL THE
DETAILS BECAUSE IT'S AN OPEN
SESSION TO BEGIN WITH.
WE CAN'T WRITE THE FOA AND
DISCUSS IT OPEN.
IT'S THE CONCEPT.
>> I THINK I WANT TO THANK YOU
FOR BRINGING UP THIS CONCEPT,
PATRICK.
I HAVE SIMILAR QUESTIONS AS
WELL.
I THINK I'D LIKE TO SEE
SOMETHING THAT DOES LOOK AT
HEMP
AS WELL AS CANNABIS.
THERE'S A DISTINCTION BUT IT'S
NOT THAT GREAT.
WHATEVER IS USEFUL FOR CANNABIS
INDUSTRY COULD BE HELPFUL FOR
HEMP AS WELL.
ALSO THIS IS REALLY -- IT'S VERY
WELL THOUGHT OUT, RESOURCES ARE
EXACTLY WHAT YOU NEED TO STUDY
PLANT MATERIALS IN THIS WAY.
WITH THINGS LIKE PSILOCYBIN AND
SO ON COMING UP BEHIND SETTING A
PATTERN OR PIPELINE FOR HOW
THESE THINGS CAN BE APPROACHED
WOULD BE VERY HELPFUL.
>> RIGHT.
THANK YOU FOR THE SUPPORT.
>> DR. HANEY?
>> WELL, I CAN JUST QUICKLY ADD
THAT STUDY BE CANNABIS IS
UNBELIEVABLY DIFFICULT,
REGULATORY BURDEN IS INTENSE,
SCHEDULE 1 DRUG, SO EVEN THE
LOWEST POTENCY PRODUCT IS STILL
KEPT IN A GUN SAFE I GET INTO A
ROOM WITH A FINGERPRINT, TREATED
LIKE HEROIN.
FOGGY LATE FROM THE DAY, I'VE
TRIED TO GET FUNDING FROM NCI,
CANCER INSTITUTE BECAUSE
MAJORITY OF PATIENTS USE
CANNABIS AT SOME POINT IN THE
ILLNESS, NCI HAS FUNDED A SINGLE
STUDY TO MY KNOWLEDGE.
SO I GUESS I'M JUST NOT 100%
CLEAR ON WHAT YOUR INSTITUTE
WOULD DO IN COLLABORATION WITH
THE OTHER INSTITUTES.
SO I'M JUST FUZZY ON THE DETAILS
THERE SO WE DON'T HAVE PRODUCT
THE FDA APPROVES FOR THE POST
PART TO STUDY.
WE HAVE BARRIERS GETTING
PRODUCT.
DEA, FDA, YOU HAVE TO GET
APPROVAL, THERE'S A LOT OF
REGULATORY BARRIERS BUT I'M
FUZZY ON WHAT THIS WOULD DO.
GETTING RESOURCES FOR NEW
INVESTIGATORS IS HUGE BUT YOU
WOULD SUPPLY INFORMATION HOW TO
GET PRODUCTS TO STUDY OR -- I'M
SORRY, I'M GETTING FUZZY NOW.
>> THAT'S RIGHT.
AND THANKS FOR YOUR QUESTION.
THAT'S A GREAT COMMENT.
AND THIS RESOURCE CENTER ISN'T
ENVISIONED AS A RESEARCH
ANNOUNCEMENT.
IT'S TO PROVIDE, AS YOU
MENTIONED, RESOURCES FOR THE
COMMUNITY TO LOWER BARRIERS TO
ENTRY AND TO MOVE TO DIFFERENT
PARTS OF RESEARCH IF YOU'RE
ALREADY IN THE FIELD AND ENABLE
CONNECTIONS TO HIGH QUALITY
VENDORS, FOR EXAMPLE.
AND DETAILED PROCEDURES.
AND SO IT'S NOT A PARTICULAR
RESEARCH FOCUS.
IT'S MORE JUST TO PROVIDE
RESOURCES TO THE COMMUNITY TO
GET THE WORK DONE.
>> OKAY, GREAT.
THAT'S NIH-WIDE.
FOR ALL THE INSTITUTES
>>YEAH, UH-HUH.
>> THANK YOU.
>> TO YOUR POINT NCI HAD AN
RFI, IT'S NOW SOMETHING IN THE
ORDER OF 25% OF CANCER PATIENTS
USE CANNABIS, REQUEST FOR
PROPOSALS WAS TO INTERROGATE
EHRs TO LOOK FOR WHAT PATIENTS
ARE USING CANNABIS FOR AND YOU
CAN IMAGINE ONCE YOU HAVE THOSE
KINDS OF DATA, EPIDATA,
OBSERVATIONAL DATA COULD LEAD TO
MORE RESEARCH SO THEY ARE HE AT
THE BEGINNING OF THEIR INTEREST
IN IN CANNABIS.
WE HAD A MEETING WITH CDC THIS
WEEK.
NHLBI HOLDING A WORKSHOP
INTERNALLY IN THE NEXT FEW
MONTHS TO TALK ABOUT THEIR
PRIORITIES FOR CANNABIS RESEARCH
SO WHAT YOU'RE SEEING AS MORE
STATES LEGALIZE IT, CAN YOU
CONTINUE THE DRUM BEAT OF THIS
BEING A PUBLIC HEALTH ISSUE, THE
MORE NIH INSTITUTES ARE STARTING
TO TAKE NOTICE AND SET UP THE
RESEARCH PLANS.
WE SEE THIS COORDINATING CENTER
AS ONE PIECE TO THAT CHALLENGE
TO HELP FACILITATE THE WORK AS
IT COMES ONLINE AMONG THE
VARIOUS INSTITUTES AND CENTERS
AT THE NIH.
>> OKAY.
DO WE HAVE ANY MORE COMMENTS?
>> A GENERAL COMMENT BUT NOT
RELATED TO THIS.
IS THIS THE TIME TO DO IT?
>>I WANT TO CONGRATULATE THE
NCCIH THAT IT BECOMES LEADING IN
THIS RESEARCH ACROSS THE CENTER.
>> I SECOND THAT.
>> THANK YOU.
A QUICK COMMENT I WANTED TO ADD
TO THE PREVIOUS DISCUSSION,
THERE IS ALSO MORE INFORMATION
ON THOSE CONCEPTS ON THE
ELECTRONIC COUNCIL BOOK.
I ENCOURAGE YOU IF YOU DIDN'T
HAVE A CHANCE TO LOOK AT THIS
MATERIAL, JUST LOOK.
IF YOU STILL FEEL THIS IS NOT
ENOUGH INFORMATION, GET BACK TO
ME PLEASE.
AND THEN WE SEE WHAT WE CAN DO,
OKAY?
>> WE HEAR YOUR COMMENT
SERIOUSLY.
WE'LL PAY ATTENTION IN THE
FUTURE WHEN WE PRESENT CONCEPTS
THAT YOU THINK ABOUT WHAT
MATERIALS MIGHT BE HELPFUL, YOU
KNOW.
YEAH, YEAH.
>> THIS PROCESS REALLY LIVES ON
YOUR FEEDBACK.
WE NEED TO KNOW WHAT YOU NEED SO
YOU CAN PROVIDE THE ADVICE WE'RE
ASKING YOU FOR.
GOOD.
LET'S GO AND YEAH, THAT'S WHAT
I'M GETTING AT.
I HAVEN'T FORGOTTEN.
DO WE HAVE A MOTION?
OKAY.
SECOND?
YEP.
THANK YOU.
ALL IN FAVOR?
OKAY.
THE MOTION HAS PASSED.
SO WE'RE GETTING TO OUR NEXT
CONCEPT CLEARANCE.
THE THIRD ONE IS BEING PRESENTED
BY DR. HYE-SOOK KIM.
>> GOOD AFTERNOON, I'M PROGRAM
DIRECTOR AT NCCIH, I'M GOING TO
PRESENT A CONCEPT FOR YOUR
CONSIDERATION ENHANCING
MECHANISTIC RESEARCH OF
PRECISION PROBIOTIC THERAPIES.
PROBIOTICS ALSO KNOWN AS
MICROBIAL THERAPEUTICS, WHEN WE
ADMINISTER AT JUST RIGHT AMOUNT
IT WILL PROVIDE THERAPY TO HOST.
THESE ARE EXAMPLES OF POTENTIAL
BENEFITS, FOR EXAMPLE IT COULD
IMPROVE MENTAL HEALTH, METABOLIC
DISORDER, MODULATE OUR IMMUNE
SYSTEM.
THERE ARE BENEFICIAL EFFECTS,
ALSO UNDERLYING MECHANISM OF
ACTIONS DEMONSTRATED VERY WELL
FROM IN VITRO AND IN VIVO
STUDIES.
NEXT SLIDE.
HOWEVER, PRE-CLINICAL RESULTS
ARE NOT WELL TRANSLATED INTO THE
CLINICAL SETTINGS WHICH IS MAIN
CHALLENGE IN PROBIOTIC RESEARCH.
STUDIES FOUND VERY DIFFERENT
RESPONSE TO EXACT SAME PROBIOTIC
STRAIN IN INDIVIDUALS WHICH LED
SIGNIFICANT VARIABILITY IN
CLINICAL OUTCOMES.
THERE ARE MULTIPLE FACTORS
CONTRIBUTING TO THIS.
FIRST PROBIOTIC ITSELF, THEY ARE
THE LIVE MICROBES, HOW MANY LIVE
PROBIOTIC CELLS AND ALSO HOW
OFTEN WE TAKE THESE PROBIOTICS
COULD GIVE VERY DIFFERENT
OUTCOMES.
SECOND IS OUR GUT MICROBIOME.
WE HAVE QUITE DISTINCTIVE GUT
MICROBIOME WHICH CAUSE
RESPONSES.
HOST FACTORS SUCH AS AGE, DIET,
DRUG USE.
NEXT.
SO TOGETHER THESE -- GO BACK
ONE.
THANK YOU.
SO, ALL TOGETHER THESE INITIAL
CONDITIONS IN HOST AND
MICROBIOME COULD AFFECT OUTCOME.
ALSO HAMPER NOT ONLY VERY
EFFECTIVE EVALUATION OF THE
CLINICAL EFFICACY BUT ALSO
INTEGRATION AND IMPLEMENTATION
INTO CURRENT HEALTH CARE
SYSTEMS.
NEXT.
ONE SOLUTION TO TACKLE THIS IS
TO DEVELOP PROCEDURE AND
PROBIOTIC INTERVENTION PARADIGM
BECAUSE IT HAS CAPABILITY TO
PREDICT INTERINDIVIDUAL
VARIATION AND TAILOR PROBIOTIC
STRAINS TO INDIVIDUAL SPECIFIC
FEATURES.
NEXT.
HOWEVER, THIS APPROACH OF COURSE
NEEDS FUNDAMENTAL UNDERSTANDING
OF REAL LIFE VARIABILITY OF
PROBIOTIC RESPONSE AT INDIVIDUAL
LEVEL AS WELL AS DEVELOPMENT OF
RESEARCH TOOLS AND STRATEGY TO
ADDRESS THIS COMPLEXITY OF
PERSON-SPECIFIC CHARACTERISTICS.
NEXT.
SO TO IDENTIFY THE GAPS IN
CURRENT UNDERSTANDING AND ALSO
RESEARCH LITERATURE FOR
PRECISION PROBIOTIC TREATMENT
NCCIH AND OFFICE OF DIETARY
SUPPLEMENTS PLANNED AND HELD A
WORKSHOP ON PRECISION PROBIOTIC
THERAPY CHALLENGES AND
OPPORTUNITIES IN 2022 APRIL BY
COLLABORATING TEN NIH
INSTITUTES, CENTERS, OFFICE, AS
WELL AS USDA.
NEXT.
SO THIS WORKSHOP IDENTIFIES
SEVERAL RESEARCH PRIORITIES,
GAPS, AND OPPORTUNITIES.
THE FIRST IT WAS PARTICULARLY
REALIZED MOST OF THE PROBIOTIC
CLINICAL TRIALS DIDN'T FULLY
CAPTURE THOSE COMPLEX PATTERNS
OF GUT MICROBIOME, HOST
VARIABILITY, DIETARY
DIFFERENCES, ENVIRONMENTAL
EXPOSURES OF BOTH MICROBES AND
HOST IN THE STUDY DESIGN.
THESE ARE ALL AS I MENTIONED,
ALL VERY CRITICAL CONSIDERATIONS
FOR PRECISION AND PROBIOTIC
RESPONSE IN THE INDIVIDUAL
LEVEL.
AND SECOND, ALTHOUGH THERE HAS
BEEN SOME STUDIES LOOKING AT
SUCH COMPLEX PATTERNS, BUT ONLY
FEW OF INSIGHTS HAVE TRANSLATED
TO RIGOROUS MECHANISTIC STUDIES
TO TEST THE CAUSALITY AND ALSO
THE MECHANISTIC CLINICAL TRIALS
HAS NOT BEEN WELL TRANSLATED IN
THIS AREA.
THIRD, WE NEED ACTUALLY NEED
ADVANCED COMPUTATIONAL AND
ARTIFICIAL INTELLIGENCE APPROACH
THAT ALLOW US INTERROGATE
COMPLICATED RELATIONSHIP AMONG
MULTIPLE SYSTEMS WHEN WE DESIGN
AND CONDUCT PRECISION PROBIOTIC
STUDIES.
NEXT.
SO IN RESPONSE TO THIS WORKSHOP
WE LIKE TO PROPOSE ON INITIAL
CONCEPT TO SUPPORT HIGHLY
INNOVATIVE MECHANISTIC RESEARCH
TO DEVELOP PRECISION PROBIOTIC
INTERVENTIONS USING TWO-PHASE
APPROACH.
THE PHASE 1 WOULD BE
OBSERVATIONAL CLINICAL STUDIES,
SECONDARY DATA ANALYSIS STUDIES,
VERY INTERESTED IN PHASE 1 STUDY
THAT RIGOROUSLY ASSESS
MICROBIOME AND HOST BIOLOGY SO
WE CAN MAP THE PERSON-SPECIFIC
FACTORS.
AND STUDIES THAT DEVELOP
COMPUTATIONAL ANALYSIS AND AI
TOOLS TO DETERMINE CRITICAL
FACTORS THAT IDENTIFY PATIENT
SUBPOPULATION.
NEXT.
THE SECOND PHASE WILL OBVIOUSLY
UTILIZE THE DATA GATHERED FROM
THE PHASE 1, AND SECOND PHASE
WILL DESIGN RIGOROUS MECHANISTIC
STUDIES USING ANIMAL AND HUMAN
SUBJECT TO TEST THE CAUSALITY,
SO NEXT.
SO, THE HERE A FEW EXAMPLES OF
OUR INTEREST IN THE PHASE 2
STUDY.
WE LIKE INVESTIGATOR TO IDENTIFY
NOVEL BIOMARKERS THAT WILL BE
USED FOR DIAGNOSTIC AND ALSO
PROGNOSTIC PRECISION PROBIOTIC
TREATMENT AND LOOKING INTO
MECHANISMS OF ACTIONS AND
FACTORS THAT INTERFERE WITH
PROBIOTIC TREATMENT AND ALSO
WE'RE VERY INTERESTED IN
IDENTIFYING NEW TARGETS FOR
INTENDED PROBIOTIC EFFECT AS
WELL AS DEVELOPING NEW PROBIOTIC
STRAIN, MAYBE BETTER PROBIOTIC
STRAIN, AND DETERMINE DYNAMIC
MECHANISMS OF ACTION OF
PROBIOTIC INTERVENTION.
I ALSO SHOULD MENTION STUDIES
THAT ALREADY HAVE UNIQUE
PATTERNS OF THE RELATIONSHIP WAS
IDENTIFIED PURITY OF PROBIOTIC
STRAIN MAY BE SUPPORTIVE TO
PURSUE THE SECOND PHASE
DIRECTLY.
WITH THAT I WOULD LIKE TO THANK
YOU FOR YOUR ATTENTION.
THIS IS THE LAST ONE FOR THE DAY
AND I'M HAPPY TO TAKE YOUR
QUESTIONS.
>> THANK YOU FOR THIS
INITIATIVE, A WONDERFUL IDEA
BECAUSE WE ARE WHAT WE EAT.
ONE QUESTION I HAD REGARDING
PHASE 1, WHEN YOU'RE LOOKING AT
SPECIFIC INDIVIDUAL DIFFERENCES,
WILL IT TAKE A LONGITUDINAL
APPROACH, HOW FACTORS MAY
ACTUALLY CHANGE WITH TIME OR
JUST BASICALLY YOU'RE DOING IT
ONCE AND SAMPLING A POPULATION?
>> YEAH, THAT'S A VERY GOOD
QUESTION.
SO, WE'RE MORE INTERESTED IN
LONGITUDINAL SAMPLING SO WE CAN
FIGURE OUT PATTERNS INSTEAD OF
THE CAUSATION OF THE FEATURES
BECAUSE EVENTUALLY WILL BE VERY
IMPORTANT FACTORS THAT LINK TO
THE PROBIOTIC EFFICACY.
>> THANKS FOR THAT NICE
PRESENTATION.
YOU MENTIONED YOU'RE GOING TO BE
LOOKING AT THE MICROBIOTA AS
WELL AS HUMAN BIOLOGY.
WHAT ASPECTS OF HUMAN BIOLOGY DO
YOU PLAN TO LOOK THAT?
>> VERY GOOD QUESTION.
DIET, IMMUNE SYSTEM.
HOST GENOMES.
ALSO COULD BE DIFFERENT USE OF
THE MEDICATION AS WELL, BECAUSE
THOSE ARE ALL THE FACTORS THAT
TIGHTLY LINK TO THE RESPONSE TO
THE PROBIOTICS BECAUSE
PROBIOTICS GO TO THE GUT,
INFLUENCE GUT MICROBIOME AND
ALSO DIFFERENT PEOPLE HAVE
DIFFERENT TYPES OF MICROBIOME,
DIFFERENT IMMUNE SYSTEM, WE HAVE
TO IDENTIFY WHICH MAY BE MOST
EFFECTIVE FOR CERTAIN PROBIOTICS
SO WE CAN TAILOR DESIGN.
>> I'VE HAD THIS DISCUSSION
WITH MANY MICROBIOME
RESEARCHERS, THEY CAN'T SAY WHAT
IS THE GOLD STANDARD MICROBIOME.
VARY GREATLY BY CERTAINLY
DETERMINANTS OF HEALTH, REGIONAL
DIETARY REFERENCES.
HOW ARE YOU GOING TO LEVERAGE
DATA AND ESTABLISH WHAT'S
NORMAL, HEALTHY.
>> WE ARE NOT LOOKING FOR
NORMAL AND NOT HEALTHY
MICROBIOME BECAUSE WHILE WE'RE
LOOKING IN THE PHASE 1 STUDY,
OTHER MICROBIOME FACTORS THAT
MIGHT LINK TO EFFECT OF THE
PROBIOTIC, SO ALTHOUGH THE
PROBIOTIC WOULD BE STIMULATION
OF THE Th1, IMMUNE SYSTEM, AND
STUDY DESIGN, PHASE 1 WILL BE
LOOKING AT OTHER FACTORS OTHER
THAN IMMUNE RESPONSE, MAYBE THE
MICROBIOME, DIFFERENT PERSON
MICROBIOME COULD AFFECT
INFLUENCE TO THE PROBIOTIC AND
THEN EXPRESSION OF THE IMMUNE
MODULATION SO WE'RE LOOKING FOR
THE FACTORS, MICROBIOME PROFILE
THAT LINK TO EFFECT OF INTENDED
USE OF THE PROBIOTICS, IT'S NOT
LIKE WE TRY TO DEFINE WHAT IS
THE HEALTHY MICROBIOME, SO THAT
IS NOT TO MY KNOWLEDGE THAT'S
ALMOST IMPOSSIBLE AT THIS
MOMENT.
>> WHAT ABOUT INTERACTIONS WITH
DIFFERENT PHENOTYPES OF DIETS?
WHAT KIND OF DIETS WILL YOU USE?
IS THAT ONE OF THE KEY PATTERNS?
>>YEAH, THAT'S EXACTLY WE LIKE
TO SEE, HOW THE DIFFERENT DIETS
WILL CHANGE THE RESPONSE TO THE
PROBIOTICS.
THAT'S ONE OF THE KEY FACTORS
THAT WE LIKE TO SEE AND WE LIKE
TO RECORD AND USING MAYBE
HOPEFULLY DEVELOP COMPUTATIONAL
AND A.I. TOOL TO MAP AND TEASE
APART AND THEN FIND WHAT IS THE
BEST PROBIOTIC STRAINS FOR THAT
SPECIFIC INDIVIDUALS, DIFFERENT
TYPES ALSO OF TAKING DIFFERENT
TYPES OF THE DIETS INTO THE
CONSIDERATION.
>> OKAY.
ANY MORE COMMENTS?
QUESTIONS?
NO?
>> THANK YOU.
>> THEN DO WE HAVE A MOTION?
>> SO MOVED.
>> THANK YOU.
SECOND?
OKAY.
THEN PLEASE RAISE YOUR HAND IF
YOU ARE IN FAVOR FOR THE MOTION.
THE MOTION HAS PASSED.
OKAY.
WE'RE GETTING TOWARDS THE END OF
THE MEETING.
ONE THING, DR. LANGEVIN
MENTIONED NEXT COUNCIL
MEETING -- CAN YOU HEAR ME?
I NEED TO GET CLOSER.
NEXT COUNCIL MEETING WILL BE
HELD ON SEPTEMBER 8, AND I THINK
ALL OF YOU HAVE RECEIVED A
CALENDAR INVITE SO IT SHOULD BE
ON YOUR CALENDARS.
AND THE LAST AGENDA ITEM FOR THE
OPEN SESSION IS GENERALLY PUBLIC
COMMENT SESSION, SINCE MEMBERS
OF THE PUBLIC ARE ATTENDING
VIRTUALLY IT'S NOT POSSIBLE TO
MAKE IN-PERSON COMMENTS.
THEREFORE ANYONE WHO WISHES TO
MAKE A PUBLIC COMMENT MAY DO SO
BY SENDING ME YOUR WRITTEN
COMMENTS WITHIN 15 DAYS OF THE
CONCLUSION OF THIS MEETING.
THIS CAN BE DONE EITHER VIA
E-MAIL OR HARD COPY LETTER.
SHOULD BE LESS THAN 700 WORDS IN
LENGTH, CONSIST WENT A
FIVE-MINUTE ORAL PRESENTATION,
AND ACTUALLY IT'S CORRECT, YEAH.
YOUR WRITTEN COMMENT WILL BE
PROVIDED TO COUNCIL VIA THE
ELECTRONIC COUNCIL BOOK.
NOW, THIS TIME AROUND, WE
RECEIVED A PUBLIC COMMENT AHEAD
OF THE MEETING.
THE -- IT PROPOSES THAT THE
SPIRITUAL COMPONENT OF HEALTHS
BE INCORPORATED INTO THE
FRAMEWORK FOR WHOLE PERSON
HEALTH AS A SEPARATE DOMAIN.
WE'VE SHARED THE COMMENT WITH
OUR COUNCIL MEMBERS, WE
DISCUSSED IT THIS MORNING.
AND WE WILL CONTINUE DISCUSSING
THIS AT NCCIH AS WE DO RECOGNIZE
THE IMPORTANCE OF SPIRITUALTY
FOR WHOLE PERSON HEALTH.
I JUST WANTED TO POINT THAT OUT.
ANOTHER COMMENT TO THIS IS ALSO
THAT WE REALIZE THAT SENDING
PUBLIC COMMENTS UNTIL TWO WEEKS
AFTER THE MEETING IS NOT A VERY
SATISFYING PROCESS.
SO, WE'RE LOOKING INTO THIS TO
CHANGE THE PROCESS.
AND WITH THIS I'M NOT
ACTUALLY -- SOMETHING ELSE TO
SAY?
WE'RE PROBABLY FINISHED.
AS WE'RE GETTING REALLY TO THE
END OF THIS COUNCIL MEETING I
WOULD LIKE TO STATE WHAT A
PLEASURE IT HAS BEEN TO MEET SO
MANY OF YOU IN PERSON, IN MANY
CASES I KNOW YOU FOR LIKE MANY
YEARS, IT'S THE FIRST TIME I
HAVE SEEN YOU AND YOU'VE BEEN IN
A ROOM WITH ME HERE TODAY FOR
THE COUNCIL MEETING.
I SAY THANK YOU FOR BEING HERE
TODAY.
I WOULD LIKE TO THANK COUNCIL
MEMBERS FOR ATTENDING.
NCCIH WOULD NOT BE ABLE TO
FULFILL ITS MISSION WITHOUT YOUR
EXPERTISE, FEEDBACK AND
GUIDANCE.
THANK YOU SO MUCH FOR JOINING US
TODAY AND FOR OFFERING YOUR
ADVICE.
I WOULD ALSO LIKE TO OFFER MY
SINCEREST THANKS TO ALL OF NIH
STAFF.
THIS WAS A VERY BUSY COUNCIL RUN
FOR NCCIH.
YOU COULD PROBABLY TELL FROM THE
NUMBER OF INITIATIVES PRESENTED
AND NUMBER OF CONCEPT CLEARANCES
YOU HEARD, THIS MEANS STAFF WAS
VERY BUSY TO GET TO THIS POINT,
TO GET INITIATIVES DEVELOPED AND
PUBLISHED, TO GET THEM REVIEWED,
YOU KNOW, GRANTS MANAGEMENT IS
NOW WORKING HARD WITH THE
PROGRAM OFFICERS TO GET ALL THE
GRANTS OUT OF THE DOOR.
ALSO AS I HAVE MENTIONED BEFORE
THIS IS OUR FIRST IN-PERSON
MEETING SINCE THE PANDEMIC
STARTED, AND I HAVE TO HONESTLY
ADMIT I HAVE COMPLETELY
FORGOTTEN HOW MUCH WORK GOES
INTO ORGANIZING AN IN-PERSON
MEETING.
SO IMMENSELY GRATEFUL TO OUR
ADMINISTRATIVE I.T. SUPPORT
STAFF, OFFICE OF COMMUNICATION,
WITHOUT THEIR HELP AND
DEDICATION WE WOULD NOT HAVE
BEEN ABLE TO HAVE THIS MEETING
HERE TODAY.
WITH THIS, I'M HANDING IT OVER
TO DR. LANGEVIN FOR CONCLUDING
REMARKS.
>> WELL, I'M GOING TO START BY
CONGRATULATING MARTINA BECAUSE
MARTINA BEING RELATIVELY, YOU
KNOW, NEW IN HER ROLE HAS NOT
HESITATED WHEN WE MADE THE
DECISION TO HOLD THIS MEETING,
WE ONLY HAD ONE PRIOR MEETING,
YOU KNOW, WITH MARTINA IN THE
CHAIR.
WHICH WAS NOT IN PERSON.
AND NOW WE WENT AND TOOK THE
PLUNGE AND DECIDED TO DO IT.
I CAN SAY YOU DID EVERYTHING
WITH FLYING COLORS.
I WANT TO REALLY THANK MARTINE.
AND OF COURSE I TOTALLY AGREE
WITH ALL OF HER COMMENTS ABOUT
HOW HARD THE STAFF HAS WORKED.
WE'RE VERY, VERY PLEASED HOW
THIS WENT TODAY.
AND I WANT TO ALSO OF COURSE
THANK ALL OF YOU COUNCIL
MEMBERS, INCLUDING THE -- WE HAD
SO MANY NEW MEMBERS, AND SO IT'S
GREAT TO SEE YOU.
IT'S REALLY -- I REALLY HOPE IN
SEPTEMBER EVEN MORE OF YOU CAN
COME IN PERSON, AND I HOPE WE
CAN HAVE, AGAIN, A SOCIAL
GATHERING SO WE CAN GET TO
REALLY, YOU KNOW, SEE AS MANY AS
POSSIBLE WITH YOU SO YOU GET TO
KNOW EACH OTHER, AND SO I CAN
ONLY SAY THANK YOU SO, SO MUCH.
YOU'VE PROVIDED US WITH JUST
VERY FRANK AND VERY HELPFUL
FEEDBACK, AND WE'LL TAKE IT ALL
TO HEART.
SO YOU REALLY HELP US GOING
FORWARD.
SO THANK YOU.
>> I DECLARE THE 84th MEETING
OF THE COUNCIL CLOSED.