137th Meeting Minutes

Minutes – February 9, 2021

The National Advisory Council on Drug Abuse convened its 137th meeting at 10:45 a.m. on February 9, 2021. This meeting was conducted virtually. The closed portion of the meeting held on February 9th was for reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion, which was open to the public, began at 1:15 p.m. and was also video cast. The Council adjourned on February 9, 2021 at 4:18 p.m.

Council Members Present
Linda Chang, M.D.
Gail D'Onofrio, M.D., M.S.
Lakshmi Devi, Ph.D.
Daniel Goonan
Christian Heidbreder, Ph.D.
Paul Kenny, Ph.D.
Kenneth Mackie, M.D.
Jessica Hulsey Nickel
Sharon Walsh, Ph.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present:
Regina Carelli, Ph.D. – University of North Carolina
Tom Freeman, Ph.D. – University of Bath
Valentina Lorenzetti, Ph.D. – Australian Catholic University
Rosalie Pacula, Ph.D. – University of Southern California
John Carnevale, Ph.D. – Carnevale Associates
Alan Budney, Ph.D. – Dartmouth
Ryan Vandrey, Ph.D. – Johns Hopkins University
Gillian Schauer, Ph.D, M.P.H. – University of Washington, CDC

During the Open Session of Council, 235 participants joined live via videocast.

Closed Portion of the Meeting – February 9, 2021

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.

   Dr. Susan Weiss, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   Drs. Elena Koustova, Kurt Rasmussen, Rita Valentino, Carlos Blanco, and Albert Avila Directors of NIDA’s Office of Translational Initiatives and Program Innovations, Division of Therapeutics and Medical Consequences, Division of Neuroscience and Behavior, Division of Epidemiology, Services and Prevention Research, and Deputy Director of the Office of Research Training Diversity, and Disparities presented their Division’s/Office’s assigned and peer reviewed applications for consideration by the Council. For each application, Council provided unanimous en bloc concurrence with the initial scientific review. Five Special Council Review applications and four foreign applications were presented to Council for review, and Council concurred with program assessments. The initial review of all Trans-NIH Initiatives, including NIH Common Fund, Blueprint, and BRAIN applications as well as foreign applications and applications with a secondary assignment to NIDA also received Council concurrence.

   Council and staff were recused from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications for which there was a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave the room if an application in conflict with that member was acted upon en bloc.

3. Report to Council from the Board of Scientific Counselors
   
   Dr. Amy Newman, the Scientific Director of the NIDA Intramural Research Program (IRP) introduced Council to role of the Board of Scientific Counselors (BSC). The chair of the BSC, Dr. Regina Carelli provided an overview to Council on the most recent BSC review of the IRP

Open Portion of the Meeting

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed all attendees. She reminded all in attendance that the meeting was open to the public in compliance with the Government in the Sunshine Act, was available and recorded via videocast, and indicated that any public comments can be submitted via email within 10 days of the meeting would be included in the minutes.

   She then called attention to future Council meeting dates: May 11, 2021, (NACDA) May 12, 2021 (CRAN), and September 15, 2021.

2. Consideration of the Minutes of Council

   The Minutes of the September 2020 NIDA Advisory Council were unanimously approved as written.

3. Review of Council Operating Procedures
   
   Dr. Susan Weiss, Executive Secretary of NACDA, reviewed the updates to the Council Operating Procedures and Council unanimously approved the changes.

4. NIDA Director’s Report(NIH Videocast @ 0:04:00) – Nora Volkow, M.D., Director, NIDA

   Dr. Nora Volkow began by introducing Amy Newman as the new Scientific Director for NIDA’s IRP program and reviewed NIDA’s budget for FY2021. She then gave an overview of the “Monitoring the Future Study” 2020 Survey Results and discussed trends among U.S. teenagers for nicotine and marijuana vaping as well as alcohol use. Next, Dr. Volkow acknowledged the expansion of marijuana legalization at the state level, but from a scientific perspective, the outcomes and consequences are unknown. To investigate this, the Adolescent Brain Cognitive DevelopmentSM Study (ABCD Study®) seeks to understand the consequences of marijuana use on the developing brain in teens. She then provided updates on the ABCD Study® and the adaptations needed due to COVID. Dr. Volkow also discussed the Healthy Brain Cognitive Development study which will examine brain development from the prenatal period to early childhood and allow for the study of opioid and other drug exposure in pregnancy on development. Both studies will allow for unique research related to the effects of COVID-19. Dr. Volkow then discussed the adverse effects of the pandemic on those with substance use disorders (SUDs) and reviewed a study that showed individuals with any SUD had higher rates of COVID-19 compared to those without SUDs. She also highlighted drug trends with stimulants, fentanyl, and methamphetamine and the need for effective treatments. Dr. Volkow then presented data on the adverse effect of the pandemic of researchers and academic institutions, particularly related to career trajectory, mental health, and research productivity. She ended her presentation by emphasizing the need for more health disparities research and increased diversity in the scientific workforce.

   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 58:34).

5. Standardized Unit of measure of Cannabis Research (NIH Videocast @ 1:24:30) – Susan Weiss, Ph.D., Director, Division of Extramural Research: and Emily Einstein, Ph.D., Chief, Science Policy Branch, Office of Science Policy and Communication

   Dr. Susan Weiss briefed Council on NIDA’s past efforts and continuing conversations regarding the development of a standard unit of measure for cannabis research. Similar to morphine milligram equivalent and alcohol stand drink sizes, cannabis research would benefit from a standardized unit by improving the quality of measurement in clinical studies and if adopted more broadly, could create a more informed consumer choice. Dr. Weiss noted the caveats including route of administration, product variation, and complex pharmacokinetics of cannabis. A few years ago, the Cannabis Policy Research Group began this discussion and suggested to Council the possibility of constructing a standardized dose. Initial discussions in a journal article suggested a 5 mg dose and Dr. Volkow agreed a standard unit would be useful and followed up with a paper and a request for information which yielded largely supportive responses. NIDA continued the discussion with several experts and debated the benefits and risks of establishing a 5 mg vs. 10 mg standard unit. When a final decision is reached, NIDA intends to inform the research community that the THC standard unit should be used in NIDA research where applicable and will work with regulators and stakeholders to adopt this approach within the state authorized marijuana markets. Dr. Weiss then introduced the expert consultants that have participated in these discussions thus far to join the discussion with Council.

   Following the presentation, a discussion with Council and Workgroup members occurred (NIH Videocast @ 1:35:12).

6. NIDA Meetings Report (NIH Videocast @ 2:09)
   
   Social Determinants of Opioid Use: Establishing a Research Agenda to Inform community and System Level Interventions – Aria Crump, Sc.D, Deputy Chief, Prevention Research Branch, DESPR
   
   Dr. Aria Crump provided an overview of the goals and outcomes of the September 9, 2020 Social Determinants of Opioid Use meeting. The meeting consisted of a diverse group of community-engaged scholars, practitioners, and health officials to discuss the role of social determinants in the emergence and persistence of disparities in opioid misuse. The meeting identified research gaps and priorities and discussed strategies to prevent opioid misuse and improve other drug use outcomes.
   
   Adolescent Brain Cognitive Development Study Principle Investigators Meeting – Gaya Dowling, Ph.D., Direct, ABCD Study; and Steve Grant, Ph.D., Health Scientist Administrator, DNB

   Dr. Gaya Dowling first provided an update on progress in the ABCD Study during the COVID-19 pandemic including their switch to virtual assessments and flexibility with scheduling imaging and sensitive assessments in-person. She then discussed the new research being conducted to assess the impact of COVID-19 including additional questionnaires, collecting extended FitBit data to examine activity, sleep, and heart rate, and mapping variation in the community with questionnaire data to explore questions such as social distancing behaviors, effects of unemployment, and impact of local/state policies. Researchers will continue to study the effects of the pandemic on the study participants. Dr. Steve Grant then presented on new ABCD Imaging Tools and Resources including GWAS discovery using MOSTest, proving tissue microstructure using Restriction Spectrum Imaging (RSI), and the multi-spectral brain atlas.

7. Concept Clearances (NIH Videocast @ 2:33:52)

   Division of Therapeutics and Medical Consequences (DTMC)
   • Medications Development Initiative – David McCann, Ph.D., Associate Director
   • Abuse Liability Testing Initiative – David McCann, Ph.D., Associate Director
   • Drug Supply Program – Rik Kline, Ph.D., Chief, Chemistry and Pharmaceutics Branch

   Council voted to approve the first three contract concepts
   • Developing digital therapeutics for substance use disorders – Will Aklin, Ph.D., Heath Scientist Administrator

   Division of Epidemiology, Services, and Prevention Research (DESPR)
   • Population Assessment of Tobacco and Health (PATH) Study – Heather Kimmel, Ph.D., Health Scientist Administrator
   
   Council voted to approve the PATH contract concept
   
   Division of Extramural Research (DER)
   • Accelerating the Pace of Child Health Research Using Existing Data from the Adolescent Brain Cognitive Development (ABCD) Study – Elizabeth Hoffman, Ph.D., Scientific Program Manager, ABCD Study
   
   Office of Translational Initiatives and Program Innovations (OTIPI)
   • Mobile Health Solutions to rectify digital inequality in communities affected by drug addiction – Leonardo Angelone, Deputy Director
   • Advancing Pharmacotherapeutics for Substance Use Disorders (SUD): Focus on pre-clinical development – Ram Arudchandran, Ph.D., Health Scientist Administrator
   • Leveraging Artificial Intelligence (AI) tools for Substance Use Disorders (SUD) drug discovery and development – Ram Arudchandran, Ph.D., Health Scientist Administrator

   Division of Neuroscience and Behavior (DNB)
   • Genetic analysis of non-human animal models to understand the genomic architecture of substance use disorders and addictive behaviors – Amy Lossie, Ph.D., Health Scientist Administrator
   • Imaging- Science Track Award for Research Transition – John Fedota, Ph.D., Health Scientist Administrator

8. Public Comments (NIH Videocast @ 2:57:40)
   No public comments were submitted. 
9. Adjourn (NIH Videocast @ 3:00) 
   The 137th meeting of the National Advisory Council on Drug Abuse was adjourned at 4:18 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

• Nora D. Volkow, M.D.
  Director, NIDA
  Chair
  National Advisory Council on Drug Abuse
• Susan Weiss, Ph.D.
  Executive Secretary
  National Advisory Council on Drug Abuse

Council Roster

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.