136th Meeting Minutes

Minutes – September 10, 2020

The National Advisory Council on Drug Abuse convened its 136th meeting at 11:00 a.m. on September 10, 2020. This meeting was conducted virtually. The closed portion of the meeting held on September 10th 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 12:45 p.m. and was also video cast. The Council adjourned on September 10, 2020 at 4:16 p.m.

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

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

During the Open Session of Council, 193 participants joined live via the videocast.

Closed Portion of the Meeting – September 10, 2020

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. Kurt Rasmussen, Rita Valentino, Carlos Blanco, and Elena Koustova, Directors of NIDA’s Division of Therapeutics and Medical Consequences, Division of Neuroscience and Behavior, Division of Epidemiology, Services and Prevention Research, and Office of Translational Initiatives and Program Innovations, 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. Ten Special Council Review applications, three MERIT awards, two foreign applications, and one Administrative Supplement 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.

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: February 9, 2021, May 11, 2021, (NACDA) May 12, 2021 (CRAN), September 15, 2021.

2. Consideration of the Minutes of Council

   The Minutes of the May 2020 NIDA Advisory Council and May 2020 CRAN meeting were unanimously approved as written.

3. NIDA Director’s Report (NIH Videocast @ 0:02:50) — Nora Volkow, M.D., Director, NIDA

   Dr. Volkow first introduced organizational and leadership changes within NIDA and the current and projected budgets for FY 2021. She then discussed trans-NIH COVID-19 efforts that include novel technologies for screening and testing, public-private partnerships for therapeutics, and research on vulnerable populations to name a few. Specific to NIDA, Dr. Volkow provided updates on the Adolescent Brain Cognitive DevelopmentSM Study (ABCD Study®) related to COVID-19 and the opportunity for investigators outside the study to use the data collected in their own research. She highlighted one published study looking at effects of lead exposure on cognition and brain structure moderated by socioeconomics. Next, she presented data from the 2019 NIDA-funded “Monitoring the Future Study” which shows increases in teenager and college-aged vaping of nicotine and tetrahydrocannabinol (THC) and overall increases in overdose deaths, particularly in synthetic opioids. Current data collected during the COVID-19 pandemic shows an increase in drug use and Dr. Volkow discussed how the HEALing Communities Study and the Justice Community Opioid Innovation Network (JCOIN) are actively responding to these increases. In addition, the US has seen several policy changes as a result of COVID-19 increasing access to prescription medications for Opioid Use Disorder. She also acknowledged the existing health disparities in overdose deaths, particularly with cocaine and methamphetamine use, and the current lack of effective medications to treat stimulant use disorder. Lastly, Dr. Volkow provided updates on the NIDA Strategic Plan and the NIDA Initiative to Promote Racial Equity.

   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 1:00:27). 

4. Points to Consider Updates (NIH Videocast @ 1:21:28) — Susan Weiss, Ph.D., Director, Division of Extramural Research

   Dr. Susan Weiss presented the recommended modification to NIDA’s Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants document. Over the past few months, a working group consisting of NIH staff and outside experts proposed modifications to the document aimed at addressing potential conflicts of interest extending from non-paid positions and tobacco company advisory boards as well as potential conflicts of interest with foundations that receive funds from the tobacco industry. The workgroup also proposed modifications in light of increased use of nicotine vaping products in adolescents by recognizing that there is insufficient data on electronic nicotine delivery systems (ENDS) potential utility, but the increased use in teens is a concern. Research on ENDS should be done independently from outside influence and free from any real or apparent conflict of interest. As noted in the Points to Consider document, NIDA will consider a grantee’s funding and consulting relationships when making funding decisions regarding applicants who also receive tobacco industry funding. Council voted to move forward with the recommended changes and the updated document will be posted on the NIDA website.

5. Racial Equity Action Plan (NIH Videocast @ 1:28:05) — Gaya Dowling, Ph.D. and Emily Einstein, Ph.D., Racial Equity Co-Leads

   Drs. Dowling and Einstein introduced the NIDA Initiative to Promote Racial Equity. Dr. Volkow launched this initiative to address racial inequity in the NIDA workplace, in the NIDA funded workforce, and in the NIDA research portfolio. They detailed the structure of the initiative and mission statements of each subgroup. For each subgroup, they discussed upcoming and future activities including surveys, listening sessions, portfolio analyses, and scientific meetings. Dr. Dowling concluded by sharing a tentative timeline for the Racial Equity Initiative.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 1:46:30).

6. Division of Epidemiology, Services and Prevention Research Updates (NIH Videocast @ 1:53:30) – Carlos Blanco, M.D., Ph.D., Director, Division of Epidemiology, Services and Prevention Research

   Dr. Blanco provided updates on the current and future work of the Division of Epidemiology, Services and Prevention Research (DESPR). He first introduced the overall goals of the division to improve our understanding of substance use disorder (SUD) and increase the adoption of treatment and prevention interventions. This is achieved through the interconnected work of the three branches: Prevention Research, Services Research, and Epidemiology Research. He then detailed the priorities of each branch such as reducing health disparities and addressing structural factors contributing to SUD in the Epidemiology Research Branch, addressing social dynamics and improving the translation to practice pipeline in the Services Research Branch, and research to test novel targets and improving adoption and implementation in the Prevention Research Branch. Dr. Blanco also discussed large projects in the Division including the Monitoring the Future Study, the Population Assessment of Tobacco and Health (PATH) study, and Justice Community Opioid Innovation Network (JCOIN). He concluded by mentioning the need for better data collection and access to data, the need to better utilize the United States Preventive Services Task Force (USPSTF) for prevention, and creating new working standards in light of COVID-19.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:16:45). 

7. BRAIN Initiative Updates (NIH Videocast @ 2:19:25) – John Ngai, Ph.D., Director, BRAIN Initiative

   Dr. Ngai first introduced the team involved in supporting the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative at NIH and the major findings of the 2019 Brain Working Group 2.0. In addition to continuing to support technology development and brain circuitry research, the group also put emphasis on researching behavior paradigms, subcortical structures, and model organisms and also to encourage both team science and individual-investigator research. Dr. Ngai presented transformative projects including the brain cell census, mapping brain connectivity, and technologies for cell type-specific access. He then discussed the relevance of the BRAIN Initiative to the NIDA mission, specifically how understanding the molecules, cells and circuits in pain and reward behaviors will be critical to finding new strategies to treat and prevent addiction.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:51:55). 

8. Concept Clearances (NIH Videocast @ 3:05:53)

   Division of Therapeutics and Medical Consequences (DTMC)
   • In Vitro Metabolism and Non-Clinical ADME Studies – Jason Sousa, Ph.D., Health Scientist Administrato
   • Translational Avant-Garde – Iván Montoya, M.D., M.P.H., Deputy Director

   Division of Neuroscience and Behavior (DNB)
   • Exploratory Studies to Understand Mechanisms of HIV Infection, Replication, Latency, and/or Pathogenesis (including HAND) in the Context of Substance Use and Substance Use Disorders (SUDs) – John Satterlee, Ph.D., Health Scientist Administrator
   • High-throughput Discovery and Validation of Novel Signal Transducers or Small Molecules that Modulate Opioid and other Substance Use Disorder-Relevant Pathways – John Satterlee, Ph.D., Health Scientist Administrator
   • Tools and Technologies to Explore Brain Biomolecular Condensates (BMCs) – John Satterlee, Ph.D., Health Scientist Administrator
   • Mechanistic Studies on the Impact of Social Inequality – Vani Pariyadath, Ph.D., Branch Chief
   • Sleep Disruption and the Impact on Substance Use Trajectory – Steve Grant, Ph.D., Health Scientist Administrator
   
   Office of Translational Initiatives and Program Innovations (OTIPI)
   • Growing Great Ideas: Research Education Course in Product Development and Entrepreneurship for Life Science Researchers – Elena Koustova, Ph.D., M.B.A., Director, OTIPI

   Division of Epidemiology, Services, and Prevention Research (DESPR)
   • Managing Comorbid Chronic Pain and OUD – Shelley Su, Ph.D., Health Scientist Administrator

   AIDS Research Program (ARP)
   • Advancing Exceptional Research on HIV/AIDS and Substance Abuse – Vasundhara Varthakavi, D.V.M., Ph.D., Associate Director
   • HIV/AIDS High Priority Drug Abuse Research – Vasundhara Varthakavi, D.V.M., Ph.D., Associate Director
   • Coordinating Center for the HIV/AIDS and Substance Use Cohorts Program – Vasundhara Varthakavi, D.V.M., Ph.D., Associate Director

9. Public Comments (NIH Videocast @ 3:26:37)
   No public comments were submitted. 
10. Adjourn (NIH Videocast@ 3:27:05) 
    The 135th meeting of the National Advisory Council on Drug Abuse was adjourned at 4:03 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.