139th Meeting Minutes

Minutes – September 15, 2021

The National Advisory Council on Drug Abuse convened its 139th meeting at 11:00 a.m. on September 15, 2021. This meeting was conducted virtually. The closed portion of the meeting held on September 15th primarily reviewed applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion of the meeting, which was open to the public, began at 12:45 p.m. and was also provided by Videocast. The Council adjourned on September 15, 2021 at 4:36 p.m.

Council Members Present
Gail D'Onofrio, M.D., M.S.
Carlos del Rio, M.D.
Lakshmi Devi, Ph.D.
Daniel Goonan
Dennis Deer, Ph.D.
Travis Rieder, Ph.D.
Andrey Ostrovsky, M.D.
Melissa Walls, Ph.D.
Shelly Greenfield, M.D., M.P.H.
Rajita Sinha, Ph.D.
Christian Heidbreder, Ph.D.
Jessica Hulsey Nickel
Sharon Walsh, Ph.D.
Rajita Sinha, Ph.D.
Christian Heidbreder, Ph.D.
Jessica Hulsey Nickel
Sharon Walsh, Ph.D.

Ad Hoc Council Members Present
None

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present:
None

During the Open Session of Council, 236 participants joined live via videocast.

Closed Portion of the Meeting – September 15, 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. Albert Avila (Deputy Director), Carlos Blanco (Director), Elena Koustova (Director), Jane Acri (Acting Deputy Director), and Rita Valentino (Director) of NIDA’s Office of Research Training Diversity, and Disparities, Division of Epidemiology, Services and Prevention Research, Office of Translational Initiatives and Program Innovations, Division of Therapeutics and Medical Consequences, and Division of Neuroscience and Behavior 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. Three administrative supplements, two MERIT applications, one MERIT extension, and 12 applications for Special Council Review were presented to Council, and Council concurred with program assessments and recommendations. 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. In total, Council concurred with the initial review of 1,835 applications, totaling $163,847,603 in direct costs.

   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 8, 2022, May 10, 2022 (NACDA), and May 11, 2022 (CRAN), September 13, 2022, February 8, 2023, May 8, 2023 (NACDA), May 9, 2023 (CRAN), September 12, 2023.

2. Council Rotations
   Dr. Volkow welcomed new members to NACDA: Dennis Deer, Ph.D., Travis Rieder, Ph.D., Andre Ostrovsky, M.D., Rajita Sinha, Ph.D., Shelly Greenfield, M.D., M.P.H. (introduced at NIH Videocast @ 2:01:39) and Melissa Walls, Ph.D.

3. Consideration of the Minutes of Council

   The Minutes of the May 2021 NIDA Advisory Council were unanimously approved as written.

4. NIDA Director’s Report (NIH Videocast @ 0:06:22) – Nora Volkow, M.D., Director, NIDA

   Dr. Nora Volkow began by reviewing NIDA’s budget for FY2021 including HEAL and non-HEAL research. She provided an update on NIDA’s COVID-19 initiatives. She then reviewed data on drug use in college-age adults, drug-involved overdose deaths, buprenorphine treatment results. Dr. Volkow provided an update on medication development for opioid use disorder (OUD) and opioid overdose (OOD). She then highlighted progress made by the Adolescent Brain Cognitive DevelopmentSM Study (ABCD Study®) and accomplishments of the HEALthy Brain and Child Development (HBCD study). Next, Dr. Volkow presented the 2021 HIV/AIDS Research Avenir Award recipients. She followed this with a presentation of data on COVID mortality disparities for patients with substance use disorder (SUD). Dr. Volkow concluded with an update on NIDA’s Racial Equity Initiative. 

   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 0:49:34). 

5. NIDA AIDS Research Program Name Change (NIH Videocast @ 1:22:19) – Redonna Chandler, Ph.D.

   Dr. Chandler serves as the Director of NIDA’s AIDS Research Program.

   Dr. Chandler presented a justification to change the name of the “AIDS Research Program” to the “HIV Research Program” to accurately reflect the research and to use non-stigmatizing language. This action would not require outside approval and will not impact funding or limit research. The NIH Office of AIDS Research has been notified and NIDA is seeking Council’s input on this change.

   Following the presentation, a discussion with Council members occurred (NIH Videocast @ 1:26:38).

6. Updates from the Center for Clinical Trials Network (NIH Videocast @ 1:30:06) – Betty Tai, Ph.D.

   Dr. Tai is the Director of the Center for Clinical Trials Network (CCTN) and presented updates from the CCTN and the National Drug Abuse Treatment Clinical Trials Network (CTN) research portfolio.

   Dr. Tai provided an overview of the NIDA’s CTN and budget. She provided details about the research portfolio and the Nodes (i.e., research hubs and sites). Dr. Tai described projects related to the Helping to End Addiction Long-termSM Initiative (NIH HEAL Initiative M) and the impact of COVID-19 on the network’s activities. She outlined the study timelines, the large multi-site trials, the emergency department research, and the early detection/prevention research. Dr. Tai also presented the non-HEAL portfolio including timelines and described the stimulant research portfolio, co-morbid infectious diseases research, health disparities research and other studies. She presented on the CTN’s workforce development, publications, and dissemination. Dr. Tai reviewed potential research gaps and concluded with acknowledgements of involved NIDA staff.

   Following the presentation, a discussion with Council and Workgroup members occurred (NIH Videocast @ 2:00:57).

7. NIDA Data Science: Where We Are and Where We’re Going (NIH Videocast @ 2:04:16) – Susan Wright, Ph.D.
   
   Dr. Wright is the Program Director and NIDA Coordinator for big data and computational science.

   Dr. Wright described how big data and Artificial Intelligence (AI) could be used to lead to novel discoveries and improve public health. She presented NIDA’s vision for maximizing the value of biomedical data across data science themes: Data Infrastructure, Data Ecosystem, Tools and Analytics, Community Engagement and Workforce Development. She continued with how NIDA’s vision would integrate with the BRAIN Initiative, the HEAL initiative, and NIH Common Fund – Bridge2AI. Dr. Wright described activities with other agencies: Collaborative Research in Computational Neuroscience (CRCNS), Interagency Modeling and Analysis Group (IMAG), and NDF-NIH Smart and Connected Health Initiative. She concluded by describing the outreach activities.

   Following the presentation, a discussion with Council and Workgroup members occurred (NIH Videocast @ 2:27:49).

8. Concept Clearances  (NIH Videocast @ 2:40:05)   

   Division of Epidemiology, Services, and Prevention Research (DESPR)
   — Reaching Equity at the Intersection of HIV and Substance Use: Novel Approaches to Address HIV Related Health Disparities in Minority Populations - Sheba Dunston, Ed.D., MPH, CHES Social Behavioral Scientist Administrator, Epidemiology Research Branch
   — Enhancing Social Connectedness and Ameliorating Loneliness to Prevent and Treat SUD and Support Recovery - Carrie Mulford, Ph.D., Health Science Administrator, Services Research Branch
   — Registry of Medical Cannabis Use and Health Outcomes - Heather Kimmel, Ph.D., Health Science Administrator, Epidemiology Research Branch
   — Research Adoption Project - Tisha Wiley, Ph.D., Chief, Services Research Branch
   — Actionable data to inform research-driven decisions (HEAL Initiative Data2Action) - Tisha Wiley, Ph.D., Chief, Services Research Branch
   — Real-World Data to Address Urgent OUD/SUD Needs - Tisha Wiley, Ph.D., Chief, Services Research Branch
   
   Division of Neuroscience and Behavior (DNB)
   — Sequencing Resource for Molecular Genetics and Epigenetics of Addiction - Jonathan Pollock, Ph.D. Chief, Genetics, Epigenetics, and Developmental Neuroscience Branch
   — NIDA Center for Genetic Studies - Jonathan Pollock, Ph.D. Chief, Genetics, Epigenetics, and Developmental Neuroscience Branch— — Avenir Award Program for Genetics or Epigenetics of Substance Use Disorders - Jonathan Pollock, Ph.D. Chief, Genetics, Epigenetics, and Developmental Neuroscience Branch
   — Exploiting Genome or Epigenome Editing to Functionally Validate Genes or Variants Involved in Substance Use Disorders - John Satterlee, Ph.D. Health Scientist Administrator
   — Avenir Award for Chemistry and Pharmacology of Substance Use Disorders - Sam Ananthan, Ph.D. Chief, Chemistry and Pharmacology Branch
   — Workshops on Computational and Analytical Research Methods - Vani Pariyadath, Ph.D. Chief, Behavioral and Cognitive Neuroscience Branch
   
   Division of Therapeutics and Medical Consequences (DTMC)
   — NIDA Research Center of Excellence Grant Program - Kevin Walton, Ph.D. Chief, Clinical Research Grants Branch
   — Medications Development for Opioid Use Disorder (OUD) and Opioid Overdose (OOD) Expansion - Ivan Montoya, M.D., M.P.H. Acting Director, DTMC
   
   Division of Therapeutics and Medical Consequences (DTMC)
   — Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants Use Disorders (OUD/StUD) - Leonardo Angelone, Ph.D. Deputy Director, OTIPI

9. Public Comments (NIH Videocast @ 3:03:20)
   No public comments were submitted. 
10. Adjourn (NIH Videocast @ 3:05:53)
    The 139^th meeting of the National Advisory Council on Drug Abuse was adjourned at 4:23 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.