146th Meeting Minutes

Minutes – February 6, 2024

The National Advisory Council on Drug Abuse convened its 146th meeting at 10:30 a.m. on February 6, 2024. This meeting was conducted virtually. The closed portion of the meeting held on February 6th 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 videocast. The Council adjourned on February 6, 2024, at 5:00 p.m.

Council Members Present
Arpana Agrawal, Ph.D. 
Kate Beebe De Varney, Ph.D. 
Charles Chavkin, Ph.D. 
Anna Rose Childress, Ph.D.
Amit Etkin, M.D., Ph.D.
Shelly Greenfield, M.D., M.P.H.
Helena Hansen, M.D., Ph.D.
Andrey Ostrovsky, M.D.
Melanie Ott, M.D., Ph.D.
Travis Rieder, Ph.D. 
Rajita Sinha, Ph.D.
Melissa Walls, Ph.D. 

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present
Paul Kenny, Ph.D. – Icahn School of Medicine at Mount Sinai
Fran Kerrigan
John Mantsch, Ph.D. – Medical College of Wisconsin
Sharon Walsh, Ph.D. – University of Kentucky School of Medicine

During the Open Session of Council, 250 participants joined live via videocast.

Closed Portion of the Meeting - February 6, 2024

1. Call to Order     
   This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., and section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014).
   
   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, Ivan Montoya, Rita Valentino, and Carlos Blanco, 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, presented their Division's/Office's assigned and peerreviewed applications for consideration by the Council. For each application, Council provided unanimous en bloc concurrence with the initial scientific review. Three administrative supplements were presented to Council; Council concurred with program assessments. Six Special Council Review applications were presented as well. 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 1,343 applications requesting $692.6 million in first-year direct costs.
   
   Council and staff were recused from the Council meeting during the 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 - February 6, 2024

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 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 7, 2024 and September 11, 2024.
2. Consideration of the Minutes of Council     
   The Minutes of the September 2023 NIDA Advisory Council were unanimously approved as written.
3. NIDA Director’s Report (NIH Videocast @ 0:3:05) – Nora Volkow, M.D., Director, NIDA
   Dr. Nora Volkow began by welcoming the new director of the NIH, Dr. Monica Bertagnolli. She also updated council members on the NIH Fellows United that voted on December 7, 2023, to be represented by the International Union of United Automobile, Aerospace, and Agricultural Implement Workers of America (UAW). NIH will partner with UAW to negotiate a collective bargaining agreement, work on the bargaining agreement will continue through 2024. Dr. Volkow also highlighted exciting advances from BRAIN. Last year, a whole volume of Nature was dedicated to the complete cell census and atlas of the mammalian brain. She also invited council members to attend the Annual BRAIN conference on June 17-18, 2024. Dr. Volkow then reviewed NIDA's budget for FY 22-23 and the FY2024 president's budget. She gave an overview of NIDA staffing, welcoming Dr. Ivan Montoya as the director of the Division of Therapeutics and Medical Consequences, and Dr. Michele Rankin, as the director of the NIDA HEAL Office. Dr. Volkow then presented data from the 2023 Monitoring the Future Survey which queries the prevalence of past year and lifetime drug use among 8th, 10th, and 12th graders
   which showed that alcohol, vaping, and marijuana have the highest prevalence rates among this age group. Of concern is the steady daily use of marijuana in teenagers. She also presented data from the National Survey of Drug Use and Health. She then gave an update on the Adolescent Brain Cognitive Development (ABCD) study and the HEALthy Brain and Child Development Study. Dr. Volkow discussed the overdose crisis and overdose-related deaths, the importance of access to treatment and effective medications, and the HHS Overdose Prevention Strategy. She described the Harm Reduction Research Network that was launched last year. Dr. Volkow then presented data on unintentional fentanyl overdoses in 15-19-year-olds, which remain elevated, and highlights how crucial it is to do prevention. The National Academies has been engaged to develop a blueprint for a National Prevention Infrastructure for Behavioral Health Disorders, for which the first meeting was held recently. She highlighted the need for effective treatments for adolescents with substance use disorders. Dr. Volkow ended with the announcement of the Population Assessment of Tobacco and Health (PATH) Study continuation, and the award to NIDA for the ICO that sponsored the most NIH Challenges in FYl 1-23.
   
   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 1:02:14).
4. Overview & Updates from the Justice Community Opioid Innovation Network (JCOIN) (NIH Videocast @ 1:44:09) – Tisha Wiley, Ph.D., Branch Chief, Services Research Branch, Associate Director for Justice Systems.
   Dr. Tisha Wiley presented updates on the Justice Community Opioid Innovation Network (JCOIN). She described how the criminal legal system is one of the points of highest impact for targeting interventions for substance use disorders (SUD) but needs to include communities. This led to the JCOIN vision that every individual involved in the justice system with an SUD should have access to effective treatment while detained and while in the community. JCOIN has funded 13 research hubs which are funding 13 multisite clinical trials, which cover 140 counties in 38 states and Puerto Rico. They have >22,800 participants enrolled in their clinical trials. There are 2 support centers and more than 55 research protocols that have been implemented. Dr. Wiley described a couple of recent notable papers that were disseminated into the public domain using webinars, podcasts, etc. She also described data tools and resources that are available and other areas where JCOIN has made an impact. Dr. Wiley also described efforts for building capacity. She described the next step for JCOIN (JCOIN 2.0). Awards for infrastructure support are expected to begin summer of 2024 and research hubs will follow later. Dr. Wiley ended by announcing that the JCOIN 1.0 scientific meeting will be held June 11-13, 2024.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:19:56).
5. MERIT Award Update and Recommendations (NIH Videocast @ 2:22:12) – Susan R.B. Weiss, Ph.D., Director, Division of Extramural Research
   Dr. Susan Weiss presented updates on the future of the Method To Extent Research in Time (MERIT) awards at NIDA. She provided a recap of the current NIDA MERIT (R37) guidelines and an analysis of what other ICs are doing with MERIT awards. Historical information was brought to the May 2023 council and following that a working group was convened to provide recommendations. Follow-up discussions at NIDA resulted in strong support for an award for ESis. Dr. Weiss ended by providing an overview of what the new MERIT award would look like, the process for selecting the awards and the extension process, and the edibility criteria.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:35:22).
6. Concept Clearances  (NIH Videocast @ 2:46:33)
   
   Division of Neuroscience and Behavior (DNB)
   – Advancing Research on Molecular Targets and Mechanisms that Influence the Interplay between Sex Hormones, Addictive Substances, and HIV Infection – Sam Ananthan, Ph.D.
   – Mitochondrial-associated Mechanisms ofNeuropathological and Immunodeficient Aging in the Context of HIV and SUD – Kathleen Borgmann, Ph.D.
   – Waste Not, Want Not: Exploring interactions between brain waste clearance and renewal systems with HIV and addiction – Kathleen Borgmann, Ph.D.
   – Mechanisms of cell-cell interactions and communication in CNS HIV replication – Shang-Yi Tsai. Ph.D.
   
   Office of Research Training, Diversity, and Disparities (ORTDD)
   – Data-Science Track Award for Research Transition (D-Start) – Yohansa Fernandez, Ph.D.
   
   Division of Epidemiology, Services, and Prevention Research (DESPR)
   – Research to Address Multi-Level Barriers and Facilitators to Improve the HIV PreExposure Prophylaxis (PrEP) Care Continuum for People Who Use Substances – Angela Lee-Winn, Ph.D.
7. Public Comments (NIH Videocast @ 2:56:23)    
   No public comments were submitted. 
8. Adjourn (NIH Videocast @ 2:56:33)       
   The 146th meeting of the National Advisory Council on Drug Abuse was adjourned at 5:00 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.