143rd Meeting Minutes

Minutes – February 8, 2023

The National Advisory Council on Drug Abuse convened its 143rd meeting at 11:00 a.m. on February 8, 2023. This meeting was conducted virtually. The closed portion of the meeting held on February 8th was for reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. During the closed session, Council also met with the Chairs of the Board of Scientific Counselors to receive updates on the Intramural Program. The open portion, which was open to the public, began at 1:15 p.m. and was also videocast. The Council adjourned on February 8, 2023 at 5:00 p.m.

Council Members Present
Arpana Agrawal, Ph.D.
Kate Beebe DeVarney, Ph.D.
Charles Chavkin, Ph.D.
Anna Rose Childress, Ph.D.
Dennis Deer, Ph.D.
Amit Etkin, M.D., Ph.D.
Daniel A. Goonan
Shelly Greenfield, M.D. M.P.H.
Paul Kenny, Ph.D.
Jessica Hulsey Nickel
Andrey Ostrovsky, M.D.
Melanie Ott, M.D., Ph.D.
Travis Rieder, Ph.D.
Rajita Sinha, Ph.D.
Mark VonZastrow, M.D., Ph.D.
Melissa Walls, Ph.D.
Sharon Walsh, Ph.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

During the Open Session of Council, 232 participants joined live via videocast.

Closed Portion of the Meeting - February 8, 2023

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. Aria Crump, Carlos Blanco, Elena Koustova, Iván Montoya, and Rita Valentino, Directors of NIDA’s Office of Diversity and Health 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. Eight administrative supplements and 1 foreign application were presented to Council; 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. In total, Council concurred with the initial review of 1,522 applications requesting $699.2 million in first-year 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.

3. Report to Council from the Board of Scientific Counselors
   
   Dr. John Mantsch, the Chair of the Board of Scientific Counselors (BSC), provided an overview to Council on the most recent BSC review of the NIDA Intramural Research Program (IRP).

Open Portion of the Meeting - February 8, 2023

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 9-10, 2023 and September 12, 2023.

2. Consideration of the Minutes of Council

   The Minutes of the September 2022 NIDA Advisory Council were unanimously approved as written.

3. Introduce New Council Members 

   Dr. Volkow introduced new NACDA members: Arpana Agrawal, Ph.D., Kate Beebe DeVarney, Ph.D., Melanie Ott, M.D., Ph.D., Mark Von Zastrow, M.D., Ph.D.

4. NIDA Director’s Report (NIH Videocast @ 0:6:50) – Nora Volkow, M.D., Director, NIDA

   Dr. Nora Volkow began by reviewing NIDA’s final budget for FY2022-FY2023, including base funding and HEAL funding across all divisions. She then gave an overview of NIDA staffing, welcoming the newest director of the Office of Diversity and Health Disparities (ODHD), Aria Crump, and highlighting the searches for Executive Officer, Clinical Director, and Director of DTMC. Dr. Volkow mentioned proposed changes to Peer Review of Research Grants and noted the active Request for Information. She then presented updates on the BRAIN Initiative and noted the productivity and growth in the program since 2014. The next Annual BRAIN Initiative Meeting will take place in June. Dr. Volkow updated Council on the 2022 Monitoring the Future Study, which showed that the prevalence of drug use remained at or below-pre-pandemic levels. Regarding marijuana, there is an increase in states with legalized cannabis use, and with the rise in legalization, there has been an increase in cannabis use among adults. NIDA has prioritized researching the potential negative effects of marijuana consumption among young people and pregnant women, which led to the creation of the Adolescent Brain Cognitive Development (ABCD) Study and the HEALthy Brain and Child Development (HBCD) Study. These prospective studies enable researchers to monitor whether drug exposure in utero and during adolescence affects brain development. She highlighted research showing that cannabis use may affect synaptic density in the hippocampus and discussed research priorities related to cannabis, including its potential in management of SUD, HIV or pain. She then provided updates on the ABCD study and highlighted recent research. Regarding HBCD, she noted that the study began enrolling participants for the pilot study and that training for all research sites is underway to ensure uniformity across the study. Next, Dr. Volkow presented rates in drug overdose deaths and highlighted NIDA’s interest in using HEAL money for services and implementation research to go towards preventing overdoses. She discussed the rise in synthetics linked to opioid overdose and the dangers of fentanyl and its analogues and the need for alternative treatments for overdose reversals. Dr. Volkow highlighted factors that contribute to the rise in synthetic opioids and noted the increase in deaths from fentanyl in teenagers, particularly in males. In addition, she discussed the years of life lost due to overdose in adolescents and the rise in use of Xylazine. Lastly, Dr. Volkow addressed recent legislation which removed the patient cap for buprenorphine prescribing and called for additional training on substance use for practitioners renewing or applying for DEA registration. This will hopefully expand access, although practitioners prescribing buprenorphine for OUD will still be held to state laws and requirements and insurance rules, which may lead to heterogeneity in access across states. Dr. Volkow concluded by highlighting research to address overdose deaths.

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

5. What’s HOT at the NIDA-IRP (NIH Videocast @ 1:24:20) – Amy Newman, Ph.D., Scientific Director, NIDA IRP

   Dr. Amy Newman presented updates on the NIDA Intramural Program (IRP). The IRP aims to support highly innovative, high risk and long-term research into mechanisms/circuitry underlying SUD with the goal of translating findings into improvements in prevention and treatment. The IRP is focused on providing mentoring and training opportunities to advance scientific careers and promoting a diverse, inclusive, and collegial culture. Dr. Newman briefly discussed the challenges of operating during COVID-19 and the ways the IRP adapted. She then presented her future vision for the IRP. Specifically, she aims to expand the clinical portfolio through additional hiring and partnerships with NCATS and the pharmaceutical industry. In addition, the IRP seeks to invest in strong basic science and technology by expanding technology cores and implementing the Technology Development Initiative. She then presented new technology at the IRP and recent research advances. Dr. Newman highlighted the need for trans-NIH initiatives and noted collaborations with NIMH, NIDDK, NIAAA, NCCIH, and NINDS. Next, she recognized the accomplishments of IRP investigators and the steps taken to strengthen the IRP culture and personnel through diversity and inclusion. Lastly, Dr. Newman highlighted the outreach efforts of the IRP across the community.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 1:48:25).

6. MERIT Award Workgroup Updates (NIH Videocast @ 2:04:26) – Susan Weiss, Ph.D., Director, Division of Extramural Research

   Dr. Susan Weiss provided updates to NACDA on the MERIT Award Workgroup. She reminded Council of the current NIDA MERIT Award guidelines and gave a brief overview of prior discussions at Council that preceded the formation of the workgroup. The Future of NIDA MERIT Awards workgroup was charged with reviewing the current criteria for the award and considering if changes are needed, if the criteria should remain the same, or if the MERIT award should be discontinued. Membership included Drs. Sara Becker, Debra Furr-Holden, Brandon Henderson, Paul Kenny, Melissa Walls, and Sharon Walsh. This included NACDA members, non-NACDA members and two current MERIT awardees. Dr. Weiss highlighted discussion topics from the two workgroup meetings, including considering investigators at different career stages, expanding the awards to multi-PI applications, changing the length of the award, and prioritizing research on equity. The workgroup also emphasized the need to evaluate the success of any changes made to the award.

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:18:20).

7. Concept Clearances (NIH Videocast @ 2:57:15)

   Office of Research Training, Diversity, and Disparities (ORTDD)
   – NIDA Research Education Program for Clinical Researchers and Clinicians – Aria Crump, Ph.D.

   Division of Epidemiology, Services, and Prevention Research (DESPR)
   – National Addiction & HIV Data Archive Program (NAHDAP) – Janet Kuramoto-Crawford, Ph.D.
   Council voted to approve this concept. 
   – American Indian and Alaska Native Collective Research Effort to Enhance Wellness (AI/AN CREW): Addressing Opioid/Drug Misuse, Mental Health and Pain – Kathy Etz, Ph.D.
   Council voted to approve this concept. 
   – Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services – Minnjuan Flournoy Floyd, Ph.D. 
   – Engaging Survivors of Sexual Violence and Trafficking in HIV and Substance Use Disorder Services – Minnjuan Flournoy Floyd, Ph.D. 
   – Addressing HIV in Highest Risk Sexual and Gender Minorities – Richard Jenkins, Ph.D. 
   – Cohort Studies of HIV/AIDS and Substance Use – Sheba Dunston, Ed.D., M.P.H., CHES
   – Research to Address SUD in the Criminal-Legal System – Tisha Wiley, Ph.D.
   – Research to Increase Implementation of Substance Use Preventive Services – Amy Goldstein, Ph.D.
   – Resource Networks to Advance the Impact of Addiction Services Research through Researcher/Decision Maker Collaborations – Sarah Duffy, Ph.D.

   Division of Therapeutics and Medical Consequences (DTMC)
   – Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools for Opioid and Stimulant Use Disorders to Accelerate Therapeutic Development – Tanya Ramey, M.D., Ph.D.

   Division of Neuroscience and Behavior (DNB)
   – Ex vivo Models for Studies at the Intersection of HIV and Poly-Substance Use – Da-Yu Wu, Ph.D.
   – Mechanistic Studies on the Effects of Psychosocial Stress in Complex Morbidity Involving SUD/s, Psychiatric Disorders, and HIV – Sunila Nair, Ph.D.
   – Effects of HIV and Substance Use Comorbidity on the Placenta – Sunila Nair, Ph.D.
   – Interplay of Autophagy Regulated Cell Death and HIV Pathogenesis in Substance Use Disorders – Anne Tsai, Ph.D.
   – Targeting Inflammasomes in Substance Use and HIV – Anne Tsai, Ph.D.
   – Research on the Neuro-Immune Axis in the Context of HIV and Substance Use – Kiran Vemuri, Ph.D.
   – Chemical Probes and Drugs for Modulating HIV Transcription in People with Substance Use Disorders – Sam Ananthan, Ph.D.
   – Microglial Pathophysiology in Comorbid HIV and SUD – Tristan McClure-Begley, Ph.D.
   – SCORCH (Single Cell Opioid Responses in the Context of HIV) Program: Data Coordination, Analysis, and Scientific Outreach – John Satterlee, Ph.D.
   – SCORCH (Single Cell Opioid Responses in the Context of HIV) Program: Data Mining and Functional Validation – John Satterlee, Ph.D.

   Office of Research Training, Diversity, and Disparities (ORTDD)
   – ABCD Study® Data Sharing Platform – Elizabeth Hoffman, Ph.D.
   Council voted to approve this concept.

8. Public Comments (NIH Videocast @ 3:27:05)
   
   No public comments were submitted.
9. Adjourn (NIH Videocast @ 3:27:30)
   
   The 143rd 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.