144th Meeting Minutes

Minutes – May 9, 2023

The National Advisory Council on Drug Abuse convened its 144th meeting at 10:30 a.m. on May 9, 2023. This meeting was conducted both virtually and in-person. The closed portion of the meeting held on May 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 12:45 p.m. and was also videocast. The Council adjourned on May 9, 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.
Helena Hansen, M.D., Ph.D. (ad hoc)
Paul Kenny, Ph.D.
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, 201 participants joined live via videocast. 

Closed Portion of the Meeting - May 9, 2023

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 4 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. Rita Valentino, Aria Crump, Carlos Blanco, Elena Koustova, Iván Montoya, Directors of NIDA’s Division of Neuroscience and Behavior, 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, 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. Twenty-five administrative supplements and two foreign application were presented to Council; Council concurred with program assessments. Four 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 1,658 applications requesting $870.7 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. 

Open Portion of the Meeting - May 9, 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: September 12, 2023 and February 6, 2024. 
2. Acknowledge Departing Council Members and Introduce New Council Members      
   Dr. Volkow thanked departing Council Members Jessica Hulsey, Daniel Goonan, Dr. Paul Kenny, and Dr. Sharon Walsh for their service. She then introduced Dr. Helena Hansen (ad hoc member) to NACDA. 
3. Consideration of the Minutes of Council     
   The Minutes of the February 2023 NIDA Advisory Council were unanimously approved as written. 
4. NIDA Director’s Report (NIH Videocast @ 0:5:30) – Nora Volkow, M.D., Director, NIDA     
   Dr. Nora Volkow began by reviewing NIDA’s final budget for FY2022-FY2023 and the FY2024 President’s Budget. She then gave an overview of NIDA staffing, welcoming the newest director of the Office of Diversity and Health Disparities (ODHD), Aria Crump and the Clinical Director of the Intramural Research Program (IRP), Dr. Lorenzo Leggio. She highlighted the ongoing searches for Executive Officer and Director of DTMC. Dr. Volkow presented updates on the BRAIN Initiative and noted the upcoming 9th Annual BRAIN Initiative Meeting. Next, she discussed the Adolescent Brain Cognitive Development StudySM (ABCD) study and highlighted research showing that antipoverty programs are associated with reduced disparities in brain development and mental health. She then provided updates to the HEALthy Brain and Child Development Study (HBCD) before presenting data on US State Cannabis Laws and adverse adolescent psychosocial events to cannabis use. Dr. Volkow discussed overdose deaths before presenting data on the rise in xylazine use and its effects on brain oxygenation in combination with fentanyl use. She then discussed fentanyl use and fentanyl overdoses in youth and the need for more research on implementing screening interventions, prevention research, and treatment in teenagers. Dr. Volkow detailed the substance use disorder (SUD)/opioid use disorder (OUD) prevention cascade and specifically discussed the effects of social determinants of health and the need for infrastructure to deploy and sustain prevention efforts. She then covered research gaps and clinical research priorities for fentanyl OUD and OUD and the impact of social determinants of health on treatment responses in clinical trials. Lastly, Dr. Volkow presented research with the aim to identify brain networks underlying SUD to provide therapeutic targets for neuromodulation using invasive and non-invasive methods. She concluded by highlighting proposed rule changes to make permanent telemedicine flexibilities that were adopted during the COVID-19 Public Health Emergency and first approved over-the-counter naloxone nasal spray from the FDA.      
   
   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 54:02). 
5. Medications Development Council Workgroup Report (NIH Videocast @ 1:48:23) – Iván Montoya, M.D., M.P.H., Acting Director, DTMC      
   Dr. Iván Montoya presented updates to Council from the Medications Development Council Workgroup which met on November 10th, 2022. DTMC was seeking the workgroup’s overall impressions on the research portfolio including identifying any gaps in the portfolio, if they felt the divisions priority of projects was sufficient, and suggestions for new compounds or mechanisms that should be evaluated. Dr. Montoya detailed the status of a number of targets and mechanisms that are currently being considered including for Nicotine/Tobacco use Disorder, Cannabis Use Disorder, Opioid Use Disorder, and Stimulant Use Disorder. He identified a number of active pharmaceutical collaborations and future projects. Overall, the workgroup provided positive feedback on the Division’s current work.      
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:19:09). 

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

   Division of Neuroscience and Behavior (DNB)       
   – Joint NIDA/NIMH Concept: Using Neuromodulation to Characterize the Continuum of Pathophysiology Between Substance Use and Mental Health Disorders – John Fedota, Ph.D.      
   – Mechanistic Studies on Social Behavior in Substance Use Disorder – Vani Pariyadath, Ph.D.      
   – Studying the Neuroplastic Effects of Addictive and Therapeutic Substances Using Next Generation Quantitative Readouts of Synaptic Connectivity – Olivier Berton, Ph.D. 

   Division of Epidemiology, Services, and Prevention Research (DESPR)       
   – Adolescent Overdose Prevention and SUD Treatment Initiative – Sean Lynch, Ph.D., LCSW      
   – Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies – Sarah Steverman, Ph.D., MSW      
   Council voted to approve this concept.        
   – Facilitating Translation from Epidemiology to Prevention Intervention through “Sandpit”- and “Hackathon”-Like Meetings – Alexa Romberg, Ph.D.      
   
   Office of Translational Initiatives and Program Innovations (OTIPI)      
   – Taking the First Step In Translating New SUD Research Ideas: Centers to Support Early Technical Development for Pharmacotherapeutics and Digital Therapeutics – Stacie Gutowski, Ph.D.     
   – Artificial Intelligence-Enabled Translation of Interconnected Targets into New Pharmacotherapeutics for Substance Use Disorders (SUD) – Tam Nguyen, Ph.D.      
   – Tools for Decentralized Clinical Trials – Yordan Kostov, Ph.D.     
   – Solutions to Enable Equitable Diagnosis and Treatment of Adverse Health Consequences for People who Misuse Drugs – Leonardo Angelone, Ph.D. 

   Division of Therapeutics and Medical Consequences (DTMC)       
   – Combined Neuromodulation and Behavioral Treatment Algorithm Development for Stimulant Use Disorder (StUD) Enriched for Vulnerable Phenotype – Tanya Ramey, M.D., Ph.D.     
   – Psychedelic Treatment Research for Alcohol and/or Substance Use Disorder – Tanya Ramey, M.D., Ph.D.       
   
   Center for the Clinical Trials Network (CCTN)      
   – National Drug Abuse Treatment Clinical Trials Network – Node Infrastructure – Betty Tai, Ph.D.      
   – National Drug Abuse Treatment Clinical Trials Network - Clinical Coordinating Center – Ron Dobbins, MBA      
   Council voted to approve this concept. 

7. NIDA’s Office of Translational Initiatives and Program Innovations (OTIPI) (NIH Videocast @ 3:11:30) Elena Koustova, Ph.D., M.B.A. Director, OTIPI   
8. Public Comments (NIH Videocast @ 3:51:11)    
   No public comments were submitted. 
9. Adjourn (NIH Videocast @ 3:51:50)       
   The 144th 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.