145th Meeting Minutes

Minutes – September 12, 2023

The National Advisory Council on Drug Abuse convened its 145th meeting at 10:30 a.m. on September 12, 2023. This meeting was conducted both virtually and in-person. The closed portion of the meeting held on September 12th 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 1:00 p.m. and was also videocast. The Council adjourned on September 12, 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.
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.
Mark VonZastrow, M.D., Ph.D.
Melissa Walls, Ph.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present
Paul Gaist, Ph.D. – Johns Hopkins University

During the Open Session of Council, 212 participants joined live via videocast.

Closed Portion of the Meeting - September 12, 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 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. Iván Montoya, Rita Valentino, Aria Crump, Carlos Blanco, Elena Koustova, Directors of NIDA’s Division of Therapeutics and Medical Consequences, Division of Neuroscience and Behavior, Office of Diversity and Health Disparities, 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. Seven administrative supplements were presented to Council; Council concurred with program assessments. One Special Council Review application was 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 1,386 applications requesting $654.5 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 - September 12, 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: February 6, 2024, May 7-8, 2024, and September 11, 2024. 
2. Consideration of the Minutes of Council     
   The Minutes of the May 2023 NIDA Advisory Council and CRAN meeting were unanimously approved as written.
3. Review of Operating Procedures
   A change was made to the Operating Procedures indicating Council approval is not needed for diversity supplements. Council unanimously approved the change.
4. NIDA Director’s Report (NIH Videocast @ 0:3:19) – 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 Executive Officer and Deputy Director for Management, Nathaniel Davis. She highlighted the ongoing search for Director of DTMC. Dr. Volkow announced the administrative transition of the Helping to End Addiction Long-term (HEAL) initiative from the NIH Office of the Director to NIDA and NINDS. Next, she provided updates on the Native Collective Research Effort to Enhance Wellness (N-CREW) initiative which aims to partner with Native organizations to lead research to address the overdose crisis. Following this, she discussed the Adolescent Brain Cognitive Development StudySM (ABCD) and the HEALthy Brain and Child Development Study (HBCD) and highlighted an upcoming ABCD meeting in March 2024. Dr. Volkow then discussed drug overdose deaths by substance, highlighting the change from 2022 to 2023. She presented new drug treatments, including FDA approvals for intranasal Nalmefene, a new buprenorphine treatment for opioid use disorder, and the first over-the-counter Naloxone nasal spray. She then noted FDA authorization for Cessation Therapeutic’s first-in-human clinical trial of an antibody for prevention of fentanyl overdose. Dr. Volkow noted the recent publication of a Notice of Special Interest (NOSI) on understanding xylazine use and consequences that is now open for applications. She then presented data on unintentional drug overdose deaths and opioid misuse among youth in the US. She highlighted a National Academies committee that will develop a blueprint for specific, actionable steps for building and sustaining an infrastructure for delivering prevention interventions targeting risk factors for behavioral health disorders. Dr. Volkow congratulated the Intramural Program on their tremendous success in influential publications. Lastly, she noted that the Biden Administration is reviewing how marijuana is scheduled under federal law. Dr. Volkow ended by mentioning the U.S. Preventive Services Task Force recommendation that clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy for persons at increased risk of HIV acquisition to decrease the risk of acquiring HIV.
   
   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 57:32).
5. Substance Use in the Context of HIV and National HIV Efforts (NIH Videocast @ 1:30:06) – Harold Phillips, MRP, Director, White House Office of National AIDS Policy  
   Mr. Phillips first provided an overview of HIV and substance use, particularly the relationship between injection drug use and HIV. Next, he detailed the National HIV/AIDS Strategy (NHAS) for 2022-2025, highlighting priority populations they wish to target and the goals of the strategy including, but not limited to, the impacts of racism, harm reduction strategies, and social determinants of health. The implementation of the plan will involve 10 federal departments and include programs, policies, research, and other activities. Mr. Phillips also discussed the NHAS Quality of Life Indicators and the five new indicators that were added. He then focused on approaches to address HIV associated with substance use and the different options for prevention and treatment. Mr. Phillips provided updates from the White House Office of National Drug Control Policy as it relates to harm reduction and HIV and addressed some of the current challenges and opportunities in the National HIV effort. He concluded with a call to action for stakeholders from all sectors of society to engage in a more coordinated, re-energized national response to HIV.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:00:30).
6. NIDA’s Office of HIV Research (NIH Videocast @ 2:16:00) – Redonna K. Chandler, Ph.D., Director, HIV Research Program
   Dr. Chandler first gave an overview of NIDA’s HIV Research budget and the research it supports from basic/preclinical science to clinical research, and implementation science. She then discussed HIV in the context of the Opioid Epidemic and substance use disorders including reducing overdose risks and treating chronic pain. Dr. Chandler presented research on fentanyl and HIV replication, social genomics, and social determinants of health. She highlighted NIDA funded research on medications for opioid use disorder and its impact on HIV transmission and the new U.S. Preventive Services Task Force recommendations to prescribe pre-exposure prophylaxis (PrEP) to persons at increased risk for HIV acquisition, including people who inject drugs (PWID). Lastly, Dr. Chandler discussed discrimination and implicit bias in treatment of PWID and PWID living with HIV. She concluded by discussing the future impact of climate change on substance use disorders and HIV.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:39:53).
7. Center for the Clinical Trials Network Meeting Highlights Xylazine and Opioids: Clinical Experiences and Research Questions (NIH Videocast @ 2:49:45) – Kristen Huntley, Ph.D., Associate Director, Center for the Clinical Trials Network
   In response to the growing prevalence of xylazine in patients who use opioids, the Center for the Clinical Trials Network (CCTN) held a meeting in June on management of patients taking xylazine-adulterated opioids in emergency, hospital, and addiction care settings. Dr. Huntley provided highlights from the meeting including discussions on clinical manifestations of withdrawal and overdose, wounds, and testing. Dr. Huntley noted a recently published Notice of Special Interest (NOSI) by NIDA on Xylazine. Lastly, she highlighted an upcoming event to further the discussion on Xylazine.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 3:09:30).

8. Concept Clearances  (NIH Videocast @ 3:19:25)

   Division of Epidemiology, Services, and Prevention Research (DESPR)       
   – National Drug Early Warning System (NDEWS) – MeLisa Creamer, PhD
   – Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders – Keisher Highsmith, DrPH
   – Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials – Amy Goldstein, PhD  
   
   Office of Translational Initiatives and Program Innovations (OTIPI)      
   – Seeking Products to Address Social Needs impacting Substance Use Disorders (SUD) – Morris Flood, DHSc

9. Public Comments (NIH Videocast @ 3:24:50)    
   No public comments were submitted. 
10. Adjourn (NIH Videocast @ 3:25:30)       
    The 145th 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.