147th Meeting Minutes

Minutes – May 13, 2024

The National Advisory Council on Drug Abuse convened its 147th meeting at 10:30 a.m. on May 7, 2024. This meeting was conducted both in-person and virtually. The closed portion of the meeting held on May 7th 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 May 7, 2024, at 5:00 p.m.

Council Members Present
Arpana Agrawal, Ph.D.
Kate Beebe DeVarney, Ph.D.
Deborah Chassler, MSW
Charles Chavkin, Ph.D.
Anna Rose Childress, Ph.D.
Cristiane Duarte, Ph.D.
Amit Etkin, M.D., Ph.D.
Shelly Greenfield, M.D., M.P.H.
Helena Hansen, M.D., Ph.D.
Regina LaBelle, J.D.
Angela Laird, Ph.D.
Melanie Ott, M.D., Ph.D.
Travis Rieder, Ph.D.
Rajita Sinha, Ph.D.
Mark VonZastrow, M.D., Ph.D.

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

Non-Federal Employees Present
Mary Elizabeth Chandler
Miles Chandler
Courtney Chandler
William L. Dewey, Ph.D
Patricia Dewey
William P. Dewey
Michael Dewey
Linda Mitchell
Matthew Mitchell
Michael Mitchell
Susan Ulmer
Jeffrey Ulmer

During the Open Session of Council, 208 participants joined live via videocast.

Closed Portion of the Meeting - May 13, 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. Carlos Blanco, Elena Koustova, Iván Montoya, Rita Valentino, Directors of NIDA’s Division of Epidemiology, Services, and Prevention Research, Office of Translational Initiatives and Program Innovations, Division of Therapeutics and Medical Consequences, Division of Neuroscience and Behavior, and Dr. Aria Crump, Deputy Director of NIDA’s Office of Research Training, Diversity, and Disparities, 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. Two foreign applications and five administrative supplements were presented to Council; Council concurred with program assessments. Seven 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 1,582 applications requesting $713.1 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.
2. Council Member Announcements
   Dr. Nora Volkow thanked Anna Rose Childress, Dennis Deer, Shelley Greenfield, Andrey Ostrovsky, Travis Reider, Rajita Sinha, and Melissa Walls for their service on NACDA and announced this as their last NACDA meeting.
   
   Dr. Nora Volkow welcomed new Council members Cristiane Duarte, Regina LaBelle, Angela Laird, and Deborah Chassler.
3. Consideration of the Minutes of Council     
   The Minutes of the February 2024 NIDA Advisory Council were unanimously approved as written.
   
   She then called attention to future Council meeting dates: September 11, 2024, February 4, 2025, and May 13-14, 2025.
4. NIDA Director’s Report (NIH Videocast @ 0:9:00) – Nora Volkow, M.D., Director, NIDA
   Dr. Volkow began by updating Council on NIH pay increases for pre- and postdoctoral scholars and highlighting a new Common Fund program to establish a primary-care focused clinical research network. She also mentioned the upcoming BRAIN Initiative Conference and 10-year celebration. Dr. Volkow then discussed the budget constraints of a flat budget for FY24 and introduced Dr. Iván Montoya as director of DTMC. Next, she provided updates on the ABCD and HBCD study, emphasizing the new data sharing platform which will harmonize data across studies and provide a rich dataset for all researchers. She presented updated data on drug overdose deaths and specifically noted a decrease in overall drug deaths, but a rise in deaths with synthetic opioids, cocaine, and other psycho-stimulants. Dr. Volkow then discussed drivers of overdose deaths and access to treatment. She provided updates on NIDA programs including treatment and intervention research with the Clinical Trials Network (CTN) in local healthcare systems, JCOIN in the justice system, and HEALing Communities study in both rural and urban settings. She detailed results and challenges of the HEALing Communities study which did not result in a significant decrease in opioid-overdose deaths but did in combined opioid and psychostimulant overdose deaths. She continued discussing overdoses with multiple substances and highlighted the use of xylazine, emphasizing research needs as determined by a recent CTN meeting examining xylazine-adulterated opioids. In addition, she highlighted OTIPI funded research leading to FDA approved fentanyl testing kits. Dr. Volkow discussed overdose deaths by race and ethnicity, noting higher rates of overdose in American Indian/Alaska Native populations and the recently launched Native Collective Research Effort to Enhance Wellness (N CREW) program which will work with Tribes and Native American Serving Organizations to research overdose, substance use, and pain. She concluded by identifying therapeutics for polysubstance use and challenges to the current overdose epidemic.
   
   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 1:09:36).
5. NIDA Lifetime Achievement Award presented to Dr. William Dewey (NIH Videocast @ 1:33:05)
   Dr. Nora Volkow presented the NIDA Lifetime Achievement Award to Dr. William Dewey. She described his commitment to substance use research over 50-plus years, his dedication to training scientists, and his development of the Friends of NIDA.
6. The Division of Neuroscience and Behavior: Advancing the Neuroscience of Addiction (NIH Videocast @ 1:44:50) – Rita Valentino, Ph.D., Director, Division of Neuroscience and Behavior
   Dr. Rita Valentino began by highlighting major research advances over the past 50 years in the neuroscience of addiction. She addressed challenges in SUD research and detailed the work of the Division of Neuroscience and Behavior across the different branches.
   
   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:08:50).
7. Concept Clearances  (NIH Videocast @ 2:19:00)
   
   Office of Translational Initiatives and Program Innovations (OTIPI)
   – Fostering Lay Community and Community with Lived Experience Awareness on Biomedical Product Development for Substance Use Disorders – Jess Lukacs, M.D, MBA.
   – Promoting Medical Device Development for the Youth Affected by Drug Addiction and Substance Misuse – Leonardo Angelone, Ph.D.
   – Rapid and Drug-Agnostic Identification of Emerging Threats – Yordan Kostov, Ph.D.
   – Building an Innovation Platform for the Repurposing of Medicinal Products for Substance Use Disorders – Saravanan Karuppagounder, Ph.D.
   
   Division of Therapeutics and Medical Consequences (DTMC)
   – Clinical Research on HIV-Associated Pain in the Context of Substance Use Disorders – Raul Mandler, M.D.
   – Developing Medications and Devices for Comorbid Substance Use Disorders – Drew Townsend, Ph.D.
   – Discovery and Development of Natural Products to Treat Substance Use Disorders (SUDs) – Jai Bei Wang, M.D., Ph.D.
   – Annual Conference in Therapeutics Development for Substance Use Disorders – Ivan Montoya, M.D., M.P.H.
   
   Division of Neuroscience and Behavior (DNB)
   – Fundamental Research into Mechanisms that Contribute to HIV-Associated Pain in the context of Substance Use Disorders – Tristan McClure-Begley, Ph.D.
   – Discovery and Characterization of Anti-Addictive Neural Circuits and Mechanisms – Tristan McClure-Begley, Ph.D.
   – Neuromodulation Controllers in Substance Use Disorder – Tristan McClure-Begley, Ph.D.
   – Multisensory Integration, Interoception and Substance Use Disorder – Tristan McClure-Begley, Ph.D.
   – Maternal Mortality from Drug Overdose: Causes, Mechanisms and Treatment – Sunila Nair, Ph.D.
   – Effects of HIV on drug-seeking and Impulsive Behavior – Jonathan Pollock, Ph.D.
   – In Vivo Research on the Effects of Methamphetamine Use on HIV Infection, Expression, and Persistence - Da-Yu Wu, Ph.D.
   – Exploring the Roles of Endocannabinoids and the Effects of Exogenous Cannabinoids on Brain Development – Da-Yu Wu, Ph.D.
   – Sustained Addiction Recovery: Mechanisms, Attributes, Process, and Persistence (STAR-MAPP) – John Satterlee, Ph.D.
   – Data Integration to Reveal Biological Pathways Underlying SUDs – Susan Wright, Ph.D.
8. Public Comments (NIH Videocast @ 2:57:40)    
   No public comments were submitted. 
9. Adjourn (NIH Videocast @ 2:59:45)       
   The 147th 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.