[#DIV28SUPER] FDA/NIDA virtual meeting on stimulant use disorder treatment: October 18th, 12-5 EST

Hello colleagues,

The FDA Foundation/NIDA is asking for public input on a practical research agenda towards treatment development for stimulant use disorder. They are hosting a workshop on October 18 12:00-5:00 EST titled "A Practical Research Agenda for Treatment Development for Stimulant Use Disorder, Virtual Public Workshop"

More information about the workshop is available here: https://reaganudall.org/news-and-events/events/practical-research-agenda-treatment-development-stimulant-use-disorder

and the agenda is available here and pasted below: https://reaganudall.org/sites/default/files/2021-10/REVISED%2010.5.2021%20Workshop%20Agenda.pdf

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Event Description: The Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food
and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), is hosting a virtual
public workshop to discuss a practical research agenda toward treatment development for
stimulant use disorder. Stimulant use disorder is defined in the DSM-5 as "the continued use of
amphetamine-type substances, cocaine, or other stimulants leading to clinically significant
impairment or distress, from mild to severe." Adverse outcomes related to stimulant use are a
growing problem in the United States.1,2 There are currently no effective pharmacological
treatments for any type of stimulant use disorder. However, there are many opportunities to
improve the study design of clinical trials for stimulant use disorder. Clinical trials that are more
person-centered may result in increased sensitivity to detect a treatment effect, with the potential
for such a treatment effect to be linked to more long-term outcomes that are meaningful both
clinically and to the patient.3 Meeting participants will respond to a proposed practical research
agenda that focuses on innovation in clinical trial design and candidate endpoints for the
evaluation of potential treatments for stimulant use disorder.

12 p.m. Welcome
Susan Winckler, Reagan-Udall Foundation for the FDA

12:05 p.m. Session 1: Efforts to Promote Treatment Development for Stimulant Use Disorder
• Janet Woodcock, U.S. Food and Drug Administration
• Nora Volkow, National Institute on Drug Abuse

12:45 p.m. Session 2: Optimizing Clinical Trial Design for Stimulant Use Disorder
Presenters
• David McCann, National Institute on Drug Abuse
• Madhukar Trivedi, UT Southwestern

Panelists
• Frances Levin, Columbia University
• Jessica Hulsey, Addiction Policy Forum
• Sarah Akerman, Alkermes
• Maria Sullivan, Pear Therapeutics
• Robert Walsh, National Institute on Drug Abuse
• Maryam Afshar, U.S. Food and Drug Administration

Discussion

2:15 p.m. Break

2:30 p.m. Session 3: Identifying Clinically Meaningful and Patient-Centric Endpoints
Presenters
• Brian Kiluk, Yale School of Medicine

Panelists
• Deborah Hasin, Columbia University
• Michelle Peavy, University of Washington
• Philip Rutherford, Faces and Voices of Recovery
• Ivan Montoya, National Institute on Drug Abuse
• David Reasner, U.S. Food and Drug Administration
• Celia Winchell, U.S. Food and Drug Administration

Discussion

4 p.m. Session 4: Future Directions for Stimulant Use Disorder Research
Panelists
• Marta Sokolowska, U.S. Food and Drug Administration
• Nora Volkow, National Institute on Drug Abuse
• F. Gerald Moeller, Virginia Commonwealth University
• Brandee Izquierdo, SAFE Project
• Nicole Caffiero, Cigna
• Denise Leclair, Novartis

Discussion

4:50 p.m. Closing Remarks

5 p.m. Adjournment 

Warm regards

Kelly

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Kelly Dunn, Ph.D., M.B.A.

President, Division on Psychopharmacology and Substance Use (Division 28)

American Psychological Association

Associate Professor
Behavioral Pharmacology Research Unit
Department of Psychiatry and Behavioral Sciences
Johns Hopkins School of Medicine
5510 Nathan Shock Drive
Baltimore, MD 21224
P:410-550-2254; F:410-550-0030