- October 18, 2021
- 12:00 PM - 5:00 PM ET
Date: October 18, 2021, 12 - 5 PM ET
Attend the workshop:
The U.S. Food and Drug Administration (FDA), in partnership with the Reagan-Udall Foundation for the FDA and the National Institute on Drug Abuse, will hold a virtual public workshop entitled "A Practical Research Agenda for 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 and there are currently no FDA approved 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 treatment effects to be linked to more long-term outcomes that are meaningful both clinically and to the patient.
This virtual public workshop will allow stakeholders to provide input on 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.