Stimulant Use Disorder – New Draft FDA Guidance and Resource


Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability was announced by The U.S. Food and Drug Administration (FDA) in a press release. There are currently no FDA-approved medications for treating Stimulant Use Disorder (SUD). The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of SUDs. Specifically, this guidance addresses FDA's current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications of treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder.

The FDA has opened this draft guidance for public comments, which are due by December 4, 2023. 

In addition, the National Association of State Alcohol and Drug Abuse Directors (NASADAD) recently released a fact sheet on methamphetamine, which updates a fact sheet previously released in 2015. This document includes an overview and information on the public health impact, treatment options, and geographic trends of methamphetamine. It also provides a list of key Federal programs and agencies and speaks to the role of those agencies in prevention, treatment, and recovery.

For more information on stimulant use disorder, see the AHRQ Academy’s Stimulant Use Disorders Topic Brief and their variety of tools and resources pertaining to SUD. Also, see the FDA page on Prescription Stimulant Medications.