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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s or Agency’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications for 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. This draft guidance is intended to serve as a focus for continued discussions among Center for Drug Evaluation and Research staff (particularly the Division of Anesthesiology, Addiction Medicine, and Pain Medicine, or the division), pharmaceutical sponsors, the academic community, and the public. This guidance does not address treatment of intoxication or poisoning with various stimulants or treatment of withdrawal from stimulants.