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The present article explores ethical considerations related to 3,4-methylenedioxymethamphetamine (MDMA)–assisted therapy (MDMA-AT) as a potential treatment for posttraumatic stress disorder. The authors focus on U.S. Food and Drug Administration regulatory challenges associated with evaluating MDMA and psychotherapy in conjunction and the role that a risk evaluation in management mitigation program may play in assessing risks and benefits of MDMA-AT. Also discussed are workforce considerations, including foreseeable training requirements, and concerns related to off-label use. The authors emphasize the need for continued research, careful regulation, and thorough clinician education to realize the therapeutic potential of MDMA while ensuring patient safety.
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Hartstein et al. (2024) studied this question.
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