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MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

Not yet recruitingRegisteredCTG

This randomized, double-blind, single-site Phase II trial (n=40) will investigate MDMA-assisted therapy’s safety and preliminary efficacy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in veterans with at least moderate PTSD severity.

Details

Randomized, double-blind, single-site Phase II trial in up to 40 veterans comparing MDMA-assisted therapy versus low-dose d-amphetamine-assisted therapy with 1:1 allocation and stratification by gender.

Procedures include screening and baseline CAPS-5, three preparatory therapy sessions, three experimental dosing sessions (flexible divided doses) each followed by an integration session, and follow-up assessments including CAPS-5 for the primary outcome.

Topics:PTSD

Registry

Registry linkNCT05790239