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MDMA Plus Exposure Therapy for PTSD
RecruitingRegisteredCTG
This Phase IV interventional trial (n=40) aims to investigate the efficacy and safety of MDMA (84-100mg) in combination with Prolonged Exposure therapy (PE) for individuals with posttraumatic stress disorder (PTSD).
Details
Open-label, single-group study of MDMA combined with massed Prolonged Exposure therapy in people meeting criteria for PTSD; a single Medicine Session with MDMA occurs on Day 2 of a 10-day PE programme.
Primary outcomes assess feasibility, safety and PTSD symptom change; exploratory psychophysiological and optional fMRI measures will probe mechanisms of treatment response. Participants are followed up at 1, 2 and 4 weeks and 6 months after treatment.
Topics:PTSD
Registry
Registry linkNCT05746572