MDMA-assisted psychotherapy in the treatment of trauma
An open-label, single-arm pilot study in Brazil investigating MDMA-assisted psychotherapy for adults with moderate-to-severe PTSD. Three participants received up to three MDMA sessions (75–125 mg) within a structured protocol of preparatory and integration therapy sessions, following the MAPS treatment model.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted psychotherapy
experimentalParticipants received MDMA orally across three monthly sessions. Initial dose was 75 mg with an optional supplemental dose of 37.5 mg offered 90–120 min later. Dose could be escalated to 125 mg (with 62.5 mg supplement) in subsequent sessions. Each dosing session was flanked by preparatory and integration psychotherapy.
Interventions
- MDMA75 - 125 mgvia Oral• Monthly, 3 sessions total• 3 doses total
Supplemental dose of 50% the initial dose offered 90–120 min after initial administration (37.5 mg or 62.5 mg). Participants ultimately received total MDMA amounts of 112.5 mg and 187.5 mg across sessions.
Participants
Inclusion Criteria
- Adults aged 18–70 with a DSM-IV PTSD diagnosis confirmed by Structured Clinical Interview (SCID); CAPS-4 score ≥60; at least one prior treatment failure; Portuguese fluency; willingness to discontinue psychiatric medications and recreational drugs during the study; minimum 8th-grade education; commitment to protocol adherence.
Exclusion Criteria
- Pregnancy or potentially fertile women not using contraceptives; primary psychotic disorder; bipolar disorder type 1 or personality disorder; uncontrolled hypertension; history of coronary artery disease or vascular disease; hepatic disease; weight <48 kg; active suicide risk; prior ecstasy use >10 times in 10 years; active substance abuse disorders.