Open-label, within-subjects dose optimisation trial (n=60) in U.S. veterans with PTSD investigating the optimal number of MDMA-Assisted Therapy cycles (one MDMA session + three integration sessions).
Open-label, single-group dose-optimisation study in U.S. veterans with PTSD. All participants receive three preparatory psychotherapy sessions and at least one MDMA-assisted therapy cycle; participants may receive up to five cycles.
Each cycle comprises one approximately eight-hour MDMA dosing session (120 mg initial dose with optional 60 mg supplemental dose) followed by three 90-minute integrative psychotherapy sessions with a two-therapist team.
After each cycle participants and therapists jointly decide whether to continue based on symptom change, tolerability, and burden; blood samples are collected and banked for future biomarker analyses.
Open-label, within-subjects treatment arm. Participants receive 120 mg + optional 60 mg supplement MDMA; one to five dosing sessions three to five weeks apart; each dosing session followed by three integration psychotherapy sessions.
120 mg initial dose with optional 60 mg supplemental dose; 1–5 MDMA-assisted therapy sessions per participant.
Standardised psychotherapy by a team of two therapists: three preparatory sessions before first dosing and three 90-minute integrative sessions after each dosing session.