This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Open-label, single-group Phase II study of a single full-dose MDMA-assisted therapy session (125 mg followed by 62.5 mg 1.5–2.5 hours later) for up to three participants with relapsed PTSD after prior MDMA-assisted therapy.
Participants receive one preparatory therapy session, the MDMA session with overnight clinic stay and monitoring of vital signs and psychological distress, and three post-session integrative therapy sessions; outcomes assessed at baseline, 2 months and 12 months.
Single full-dose MDMA-assisted therapy session with preparatory and integrative non-drug therapy sessions.
Second dose 62.5 mg given 1.5–2.5 hours after initial 125 mg.