Phase I/II, single-group, open-label study (n=12 dyads) combining CBCT with two MDMA-assisted therapy sessions (75–100 mg, optional supplemental half-doses) to assess safety and change in PTSD symptoms in participants with chronic PTSD and their partners.
This single-group Phase I/II study evaluated MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in dyads where one member has chronic PTSD. Participants completed three preparatory sessions, two MDMA-assisted sessions, and multiple integrative CBCT sessions.
MDMA dosing: session 1 initial 75 mg with optional 37.5 mg supplement; session 2 initial 75 or 100 mg with optional 37.5 mg or 50 mg supplement. Outcomes included CAPS-5 change and safety/tolerability measures.
Cognitive-behavioral conjoint therapy combined with two MDMA-assisted therapy sessions (single-group, open-label).
Session 1: 75 mg initial with optional supplemental 37.5 mg 1.5–2 h later. Session 2: initial 75 or 100 mg with optional supplemental 37.5 mg or 50 mg respectively.
CBCT behavioural intervention (15-session manualised CBCT delivered alongside MDMA-assisted therapy).