MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA-assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of midomafetamine HCl will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.