MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
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 psychotherapy and one
therapist trained and experienced in CBCT. During the first experimental session, both
participants will receive 75 mg of MDMA 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 MDMA 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 CAPS-5 total severity
scores in PTSD participants.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies