This open-label trial (n=15) will assess feasibility, safety and preliminary efficacy of MDMA-assisted therapy (three monthly MDMA sessions with preparatory and integrative therapy) for postpartum people with co-occurring PTSD and Opioid Use Disorder.
Single-site, open-label feasibility study assessing MDMA-assisted therapy for people 6–12 months postpartum with co-occurring PTSD and opioid use disorder on stable MOUD; primary outcome is CAPS-5 change at 1 month after the last session.
Intervention: three monthly experimental MDMA sessions (initial session 100 mg MDMA HCl with optional 40 mg supplemental at 2 hours; sessions 2–3 may use 120 mg + 60 mg supplemental), preceded by preparatory sessions and followed by integrative therapy.
Secondary and exploratory assessments include opioid use (TLFB), maternal–infant attachment (Still Face Paradigm and questionnaires), social connectedness, and other mental health measures; qualitative interviews will be conducted post-treatment.
Study site: University of New Mexico Health Sciences Center, Albuquerque, NM; therapy teams trained in MAPS MDMA-assisted therapy manual with adjunctive MI, ACT, and mindfulness-informed approaches.
Open-label MDMA-assisted therapy (three monthly experimental sessions with preparatory and integrative therapy).
Initial session: 100 mg MDMA HCl (~80 mg MDMA) + optional supplemental 40 mg at 2 h; sessions 2–3 may use 120 mg + 60 mg supplemental; cumulative MDMA HCl 340–500 mg.