MDMA for Co-occurring PTSD and OUD After Childbirth
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.
Detailed Description
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.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted therapy
experimentalOpen-label MDMA-assisted therapy (three monthly experimental sessions with preparatory and integrative therapy).
Interventions
- MDMA100 - 180 mgvia Oral• three sessions• 3 doses total
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.
Participants
Inclusion Criteria
- Inclusion Criteria:
- 1. Age ≥18 years.
- 2. Meet DSM-5 criteria for Opioid Use Disorder and be on stable MOUD (oral methadone ≤180 mg daily or sublingual buprenorphine ≤24 mg) for ≥3 months.
- 3. Meet DSM-5 criteria for current moderate to severe PTSD (CAPS-5 ≥28; PCL-5 ≥40) with symptoms ≥3 months.
- 4. Fluent in English; able to swallow pills; agree to study procedures and recording.
- 5. Provide a contact person reachable if participant becomes suicidal or unreachable.
- 6. If able to become pregnant: negative pregnancy test at entry and prior to each experimental session and agree to effective contraception through 10 days after last session.
- 7. May have stable, treated medical comorbidities (e.g., treated hypertension, stable diabetes, treated HCV) with physician approval.
- 8. Weight ≥48 kg.
Exclusion Criteria
- Exclusion Criteria (selected):
- 1. Unable to give informed consent or prisoner status.
- 2. Likely to be re-exposed to index trauma, lack social support, or unstable housing per investigator judgment.
- 3. Current primary psychotic disorder, bipolar I disorder, dissociative identity disorder, or current eating disorder with active purging.
- 4. Current moderate/severe alcohol or cannabis use disorder (not in early remission) or active illicit (other than cannabis or opioids) or prescription drug use disorder within 3 months.
- 5. Recent ECT (within 12 weeks).
- 6. Significant cardiac risk including QTc >460 ms or other torsade risk factors; symptomatic liver disease or significant LFT elevations; history of hyponatraemia or hyperthermia.
- 7. Use of concomitant QT-prolonging medications during experimental sessions.
- 8. Pregnant or breastfeeding; inability to comply with contraception requirements.