MDMA for Co-occurring PTSD and OUD After Childbirth
Trial Parameters
Brief Summary
This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment. This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.
Eligibility Criteria
Inclusion Criteria: * Potential participants are eligible to enroll in the protocol if they: 1. Are at least 18 years old. 2. Have opioid use disorder and are using daily oral methadone of 180 mg or less, or sublingual buprenorphine (or buprenorphine with naloxone in 4:1 ratio) of 24 mg or less. Assessed as stable for at least 3 months based upon review of the University of New Mexico Milagro and FOCUS program medical records or direct communication with the participant's buprenorphine or methadone prescriber. 3. Are fluent in speaking and reading English. This criteria is needed as the protocol requires two therapists that have specific training and it would be very difficult to identify two therapists fluent in another language 4. Are able to swallow pills. 5. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments by an on-site Independent Rater for CAPS-5, and non-drug therapy sessions. 6. Must provide a contact (relative, spouse, close f