MDMA for Co-occurring PTSD and OUD After Childbirth

This open-label trial (n=15) will assess the effectiveness of MDMA-assisted therapy (MDMA-AT) for individuals experiencing both Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD) in the postpartum period.

Conducted by the University of New Mexico, the study aims to explore the feasibility and safety of using MDMA-AT to treat PTSD in this population. Participants must be at least 18 years old, have stable opioid use for at least three months, and meet specific criteria for PTSD and OUD.

The primary outcome measure will be PTSD severity assessed by the CAPS-5 four weeks after the third experimental session. Secondary outcomes include assessing opioid use disorder using the Timeline Follow-Back six months after the third experimental session. The study is anticipated to start in March 2024 and conclude in November 2025.

Trial Details

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.

NCT Number NCT05219175

Data attribution

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