MDMA Assisted Therapy for PTSD and Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of New Mexico

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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

This trial is for postpartum individuals at least 18 years old with PTSD and OUD, using a stable dose of methadone or buprenorphine. Participants must speak English, be able to swallow pills, consent to recorded sessions, provide an emergency contact, inform investigators about medical changes, and use effective birth control if applicable.

Inclusion Criteria

I am not pregnant and agree to use birth control during the study.

Participants must be able to swallow pills

Participants must provide a contact person who is willing and able to be reached in case of emergencies

+6 more

Exclusion Criteria

I am unable to understand or sign the consent form.

Prisoners

Participants likely to be re-exposed to their index trauma, lack social support, or lack a stable living situation

+4 more

Participant Groups

The study tests MDMA Assisted Therapy's feasibility and safety in treating PTSD in those with OUD after childbirth. It adapts from Phase 3 studies by MAPS for PTSD treatment. Outcomes include the CAPs 5 for PTSD and TLFB for opioid use; other mental health outcomes are also explored.

1Treatment groups

Experimental Treatment

Group I: Co-occurring PTSD and OUD prior and after treatment with MDMA Assisted TherapyExperimental Treatment1 Intervention

The intervention is MDMA Assisted Therapy focused on PTSD and three experiment sessions with the first session using an initial dose of 100 mg MDMA HCL (\~80 mg MDMA) with supplemental dose of 40 mg MDMA HCL (\~35 mg MDMA). Total dose range for the first session is 100 mg MDMA HCL (\~80 mg MDMA) to 140 mg MDMA HCL (\~115 mg MDMA).The second and third sessions may use an initial dose of 120 mg MDMA HCL (\~100 mg MDMA) with a supplemental dose of 60 mg MDMA HCL (\~50 mg MDMA) for a total dose range of 120 mg MDMA HCL (\~100 mg MDMA) to 180 mg MDMA HCL (\~160 mg MDMA) Total cumulative dose range for the three sessions is 340mg MDMA HCL (\~280 mg MDMA) to 500 mg MDMA HCL (\~435 mg MDMA)

MDMA is already approved in United States for the following indications:

🇺🇸 Approved in United States as MDMA for: