RecruitingPhase 2NCT05219175

MDMA for Co-occurring PTSD and OUD After Childbirth

MDMA-Assisted Therapy 6 to 12 Months After Childbirth for People With Co-occurring Opioid Use and Post Traumatic Stress Disorders


Sponsor

University of New Mexico

Enrollment

15 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing MDMA-assisted therapy for women who developed both PTSD (post-traumatic stress disorder) and opioid use disorder (OUD) around the time of childbirth. MDMA (also known as ecstasy) is being studied as a medicine that, when used in a controlled therapeutic setting with trained therapists, may help people process trauma more effectively. **You may be eligible if...** - You are at least 18 years old - You have opioid use disorder and are stable on methadone (180 mg or less) or buprenorphine (24 mg or less) for at least 3 months - You have moderate to severe PTSD symptoms (score of 40 or higher on the PCL-5 scale) lasting at least 3 months - You are fluent in English - You have a support person (friend or family member) the research team can contact if needed **You may NOT be eligible if...** - You have a history of bipolar disorder type 1, primary psychotic disorder, or dissociative identity disorder - You have severe or unstable alcohol use disorder or active substance use disorder (other than opioids or mild cannabis use) - You have serious cardiovascular problems, uncontrolled high blood pressure, or a history of heart rhythm problems - You have severe liver disease - You weigh less than 48 kg - You are pregnant or not using effective birth control Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDMA Assisted Therapy

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)


Locations(1)

University of New Mexico Health Sciences

Albuquerque, New Mexico, United States

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NCT05219175


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