Testing a new therapy approach for trauma and opioid recovery after childbirth

Plain-English translation of NCT05219175 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This trial is testing a new treatment approach that combines MDMA (a medication being studied for trauma recovery) with specialized therapy sessions. The study is designed for people who are struggling with both post-traumatic stress disorder (PTSD) and opioid use disorder (OUD), particularly those who gave birth within the past 6–12 months. Researchers want to see if this medication, paired with professional therapeutic support, can help reduce PTSD symptoms and support long-term recovery from opioid use.

Many people who struggle with opioid addiction have experienced serious trauma in their lives, and treating both conditions together is challenging with current approaches. This medication shows early promise in helping people process trauma and heal, and this trial aims to see whether it could help improve outcomes for pregnant and postpartum people who are on stable opioid treatment and dealing with PTSD.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with opioid use disorder and are on a stable daily dose of methadone (180 mg or less) or buprenorphine (24 mg or less) for at least 3 months
you have been diagnosed with moderate to severe post-traumatic stress disorder lasting at least 6 months
you are fluent in English (speaking and reading)
you are able to swallow pills and willing to have study sessions recorded
you can identify a trusted support person (family member, friend, or partner) willing to be contacted by the research team if needed

You likely don't qualify if…

you are pregnant or unable to use reliable birth control for 10 days after the last treatment session
you have serious heart problems or uncontrolled high blood pressure
you are currently using other opioids outside of your prescribed medication
you have active suicidal plans or severe untreated mental health conditions
you cannot commit to attending multiple therapy and medication sessions over several months

What participation looks like

If you join this trial, you will attend three main treatment sessions spaced over several weeks, each combining the study medication with several hours of therapy with trained therapists. Between sessions, you'll have regular therapy appointments without the medication to process what you've learned. You'll also complete several assessments—questionnaires and interviews—to measure how your PTSD and opioid use symptoms change over time. The entire program lasts several months, and the research team will stay in touch to monitor your progress and safety.

Testing a new therapy approach for trauma and opioid recovery after childbirth

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)