Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05219175

MDMA for Co-occurring PTSD and OUD After Childbirth

Led by University of New Mexico · Updated on 2026-03-16

15

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

Sponsors

U

University of New Mexico

Lead Sponsor

M

Multidisciplinary Association for Psychedelic Studies

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MDMA for Co-occurring PTSD and OUD After Childbirth

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Have opioid use disorder and be stable on daily oral methadone (180 mg or less) or sublingual buprenorphine (24 mg or less) for at least 3 months
  • Fluent in speaking and reading English
  • Able to swallow pills
  • Agree to have study visits recorded including therapy and assessments
  • Provide a contact person reachable if participant becomes suicidal or unreachable
  • Agree to inform investigators of any medical conditions or procedures within 48 hours
  • If able to become pregnant, have a negative pregnancy test at entry and before each experimental session
  • Agree to use effective birth control through 10 days after the last experimental session
  • Meet DSM-5 criteria for current moderate to severe PTSD lasting 6 months or longer
  • Meet DSM-5 criteria for opioid use disorder
  • Have PTSD symptoms for at least 3 months with a PCL-5 score of 40 or greater in the last month
  • May have well-controlled hypertension if cardiovascular disease is ruled out
  • May have asymptomatic Hepatitis C virus if treated as needed
  • Have at least moderate PTSD symptoms at baseline with CAPS-5 score of 28 or greater
  • May have mild or moderate alcohol or cannabis use disorder in early remission
  • May have stable diabetes mellitus (Type 2) with physician approval
  • May have hypothyroidism if on stable thyroid medication
  • May have history or current glaucoma with ophthalmologist approval
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Prisoners
  • Likely to be re-exposed to trauma, lack social support, or lack stable housing
  • Any current problem interfering with participation
  • QTc interval greater than 460 msec on EKG screening or within 72 hours of treatment sessions
  • Received Electroconvulsive Therapy within 12 weeks prior to enrollment
  • History or current primary psychotic disorder, bipolar disorder 1, or dissociative identity disorder
  • Current eating disorder with active purging
  • Major depressive disorder with psychotic features
  • Moderate or severe alcohol or cannabis use disorder within 6 months prior to enrollment
  • Active illicit or prescription drug use disorder (other than cannabis or opioids) within 3 months prior
  • Recent moderate or severe cannabis use disorder not tapered off before enrollment
  • Current Cluster A personality disorders
  • High risk of adverse emotional or behavioral reactions or lack of social support
  • Current serious suicide risk or likely need for hospitalization due to suicidality
  • Medical conditions making sympathomimetic drug use harmful
  • Uncontrolled hypertension assessed on three occasions
  • History of ventricular arrhythmia or arrhythmias within 12 months
  • Additional risk factors for Torsade de pointes
  • Use of medications that prolong QT/QTc interval during sessions
  • Symptomatic liver disease or significant liver enzyme elevations
  • History of hyponatremia or hyperthermia
  • Weight below 48 kilograms
  • Pregnant or able to become pregnant without effective birth control

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of New Mexico Health Sciences

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

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Research Team

L

Lawrence M Leeman, MD MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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