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MDMA for Co-occurring PTSD and OUD After Childbirth

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv11
  2. Notable Trial status: Active, Not Recruiting to Recruiting Site details revisedv10 Show 1 more changeShow less
    • Site details revised
  3. Notable Primary completion date: Apr 2025 to Apr 2027 Completion date: Nov 2025 to Nov 2027v9 Show 1 more changeShow less
    • Completion date: Nov 2025 to Nov 2027
  4. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 1, 2024 to Apr 16, 2024v8 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2024 to Apr 16, 2024
  5. Notable Start date: Jan 1, 2024 to Mar 1, 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Start date: Nov 1, 2023 to Jan 1, 2024v6
  2. Notable Start date: Aug 1, 2023 to Nov 1, 2023v5
  3. Notable Start date: Mar 1, 2023 to Aug 1, 2023v4
  4. Notable Primary completion date: May 2024 to Apr 2025 Completion date: Oct 2024 to Nov 2025 · Start date: Feb 1, 2023 to Mar 1, 2023 · Eligibility criteria shortened, about 195 words · 1 morev3 Show 4 more changesShow less
    • Completion date: Oct 2024 to Nov 2025
    • Start date: Feb 1, 2023 to Mar 1, 2023
    • Eligibility criteria shortened, about 195 words
    • Study description expanded, about 36 words

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Start date: May 1, 2022 to Feb 1, 2023 Eligibility criteria shortened, about 178 words · Study description shortened, about 83 words · Collaborators expanded, about 5 words · 1 morev2 Show 4 more changesShow less
    • Eligibility criteria shortened, about 178 words
    • Study description shortened, about 83 words
    • Collaborators expanded, about 5 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
821 trials monitored
See 49 trials at risk
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.
Trial Details
NCT Number NCT05219175
Lead Sponsor University of New Mexico
Collaborators: Multidisciplinary Association for Psychedelic Studies
Conditions Stress Disorders, Post-Traumatic, Opioid Use Disorder
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov