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NCT05219175 · ClinicalTrials.gov registry record · Phase 2
MDMA for Co-occurring PTSD and OUD After Childbirth
A Phase 2 study of Opioid Use Disorder and Stress Disorders, Post-Traumatic, sponsored by University of New Mexi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05219175: Recruiting Phase 2 study of Opioid Use Disorder and Stress Disorders, Post-Traumatic, sponsored by University of New Mexi.
NCT05219175 is a Phase 2 study of Opioid Use Disorder and Stress Disorders, Post-Traumatic that is actively recruiting participants, run by University of New Mexi. The registered enrollment target is 15 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05219175, a Phase 2 study of Opioid Use Disorder and Stress Disorders, Post-Traumatic, is actively recruiting participants, sponsored by University of New Mexi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
CAPS-5
Conditions Studied
Interventions
- DRUG MDMA Assisted Therapy
Study Locations (1)
New Mexico
- University of New Mexico Health Sciences - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT05219175 shows while recruiting
NCT05219175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which MDMA Assisted Therapy is the first listed.
NCT05219175 reports a single indexed study location in New Mexico.
Frequently Asked Questions
What is clinical trial NCT05219175 about?
NCT05219175 is a clinical study titled "MDMA for Co-occurring PTSD and OUD After Childbirth". 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 Stu...
What is the current status of trial NCT05219175?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2024-04-16. Estimated completion is 2027-11.
What conditions does trial NCT05219175 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Stress Disorders, Post-Traumatic.
What interventions are being tested in trial NCT05219175?
The interventions under investigation include: MDMA Assisted Therapy (DRUG).
Who is sponsoring clinical trial NCT05219175?
This trial is sponsored by University of New Mexi, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05219175 being conducted?
This trial has 1 study location across New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05219175's enrollment target sits among peer trials
15 242nd of 257 higher than 11 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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