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NCT05943665 · ClinicalTrials.gov registry record · Phase 2
MDMA for AUD/PTSD Comorbidity
A Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by Carolina L Haass-Koffler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05943665: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by Carolina L Haass-Koffler.
NCT05943665 is a Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder that is actively recruiting participants, run by Carolina L Haass-Koffler. The registered enrollment target is 18 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05943665, a Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, is actively recruiting participants, sponsored by Carolina L Haass-Koffler.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.
Primary Outcome
Amount of alcohol consumed
Conditions Studied
Interventions
- DRUG MDMA
Study Locations (1)
Rhode Island
- Brown University - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-02-06 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 2 |
What NCT05943665 shows while recruiting
NCT05943665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which MDMA is the first listed.
NCT05943665 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05943665 about?
NCT05943665 is a clinical study titled "MDMA for AUD/PTSD Comorbidity". The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists...
What is the current status of trial NCT05943665?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2024-02-06. Estimated completion is 2026-01-30.
What conditions does trial NCT05943665 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Alcohol Use Disorder.
What interventions are being tested in trial NCT05943665?
The interventions under investigation include: MDMA (DRUG).
Who is sponsoring clinical trial NCT05943665?
This trial is sponsored by Carolina L Haass-Koffler, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05943665 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05943665's enrollment target sits among peer trials
18 242nd of 262 higher than 19 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress 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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