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NCT05943665 · ClinicalTrials.gov registry record · Phase 2
MDMA for AUD/PTSD Comorbidity
A Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress Disorder, sponsored by Carolina L Haass-Koffler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05943665 is a Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress Disorder that is actively recruiting participants, run by Carolina L Haass-Koffler. The registered enrollment target is 18 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05943665, a Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05943665
The ClinicalTrials.gov registry entry for NCT05943665 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Carolina L Haass-Koffler, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which MDMA is the first listed.
NCT05943665 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Alcohol Use Disorder, Post Traumatic Stress 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.
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