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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.

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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.

Interventions

  • DRUG MDMA

Study Locations (1)

Rhode Island

  • Brown University - Providence

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2024-02-06
Est. Completion 2026-01-30
Phase Phase 2

Sponsor

Carolina L Haass-Koffler

1 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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