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NCT03282123 · ClinicalTrials.gov registry record · Phase 2
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
A Phase 2 study of PTSD, sponsored by Lykos Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 12
- Study locations
NCT03282123 is a Phase 2 study of PTSD that has completed, run by Lykos Therapeutics. The registered enrollment target is 38 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (87% lower). The trial reports 12 study locations across 8 states.
The verdict
NCT03282123, a Phase 2 study of PTSD, has completed, sponsored by Lykos Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 12
- Study locations
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.
Conditions Studied
Interventions
- DRUG Midomafetamine
- BEHAVIORAL Manualized therapy
Study Locations (12)
California
- New School Research LLC - North Hollywood
- San Francisco Insight and Integration Center - San Francisco
- University of California San Francisco - San Francisco
Colorado
- Aguazul-Blue Water Inc. - Boulder
- Wholeness Center - Fort Collins
New York
- New York University - New York
- Affective Care - New York
Connecticut
- University of Connecticut - Farmington
Louisiana
- Ray Worthy Psychiatry LLC - New Orleans
Massachusetts
- Trauma Research Foundation - Brookline
South Carolina
- Zen Therapeutic Solutions, LLC - Mt. Pleasant
Wisconsin
- University of Wisconsin at Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2019-08-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03282123
The ClinicalTrials.gov registry entry for NCT03282123 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (87% lower). The listed sponsor is Lykos Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Midomafetamine is the first listed.
NCT03282123 reports 12 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT03282123 about?
NCT03282123 is a clinical study titled "Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug pre...
What is the current status of trial NCT03282123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2017-11-16. Estimated completion is 2019-08-10.
What conditions does trial NCT03282123 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT03282123?
The interventions under investigation include: Midomafetamine (DRUG), Manualized therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03282123?
This trial is sponsored by Lykos Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03282123 being conducted?
This trial has 12 study locations across California, Colorado, Connecticut, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.