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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: Completed Phase 2 study of PTSD, sponsored by Lykos Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
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 |
What the finished NCT03282123 record still lists
NCT03282123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (87% lower).
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 lists 12 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for PTSD
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 NCT03282123's enrollment target sits among peer trials
38 115th of 154 higher than 40 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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