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NCT06117306 · ClinicalTrials.gov registry record · Phase 3
MDMA-assisted Massed Prolonged Exposure for PTSD
A Phase 3 study of Post Traumatic Stress Disorder, sponsored by Healing Breakthrough.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06117306: Recruiting Phase 3 study of Post Traumatic Stress Disorder, sponsored by Healing Breakthrough.
NCT06117306 is a Phase 3 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Healing Breakthrough. The registered enrollment target is 20 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
NCT06117306, a Phase 3 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Healing Breakthrough.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores rang
Conditions Studied
Interventions
- BEHAVIORAL Prolonged Exposure
- DRUG 3,4 Methylenedioxymethamphetamine
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-25 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 3 |
What NCT06117306 shows while recruiting
NCT06117306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Prolonged Exposure is the first listed.
NCT06117306 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06117306 about?
NCT06117306 is a clinical study titled "MDMA-assisted Massed Prolonged Exposure for PTSD". The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive different doses of MDMA.
What is the current status of trial NCT06117306?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2024-10-25. Estimated completion is 2026-01-01.
What conditions does trial NCT06117306 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT06117306?
The interventions under investigation include: Prolonged Exposure (BEHAVIORAL), 3,4 Methylenedioxymethamphetamine (DRUG).
Who is sponsoring clinical trial NCT06117306?
This trial is sponsored by Healing Breakthrough, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06117306 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
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 NCT06117306's enrollment target sits among peer trials
20 231st of 262 higher than 22 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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