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NCT06418178 · ClinicalTrials.gov registry record · Phase 2

Dose Optimization of MDMA-Assisted Therapy for PTSD

A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Bronx VA Medical Center.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06418178: Recruiting Phase 2 study of Post Traumatic Stress Disorder, sponsored by Bronx VA Medical Center.

NCT06418178 is a Phase 2 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Bronx VA Medical Center. The registered enrollment target is 60 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06418178, a Phase 2 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Bronx VA Medical Center.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

Primary Outcome

The PCL-5 is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms per DSM-5. Participants indicate how much distress they have experienced due to each symptom on a five-point Likert-type scale (1=Not at all to 5=Extremely).

Interventions

  • BEHAVIORAL Psychotherapy
  • DRUG Midomafetamine

Study Locations (1)

New York

  • James J. Peters VA Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-06-03
Est. Completion 2029-10
Phase Phase 2
Bronx VA Medical Center

13 total trials

What NCT06418178 shows while recruiting

NCT06418178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Psychotherapy is the first listed.

NCT06418178 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT06418178 about?

NCT06418178 is a clinical study titled "Dose Optimization of MDMA-Assisted Therapy for PTSD". This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

What is the current status of trial NCT06418178?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-06-03. Estimated completion is 2029-10.

What conditions does trial NCT06418178 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder.

What interventions are being tested in trial NCT06418178?

The interventions under investigation include: Psychotherapy (BEHAVIORAL), Midomafetamine (DRUG).

Who is sponsoring clinical trial NCT06418178?

This trial is sponsored by Bronx VA Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06418178 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT06418178's enrollment target sits among peer trials

60 160th of 262 higher than 96 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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Source: ClinicalTrials.gov NCT06418178, the US trial registry maintained by the National Library of Medicine. NCT06418178 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.