Dose Optimization of MDMA-Assisted Therapy for PTSD

Part of paid clinical trials in The Bronx, New York.

Sponsor
Bronx VA Medical Center
Study ID
NCT06418178
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Midomafetamine — DRUG
    One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)
  • Psychotherapy — BEHAVIORAL
    Standardized psychotherapy performed by therapy team

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jun 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Open label, within-subjects treatment arm. Participants receive 120mg + optional 60mg supplement. There will be from one to five dosing sessions that occur three to five weeks apart. Each dosing session is followed by three integration psychotherapy sessions.

Primary Outcome Measure

PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical CenterThe BronxNew York10468
Joshua Park
[email protected]
9297363104

Find similar trials in The Bronx, NY

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
James J. Peters VA Medical Center· The Bronx, NY

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