MedTrace Logo

Dose Optimization of MDMA-Assisted Therapy for PTSD

NCT06418178 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-26

No results posted yet for this 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.

Conditions

Interventions

DRUG

Midomafetamine

One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)

BEHAVIORAL

Psychotherapy

Standardized psychotherapy performed by therapy team

Sponsors & Collaborators

  • Bronx VA Medical Center

    lead FED

Principal Investigators

  • Rachel Yehuda, PhD · James J. Peters VA Medical Center

  • Amy Lehrner, PhD · James J. Peters VA Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418178 on ClinicalTrials.gov