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MDMA-AT for PTSD in Young Adults With Childhood Trauma

NCT07765693 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-14

No results posted yet for this study

Summary

This study is testing a new, emerging treatment for young adults (ages 18-26) with Posttraumatic Stress Disorder (PTSD). The treatment is combining the substance, MDMA, with up to three psychotherapy sessions, also known as MDMA-Assisted Therapy (MDMA-AT).

The main questions it aims to answer are:

* Is the treatment safe and feasible to administer?
* Does the treatment improve PTSD symptoms?

Participants will be asked to:

* Complete screening procedures, including a medical and psychiatric evaluation to ensure safe participation
* Attend up to three preparatory talk therapy sessions prior to the first MDMA-AT dosing session
* Attend three integration talk therapy sessions after each MDMA-AT dosing session
* Attend up to three total MDMA-AT dosing sessions
* Complete assessments from baseline to 38-weeks post-baseline
* Complete a fMRI scan at baseline and at 18-weeks post-treatment
* Complete self-report measures and ecological momentary assessments (EMAs) across the study period

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Interventions

DRUG

MDMA assisted psychotherapy

Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.

Sponsors & Collaborators

  • Jenna M. Traynor

    lead OTHER

Principal Investigators

  • Jenna M Traynor · Mclean Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-01-30
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07765693 on ClinicalTrials.gov