MDMA-AT for PTSD in Young Adults With Childhood Trauma

NCT07765693 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2026P000839
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Young adults; Ages 18-26; MDMA; Posttraumatic Stress Disorder; PTSD

Outcome Measures

Primary Outcomes (2)

• Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest

  The safety of MDMA-AT will be assessed by the number, type, and severity of adverse events.

  Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline).

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  The efficacy of MDMA-AT will be assessed using the CAPS-5 total severity score

  From baseline to 18-weeks post-baseline.

Secondary Outcomes (5)

• The PTSD Checklist for DSM-5 (PCL-5)

  From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

• The Inventory of Altered Self Capacities (IASC)

  From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

• Cognitive Flexibility Inventory (CFI)

  From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

• Self Compassion Scale Short Form (SCS-SF)

  From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

• Sheehan Disability Scale (SDS)

  From baseline to post-treatment (i.e., 18 weeks post-baseline), and again at two follow up timepoints (26- and 38-weeks post-baseline).

Other Outcomes (2)

• Changes in functional connectivity

  From baseline to 18-weeks post-baseline.

• Ecological Momentary Assessments (EMAs)

  Across 7 consecutive days leading up to and 10-days following each MDMA-AT session.

Study Arms (1)

Experimental: MDMA-AT for PTSD

EXPERIMENTAL

Open-label MDMA-assisted therapy (up to three sessions of 120mg MDMA)

Drug: MDMA assisted psychotherapy

Interventions

MDMA assisted psychotherapy DRUG

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

Experimental: MDMA-AT for PTSD

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Demographic and Participant Information
• Between the ages of 18-26 years old upon signing the written consent form
• Proficient in speaking and reading English.
• Capable of providing informed consent.
• Is able to swallow pills.
• Willing and able to be contacted by phone throughout the study
• Resides in the United States
• Meets DSM-5 criteria for PTSD with sufficient severity assessed at study screening
• History of index Criterion A trauma that occurred in childhood
• Must agree to inform the research team within 48 hours of any emerging or new medical conditions and/or procedures
• Must provide an emergency contact
• Has someone to drive them home after each MDMA-AT session (or agrees to take a taxi/rideshare while accompanied by a close other)
• Agree not to drive for 24 hours after each MDMA-AT session
• Agree to return to place of residence immediately after each MDMA-AT session, and stay there until the next morning
• Has a trusted close other who is at least 18 years of age that agrees to stay with them throughout the night until the morning after each MDMA-AT session, and is willing to attend the ICF meeting and co-sign the ICF

You may not qualify if:

• Recently attempted suicide or engaged in high risk self-injury or is otherwise assessed to be at imminent risk of suicide by study staff
• In the opinion of the PI, would present a serious risk to others as established through study screening measures or clinical observations.
• Meets DSM-5 criteria for any current substance use disorder, other than alcohol, cannabis, or nicotine use disorder
• For cannabis use and alcohol use disorders without physiological dependence, must agree to be abstinent from alcohol and cannabis for one week prior to and following each MDMA-AT session.
• Meets DSM-5 criteria for current cannabis or alcohol use disorder with physiological dependence, or physiological dependence cannot be determined
• Meets other DSM-5 criteria for serious mental illness, as assessed by the DART or through clinical interviews or observations
• Has a current restrictive eating disorder with current low body-mass index, or any eating disorder with active purging, currently, or in the 3 months prior to enrollment
• Diagnosed major neurodevelopmental or neurological disorder.
• Scaled score on the Test of Premorbid Functioning that is suggestive of possible cognitive impairment.
• Has used MDMA in the month prior to enrollment
• Has used MDMA excessively in the past
• Has participated in a previous MDMA-AT for PTSD clinical trial
• Has hypersensitivity to any ingredient of the Investigational Product
• Requires ongoing concomitant therapy with a psychiatric drug, excluding gabapentin.
• Is currently receiving trauma-focused psychotherapy and unwilling or unable to put treatment on hold for the duration of active study participation

Sponsors & Collaborators

• Jenna M. Traynor: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jenna M Traynor

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Velev, BA

CONTACT

617-855-3430; avelev@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)