MDMA-AT for PTSD in Young Adults With Childhood Trauma

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Jenna M. Traynor
Study ID
NCT07765693
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • MDMA assisted psychotherapy — DRUG
    Recruiting young adults with PTSD for an interventional study testing a combination of MDMA and talk therapy.

Study Details

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

Key Dates

First listed
Aug 14, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Jan 30, 2028
Completion
Dec 1, 2028

Study Design

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

Arms

  • Experimental: Experimental: MDMA-AT for PTSD
    Open-label MDMA-assisted therapy (up to three sessions of 120mg MDMA)

Primary Outcome Measure

Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest [ Time Frame: Assessed from baseline to 18-weeks post baseline, and again at two follow-up timepoints (26- and 38-weeks post-baseline). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Alexandra Velev, BA
[email protected]
617-855-3430

Find similar trials in Belmont, MA

By research site
McLean Hospital· Belmont, MA

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