Clinical TrialParallelPTSDMDMAMDMANot yet recruiting

MDMA Therapy in Veterans With PTSD

This Phase II, randomised, open-label trial (n=52) will study the safety, tolerability and efficacy of MDMA-assisted therapy in adult veterans with post-traumatic stress disorder (PTSD). Participants will receive oral MDMA as part of therapy in either individual or group settings. The study is a single-centre, fixed-dose, parallel-group design with two experimental arms: individual therapy and group therapy. The MDMA regimen is 120 mg orally followed by a supplemental 60 mg dose, and the main outcomes are safety, tolerability and the Columbia Suicide Severity Rating Scale (C-SSRS) assessed over 15 months.

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Target Enrollment
52 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

unknown

Study Arms & Interventions

Individual

experimental

Interventions

  • MDMA120 - 60 mg
    via Oral• 120 mg dose followed by a supplemental 60 mg dose• 2 doses total

Group

experimental

Interventions

  • MDMA120 - 60 mg
    via Oral• 120 mg dose followed by a supplemental 60 mg dose• 2 doses total

Participants

Ages
18 – ?
Sexes
Male & Female

Inclusion Criteria

  • Veterans who are at least 18 years old
  • Are able to swallow pills
  • Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
  • Proficient in speaking and reading English.

Exclusion Criteria

  • Condition impairing oral intake or digestive absorption.
  • Unable to give adequate informed consent.
  • Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months
  • Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)
  • A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
  • Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.
  • Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment52 participants
  • Timeline
    Start: 2026-05-01
    End: 2027-08-01
  • Compounds
    MDMAMDMA
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Investigators

  • MA
    Manish Agrawal

Locations

Sunstone Therapies — Rockville, Maryland, United States