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NCT Number: NCT07569159

MDMA Therapy in Veterans With PTSD

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sunstone Therapies

Rockville, Maryland, 20850, United States

Location status: Recruiting

Location contact

Manish Agarwal

PRINCIPAL_INVESTIGATOR

Michelle Leff

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MDMA

Drug

MDMA is a ring-substituted phenylisopropylamine derivative invented by the Merck pharmaceutical company in 1912.

Primary outcomes

  1. Safety and Tolerability

    Time frame: 15 months

    To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.

  2. C-SSRS

    Time frame: 15 months

    Incidence of changes in suicidal ideation/behavior (measured using the Columbia-Suicide Severity Rating Scale [C-SSRS]) score at all visits from Baseline to EOS Visit.

Secondary outcomes

  1. Efficacy of Therapy

    Time frame: 15 months

    To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Clinician Administered PTSD Scale. (CAPS-5)

  2. Effect of Therapy

    Time frame: 15 months

    To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Sheehan Disability Scale. (SDS)

  3. Efficacy of Therapy

    Time frame: 15 months

    To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the PTSD Checklist for DSM-5.(PCL-5)

  4. Efficacy of Therapy

    Time frame: 15 months

    To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the State-Trait Anxiety Inventory. (STAI)

  5. Efficacy of Therapy

    Time frame: 15 months

    To assess the efficacy of individual vs. group MDMA-assisted therapy on symptoms of PTSD in adult participants using the change from Baseline to EOS Visit in the Quick Inventory of Depressive Symptomatology- Self-Report. ( QIDS-SR-16)

  6. Effect of Therapy

    Time frame: 15 months

    To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the EQ-5D-5L.

  7. Effects of Therapy

    Time frame: 15 months

    To assess the effect of individual vs. group MDMA-assisted therapy on quality of life and participant functional impairment in adult participants with PTSD using the change from baseline to EOS using the Clinician Administered PTSD Scale. (CAPS-5)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Evaluation Team

CONTACT

[email protected]

(301) 750-3401

Kalisha Watkins

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sunstone Medical

Other

Registry information

Official study title

A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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