Recruiting
Phase 2

MDMA

Sponsor:

Sunstone Medical

Code:

NCT07569159

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MDMA

Study Details

Brief summary:

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT07569159

Start date

Jun 30, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Individual

experimental: Group

Interventions

MDMA

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

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 15 months ]
  • C-SSRS [ Time Frame: 15 months ]

Central Contacts and Locations

Central contacts

Clinical Evaluation Team

(301) 750-3401clinical.specialists@sunstonetherapies.com

Kalisha Watkins

kalisha.watkins@sunstonetherapies.com

Locations

Sunstone Therapies

Recruiting

Rockville, Maryland, United States, 20850

Principal Investigator:

Manish Agarwal

More Information

Sponsor

Sunstone Medical

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunstone Medical on 2026-07-01.