NCT07569159

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
15mo left

Started May 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2027

First Submitted

Initial submission to the registry

November 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

November 10, 2025

Last Update Submit

May 5, 2026

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability

    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.

    15 months

  • C-SSRS

    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.

    15 months

Secondary Outcomes (7)

  • Efficacy of Therapy

    15 months

  • Effect of Therapy

    15 months

  • Efficacy of Therapy

    15 months

  • Efficacy of Therapy

    15 months

  • Efficacy of Therapy

    15 months

  • +2 more secondary outcomes

Study Arms (2)

Individual

EXPERIMENTAL
Drug: MDMA

Group

EXPERIMENTAL
Drug: MDMA

Interventions

MDMADRUG

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

GroupIndividual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunstone Therapies

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Manish Agarwal

    Sunstone Medical, PC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Evaluation Team

CONTACT

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

Candace Parks

CONTACT

(301) 750-3401candace.parks@sunstonetherapies.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2025

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)