MDMA Therapy in Veterans With PTSD

Part of paid clinical trials in Rockville, Maryland.

Sponsor
Sunstone Medical
Study ID
NCT07569159
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Individual
  • Experimental: Group

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sunstone TherapiesRockvilleMaryland20850
Manish Agarwal (PRINCIPAL_INVESTIGATOR)
Michelle Leff (SUB_INVESTIGATOR)

Find similar trials in Rockville, MD

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Sunstone Therapies· Rockville, MD

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