Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06989957
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Psilocybin — DRUG
    Experimental Psilocybin (exact dosages not disclosed)
  • Psilocybin — DRUG
    Comparator Psilocybin (exact dosages not disclosed)
  • MDMA — DRUG
    Experimental MDMA (exact dosages not disclosed)
  • MDMA — DRUG
    Comparator MDMA (exact dosages not disclosed)

Study Details

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet

Key Dates

Start date
Sep 17, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: Experimental MDMA + psilocybin (exact dosage not disclosed)
    MDMA will be given initially, followed by psilocybin 30 minutes later.
  • Active Comparator: Comparator MDMA + psilocybin (exact dosage not disclosed)
    MDMA will be given initially, followed by psilocybin 30 minutes later.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: 30 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Chloe Ford, MSc
410-550-0237
Brandon Weiss, PhD (PRINCIPAL_INVESTIGATOR)

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