Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

Part of paid clinical trials in Rockville, Maryland.

Sponsor
Sunstone Medical
Study ID
NCT06902974
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Psilocybin 25 mg — DRUG
    Single dose, 25mg psilocybin, encapsulated, oral administration

Study Details

A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin-Assisted Therapy
    This is a Phase 2, single-center, fixed dose, open-label study to explore the efficacy, safety, and tolerability of a 25 mg dose of oral psilocybin with therapy in adult women participants with PTSD secondary to an index trauma of sexual assault. There is no comparator group.

Primary Outcome Measure

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault [ Time Frame: Between ICF until End of Study (approx. 8 weeks from baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sunstone Medical, PCRockvilleMaryland20850
Clinical Evaluation Team
[email protected]
301-750-3401
Celia Leeks
[email protected]
Manish Agrawal, MD, MSc (PRINCIPAL_INVESTIGATOR)
Michelle Leff, MD (SUB_INVESTIGATOR)

Find similar trials in Rockville, MD

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

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