Trials / Not Yet Recruiting
Not Yet RecruitingNCT06902974
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Sunstone Medical · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The proposed Phase 2, single-center, fixed dose, open-label study will explore the efficacy, safety, and tolerability of 25 mg dose of oral psilocybin in conjunction with therapy in cisgender women participants diagnosed with PTSD secondary to an index trauma of sexual assault.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Psilocybin 25 mg | Single dose, 25mg psilocybin, encapsulated, oral administration |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-11-01
- Completion
- 2027-10-01
- First posted
- 2025-03-30
- Last updated
- 2025-11-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06902974. Inclusion in this directory is not an endorsement.