A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)
Sunstone Medical
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Cisgender women who are at least 18 years old. * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index trauma is sexual assault that occurred 6 or more months in the past). * CAPS-5 score of 25 or higher at Baseline. * Are able to swallow pills. * Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation. * Are able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted…
Interventions
- DrugPsilocybin 25 mg
Single dose, 25mg psilocybin, encapsulated, oral administration
Location
- Sunstone Medical, PCRockville, Maryland