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
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).
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