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

Detailed criteria

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

Drug
Psilocybin 25 mg
Single dose, 25mg psilocybin, encapsulated, oral administration

Location

Sunstone Medical, PC
Rockville, Maryland
clinical.specialists@sunstonetherapies.com 301-750-3401

A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)

Summary

Eligibility

Interventions

Location

Compensation

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Details

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