This Phase II, open-label trial (n=35) will study the efficacy, safety, and tolerability of psilocybin (25mg) combined with therapy in women with post-traumatic stress disorder (PTSD) stemming from sexual assault.
Sponsored by Sunstone Medical/Therapeutics, this single-centre trial will investigate whether a fixed oral dose of psilocybin administered alongside psychotherapy can alleviate symptoms of PTSD in women whose trauma is specifically linked to sexual assault. The study includes preparatory therapy, one psilocybin dosing session, and follow-up integration sessions. Participants will be closely monitored for adverse events and changes in suicidal ideation using standard psychiatric tools, such as the Columbia-Suicide Severity Rating Scale (C-SSRS). Eligibility is restricted to cisgender women aged 18 and above who meet PTSD diagnostic criteria with an index trauma of sexual assault occurring at least six months prior to enrolment.
The primary focus is on determining the treatment’s safety and tolerability over the course of approximately eight weeks. This includes recording any treatment-emergent adverse events, shifts in suicidal ideation or behaviour, and participants’ overall ability to tolerate the intervention. The trial also supports broader efforts to explore psilocybin-assisted therapy as a trauma-informed approach for PTSD populations underserved by current treatments.
Trial Details
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.Trial Number NCT06902974
Sponsors & Collaborators
Sunstone TherapiesSunstone Therapies is dedicated to the development and implementation of innovative therapies for individuals affected by cancer and other conditions.