Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSunstone Medical
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Male
Condition impairing oral intake or digestive absorption.
Are not able to give adequate informed consent.
Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months
Trial design
Treatments tested in this trial
- Psilocybin 25 mg
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov