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Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

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

NCT06902974•Sunstone Medical

View on ClinicalTrials.gov

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

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 assessments, and to comply with all study visits.
•If able to become pregnant (i.e., with uterus and associated reproductive organs, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to the Dosing Session, and must agree to use adequate birth control through 10 days after the Dosing Session if sexually active with a biologically male partner. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
•Must agree to inform the clinical investigators within 48 hours of any medical conditions and procedures.
•Are proficient in speaking and reading English.
•Agree to have all clinic visit sessions recorded to audio and/or video. Participants may opt out of the data analysis of the recordings.
+9 more criteria

Exclusion Criteria

•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
•Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.
•Would present a serious risk to others as established through clinical interview and contact with treating therapist.
•Have a history of, or a current primary, schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.
•Require ongoing concomitant therapy with a psychiatric medication with exceptions described below (see Section 6.6).
•Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
•Have evidence or history of recent stroke (\< 6 months from signing of ICF), recent myocardial infarction (\< 6 months from signing of ICF), or clinically significant arrhythmia within 1 year of signing the ICF.
+9 more criteria

Locations (1)

Sunstone Medical, PC

Rockville, Maryland, United States

Key Dates

Start Date

December 1, 2025

Primary Completion Date

November 1, 2026

Completion Date

October 1, 2027

Last Updated

November 25, 2025

Enrollment

ESTIMATED participants

Conditions

Post Traumatic Stress DisorderPTSD

Interventions

Psilocybin 25 mg

DRUG

Contacts

Clinical Evaluation Team

CONTACT

301-750-3401 clinical.specialists@sunstonetherapies.com

Celia Leeks

CONTACT

301-750-3229 celia.leeks@sunstonetherapies.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

Inclusion Criteria

Exclusion Criteria

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