RecruitingPhase 2

Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

United States70 participantsStarted 2026-04

Plain-language 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).

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 spe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Timeframe: Between ICF until End of Study (approx. 8 weeks from baseline)

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Timeframe: Between Baseline to End of Study (approx. 8 weeks from baseline)

Trial details

NCT IDNCT06902974

SponsorSunstone Medical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Clinical Evaluation Team

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

View on ClinicalTrials.gov More Post Traumatic Stress Disorder trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Timeframe: Between ICF until End of Study (approx. 8 weeks from baseline)

To assess the safety and tolerability of psilocybin-assisted therapy in adult participants with PTSD secondary to sexual assault

Timeframe: Between Baseline to End of Study (approx. 8 weeks from baseline)