Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

NCT06902974 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD; Post Traumatic Stress Disorder

Keywords

PTSD; sexual assault; psilocybin; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (2)

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

  Incidence and occurrence of treatment emergent adverse events (TEAEs) and SAEs from signing of Informed Consent Form (ICF) until the End of Study (EOS) Visit

  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

  Incidence of changes in suicidal ideation/behavior (measured using the C-SSRS) score at all visits from Baseline to End of Study Visit

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

Secondary Outcomes (9)

• To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

  From Baseline to End of Study (approx. 8 weeks from baseline)

• To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

  From Baseline to End of Study (approx. 8 weeks from baseline)

• To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

  From Baseline to End of Study (approx. 8 weeks from baseline)

• To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

  From Baseline to End of Study (approx. 8 weeks from baseline)

• To assess the efficacy of psilocybin-assisted therapy on symptoms of PTSD in adult participants with PTSD secondary to sexual assault

  From Baseline to End of Study (approx. 8 weeks from baseline)

Study Arms (1)

Psilocybin-Assisted Therapy

EXPERIMENTAL

This is a Phase 2, single-center, fixed dose, open-label study to explore the efficacy, safety, and tolerability of a 25 mg dose of oral psilocybin with therapy in adult cisgender women participants with PTSD secondary to an index trauma of sexual assault. There is no comparator group.

Drug: Psilocybin 25 mg

Interventions

Psilocybin 25 mg DRUG

Single dose, 25mg psilocybin, encapsulated, oral administration

Also known as: Psilocybin-assisted therapy

Psilocybin-Assisted Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender femal
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Agree to the following lifestyle modifications: a light breakfast 2 to 3 hours before dosing is permitted, however, participants will refrain from caffeine and nicotine 2 hours prior to dosing sessions and at least 6 hours after dosing, abstain from alcohol for 24 hours prior to dosing, not enroll in any other interventional clinical studies during the duration of the study, be driven home after the Dosing Session, and commit to medication dosing, therapy, and study procedures.
• Agree to refrain from beginning new medication and/or psychotherapy treatment.
• Continued treatment with SSRIs will be permitted if participants have been on a stable dose for 3 months or longer prior to enrollment. However, participants must be tapered off of monoamine oxidase inhibitors (MAOIs) prior to dosing.
• In addition, participants may remain in stable (\> 3 months) psychotherapy.
• May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines.

You may not qualify if:

• 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.
• Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration.
• Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury \[mmHg\] or higher).
• Abnormal and clinically significant results on vital signs, ECG, or laboratory tests at screening and baseline
• Have symptomatic liver disease.
• Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.

Sponsors & Collaborators

• Sunstone Medical: lead

Study Sites (1)

Sunstone Medical, PC

Rockville, Maryland, 20850, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Manish Agrawal, MD, MSC

  Sunstone Medical, PC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Evaluation Team

CONTACT

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

Celia Leeks

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase 2, single-center, fixed dose, open-label study to explore the efficacy, safety, and tolerability of a 25 mg dose of oral psilocybin with therapy in adult cisgender women participants with PTSD secondary to an index trauma of sexual assault.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)