Actively Recruiting
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
Led by Sunstone Medical · Updated on 2026-05-04
35
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cisgender women who are at least 18 years old.
- Meet DSM-5 criteria for current PTSD secondary to sexual assault occurring 6 or more months ago.
- CAPS-5 score of 25 or higher at baseline.
- Able to swallow pills.
- Willing to have a family member, caregiver, or trusted person drive them home after the dosing session.
- Able to complete all required assessments without assistance.
- If able to become pregnant, must have a negative pregnancy test at study entry and before dosing, and agree to use effective birth control through 10 days after dosing if sexually active with a male partner.
- Agree to inform investigators within 48 hours of any medical conditions or procedures.
- Proficient in speaking and reading English.
- Agree to have all clinic visits recorded (may opt out of recording analysis).
- Agree to lifestyle modifications including light breakfast 2-3 hours before dosing, no caffeine or nicotine 2 hours before and 6 hours after dosing, no alcohol 24 hours before dosing, no enrollment in other interventional studies during this study, transportation arranged after dosing, and commitment to study procedures.
- Agree to refrain from starting new medications or psychotherapy treatments during the study.
- May continue stable SSRI treatment if on a stable dose for 3 months or longer before enrollment.
- Must be tapered off MAOIs before dosing.
- May remain in stable psychotherapy for more than 3 months.
- May have well-controlled hypertension treated with medication.
- May have asymptomatic hepatitis C virus if evaluated and treated as needed.
- May have alcohol or substance use disorder if not in withdrawal or detox, with an approved plan to reduce use.
- May have stable type 2 diabetes with additional screening and investigator approval.
- May have hypothyroidism if on stable thyroid replacement medication.
You will not qualify if you...
- Male gender.
- Conditions impairing oral intake or digestive absorption.
- Unable to provide adequate informed consent.
- Significant suicide risk with intent and plan in past 3 months.
- Any current problem interfering with participation as judged by investigator.
- Risk to others established by clinical interview or therapist.
- History or current diagnosis of schizophrenia, schizoaffective disorder, psychotic disorders, major depressive disorder with psychotic features, bipolar type 1, or personality disorders.
- Require ongoing psychiatric medication except as allowed.
- Received electroconvulsive therapy within 12 weeks of enrollment.
- Recent stroke (<6 months), recent myocardial infarction (<6 months), or significant arrhythmia within 1 year.
- Significant hematological, endocrine, cerebrovascular, cardiovascular, pulmonary, renal, gastrointestinal, immunocompromised, neurological disorders, or seizure disorder increasing risk.
- Uncontrolled hypertension (≥140/90 mmHg).
- Abnormal vital signs, ECG, or lab results at screening or baseline.
- Symptomatic liver disease.
- Pregnant, nursing, or able to become pregnant without effective birth control if sexually active with male partner.
- Hypersensitivity to any study drug ingredient.
- Positive urine drug screen for illicit drugs prior to dosing session.
- Current participation in another investigational drug or device study or within 30 days.
- Personal circumstances incompatible with safe study participation (e.g., active legal proceedings).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sunstone Medical, PC
Rockville, Maryland, United States, 20850
Actively Recruiting
Research Team
C
Clinical Evaluation Team
CONTACT
C
Celia Leeks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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