Clinical TrialPTSDPsilocybinNot yet recruiting

Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD (SUN004)

Phase II, single-group, open-label study (n=35) of a single 25 mg oral psilocybin dose with psychotherapy for cisgender women with PTSD secondary to sexual assault.

Target Enrollment
35 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This Phase 2, single-center, fixed-dose, open-label study evaluates a single 25 mg oral psilocybin dose administered with preparatory and integration psychotherapy in cisgender women with PTSD following sexual assault (n=35).

Primary aims are efficacy, safety, and tolerability; key entry criteria include CAPS-5 ≥25, stable SSRI use permitted, negative pregnancy test and contraception requirements, and exclusion for significant suicidal risk or psychotic/bipolar disorders.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin-assisted therapy

experimental

Fixed single 25 mg oral psilocybin administered with preparatory and integration psychotherapy; single-group open-label.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Encapsulated oral administration paired with psychotherapy.

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • 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, 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 (two forms of contraception required with barrier methods).
  • 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 (may opt out of data analysis of recordings).
  • Agree to lifestyle modifications (light breakfast allowed 2–3 hours before dosing; refrain from caffeine and nicotine 2 hours prior and at least 6 hours after dosing; abstain from alcohol 24 hours prior; not enroll in other interventional clinical studies during study; be driven home after dosing; commit to medication dosing, therapy, and study procedures).
  • Agree to refrain from beginning new medication and/or psychotherapy treatment.
  • Continued treatment with SSRIs permitted if on a stable dose for 3 months or longer prior to enrollment; MAOIs must be tapered off prior to dosing.
  • May remain in stable (>3 months) psychotherapy.
  • May have well-controlled hypertension treated with antihypertensives.
  • May have asymptomatic Hepatitis C previously evaluated/treated as needed.
  • May have alcohol or substance use disorder if not in withdrawal or requiring detox and with an agreed plan to reduce use.
  • May have Type 2 Diabetes if stable and cardiovascular risk ruled out.
  • May have hypothyroidism if stable on replacement medication.

Exclusion Criteria

  • Exclusion Criteria:
  • Male.
  • Condition impairing oral intake or digestive absorption.
  • Unable to give adequate informed consent.
  • Significant suicide risk as defined by suicidal ideation with intent and a plan as endorsed on item 5 on the C-SSRS within the past 3 months.
  • 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.
  • History of, or 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 in protocol.
  • Received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
  • Evidence or history of recent stroke (<6 months), recent myocardial infarction (<6 months), or clinically significant arrhythmia within 1 year.
  • Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged to significantly increase the risk of psilocybin administration.
  • Uncontrolled hypertension (>=140/90 mmHg).
  • Abnormal and clinically significant vital signs, ECG, or laboratory tests at screening/baseline.
  • Symptomatic liver disease.
  • Pregnant, nursing, or able to become pregnant and not practicing effective birth control if sexually active with a biologically male partner.
  • Hypersensitivity to any ingredient of the study drug.
  • Positive urine drug screen for illicit drugs or drugs of abuse prior to the Dosing Session (reviewed at investigator discretion).
  • Current enrollment in any investigational drug or device study or participation within 30 days of screening.
  • Other personal circumstances/behavior judged incompatible with safe exposure to psilocybin or completion of study procedures (e.g., active legal proceedings).

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment35 participants
  • Timeline
    Start: 2025-08-01
    End: 2027-10-01
  • Compound
    Psilocybin
  • Topic
    PTSD

Locations

Sunstone Medical, PC — Rockville, Maryland, United States

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