Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD

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.
• •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.
• •May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
• •May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the principal investigator or designated physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the principal investigator or designated physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.
• •May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the principal investigator or designated physician.
• •May have hypothyroidism if taking adequate and stable thyroid replacement medication.