Psilocybin-Assisted Randomized Therapy

Inclusion Criteria

• •Eligible participants must be over the age of 18. They must self-identify as Georgia military veterans, reservists, National Guard members, or active-duty service members. Additionally, they must be seeking treatment for PTSD, which will be confirmed by a CAPS-5-R assessment. The criteria below will be applicable to all participants, regardless of study treatment arm.
• •1. Meet criteria for PTSD due to trauma occurring at least 6 months prior based on CAPS-5-R diagnostic scoring rules.
• •2. Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
• •3. Are 18 years and older.
• •4. Are able to visually read and understand the English language and give written informed consent.
• •5. Are able to swallow pills.
• •6. Agree to have study visits video and/or audio recorded, including dosing session, Independent Rater assessments, and non-drug psychotherapy sessions.
• •7. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• •8. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
• •9. If able to become pregnant, must have a negative pregnancy test prior to study entry, at study entry, and prior to the psilocybin Session. They must agree to use highly effective birth control for a month prior to the psilocybin session and through 10 days after the Medicine session. Highly effective birth control methods include intrauterine device, 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). Not able to become pregnant is defined as permanent sterilization, postmenopausal (i.e., 12 consecutive months without menstruation), or assigned male at birth.
• •10. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to the psilocybin Session, not participate in any other interventional clinical trials during the duration of the treatment, and be accompanied to hotel after Medicine Session, and commit to medication dosing, therapy, and study procedures.