State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

Inclusion Criteria:

• Be a United States Military Veteran

• Have at least a high-school level of education or equivalent (e.g. GED).

• Have a current DSM-5 diagnosis of Post-traumatic Stress Disorder

• Have a CAPS-5 total severity score of ≥23 at baseline

• SSRIs will be allowable so long as participants are on a stable regimen for a periodof 3 months.

• Concurrent psychotherapy is allowed if the type and frequency of the therapy hasbeen stable for at least 2 months prior to screening and is expected to remainstable during participation in the study.

• Be medically stable as determined by screening for medical problems via a personalinterview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests

• No use of hallucinogens in the past 3 months and no history of regular or frequentuse of hallucinogens

Exclusion Criteria:

• General medical exclusion criteria:

• Individuals who are pregnant or nursing; individuals who are of child-bearingpotential and sexually active who are not practicing a highly effective meansof birth control

• Individuals with partners of childbearing potential who are sexually active andnot practicing a highly effective means of contraception

• Cardiovascular conditions: coronary artery disease, stroke, angina,uncontrolled hypertension, a clinically significant ECG abnormality (e.g.,atrial fibrilation), prolonged QTc interval (i.e., QTc > 450 msec), artificialheart valve, or TIA in the past year • Systolic blood pressure (SBP) > 139 mmHG; diastolic blood pressure (DBP) > 89 mm HG; heart rate (HR) > 90 bpm.

• Epilepsy with history of seizures

• Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no historyof symptoms of hypoglycemia

• Psychiatric Exclusion Criteria:

• Current or past history of meeting DSM-5 criteria for schizophrenia spectrum orother psychotic disorders (except substance/medication-induced or due toanother medical condition), or Bipolar I or II Disorder

• Current or history within six months of meeting DSM-5 criteria for a moderateor severe alcohol, tobacco, caffeine, or other drug use disorder; if a regularsmoker, they must agree to use a nicotine patch on the day of dosing as smokingwill not be allowed on these sessions

• Have a first degree relative with schizophrenia spectrum or other psychoticdisorders including substance/medication-induced or due to another medicalcondition

• Risk for acute suicidality as determined by clinician judgment (C-SSRS)

• Has a psychiatric condition which precludes the establishment of therapeuticrapport as evidenced by long-term patterns of unstable relationships, historyof significant stress-related paranoia, and identity disturbances

• History of a medically significant suicide attempt

• Current MAOI antidepressant use