state-funded trial assessing recovery and long-term impact of guided psilocybin for healing trauma

Conditions: PTSD

Summary: the principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of ptsd in us veterans.


Eligibility criteria:
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 period of 3 months. * concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 2 months prior to screening and is expected to remain stable during participation in the study. * be medically stable as determined by screening for medical problems via a personal interview, 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 frequent use of hallucinogens exclusion criteria: * general medical exclusion criteria: * individuals who are pregnant or nursing; individuals who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control * individuals with partners of childbearing potential who are sexually active and not 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), artificial heart valve, or tia in the past year • systolic blood pressure (sbp) \> 139 mm hg; 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 history of symptoms of hypoglycemia * psychiatric exclusion criteria: * current or past history of meeting dsm-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar i or ii disorder * current or history within six months of meeting dsm-5 criteria for a moderate or severe alcohol, tobacco, caffeine, or other drug use disorder; if a regular smoker, they must agree to use a nicotine patch on the day of dosing as smoking will not be allowed on these sessions * have a first degree relative with schizophrenia spectrum or other psychotic disorders including substance/medication-induced or due to another medical condition * risk for acute suicidality as determined by clinician judgment (c-ssrs) * has a psychiatric condition which precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, history of significant stress-related paranoia, and identity disturbances * history of a medically significant suicide attempt * current maoi antidepressant use

Keywords: ptsd veterans psilocybin trauma psychedelic