The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma
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.
• 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