Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed with Advanced Stage Cancer
This open-label, Phase I trial (n=15) will assess the safety and efficacy of psilocybin (25mg) alongside psychotherapy for treating demoralization syndrome in patients with advanced-stage cancer.
Details
Open-label single-group pilot enrolling 15 participants with advanced cancer and demoralization to evaluate safety and change in demoralization after one 25 mg psilocybin dosing session with CALM-informed preparation and integration therapy.
The intervention includes four preparation sessions, an approximately 8-hour supervised oral dosing session, a next-day integration session and a second integration two weeks later; partial responders may be offered a second identical dosing period.
Outcomes include change on the Demoralization Scale, adverse events, HDRS, HARS and the Columbia Suicide Severity Rating Scale.