Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer
Phase I/II single-group trial (n=55 actual) of oral psilocybin plus group and individual therapy for anxiety and/or depression in patients with metastatic cancer to assess safety and side effects.
Details
This Phase I/II single-group treatment study evaluates pharmaceutical-grade oral psilocybin administered alongside group and individual psychotherapy for patients with metastatic cancer experiencing clinically significant anxiety and/or depressive symptoms.
Primary outcomes focus on safety and adverse events; secondary assessments include anxiety and depression measures. Eligible participants must be medically stable, off contraindicated psychotropic medications, and able to participate in group therapy.
Psilocybin used is a pharmaceutical-grade formulation (CY-39/Indocybin) given orally with preparatory and integration sessions.