The primary objective of this double-blind, placebo-controlled pilot crossover study (n=29) is to assess the efficacy of a single oral psilocybin dose (0.3 mg/kg) versus niacin (250 mg) on anxiety associated with cancer, with follow-up to 6 months.
Randomized, double-blind, quadruple-masked crossover trial comparing a single oral dose of psilocybin (0.3 mg/kg) with active niacin control (250 mg) in patients with current or historical cancer-related anxiety; crossover interval ~7 weeks with follow-up assessments to 6 months.
Outcomes include anxiety related to cancer as the primary measure, and secondary measures of pain perception, depression, existential/psychospiritual distress, attitudes toward disease and death, quality of life, and mystical/spiritual states. Study conducted under IND with IRB and DEA approvals.
Psilocybin 0.3 mg/kg oral single dose; crossover design with niacin.
Single dose; crossover at 7 weeks; follow-up to 6 months.
Active niacin control (250 mg) in identical capsule.
Niacin 250 mg active comparator; identical opaque capsule.