This double-blind cross-over trial (n=12) investigates the effects of psilocybin (14 mg/70 kg; 0.2 mg/kg) versus active niacin placebo on anxiety in advanced-stage cancer patients.
A randomised, double-blind, within-subject crossover pilot (n=12) tests single oral psilocybin sessions (0.2 mg/kg) versus an active niacin placebo in people with advanced cancer and clinically significant anxiety.
Each participant undergoes two overnight admissions three to six weeks apart; sessions are approximately six hours. MRI is performed prior to admission to exclude CNS involvement.
Outcomes include measures of anxiety, depression and physical pain; at least two preparatory psychotherapy meetings are provided before dosing, with safety screening including labs, ECG and pregnancy testing where applicable.
Single 6-hour psilocybin session (0.2 mg/kg).
Capsule; 6-hour monitored session.
Single 6-hour active-niacin placebo session.
Niacin active placebo capsule.