Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma

Randomised, quadruple-blind, parallel-group pilot trial comparing two oral doses of psilocybin (25 mg versus 4 mg) delivered in two day-long psychotherapy sessions scheduled 7–14 days apart in adults with stage IV melanoma and new-onset anxiety.

Primary outcomes include measures of anxiety, depression, quality of life and spirituality; immune outcome: natural killer cell counts from blood samples taken the day after psilocybin sessions; safety assessed with labs and adverse event monitoring.

Procedures include two preparatory psychotherapy sessions, overnight stay after dosing, psychotherapy follow-up the day after each session and additional follow-up two weeks after the second session; subjects receiving low-dose active placebo may be offered an open-label phase.