Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

• Published in: Journal of psychopharmacology (Oxford) 2016-12, Vol.30 (12), p.1165-1180
• Main Authors: Ross, Stephen, Bossis, Anthony, Guss, Jeffrey, Agin-Liebes, Gabrielle, Malone, Tara, Cohen, Barry, Mennenga, Sarah E, Belser, Alexander, Kalliontzi, Krystallia, Babb, James, Su, Zhe, Corby, Patricia, Schmidt, Brian L
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anxiety; Anxiety - drug therapy; Cancer; Clinical significance; Cross-Over Studies; Depression - drug therapy; Double-Blind Method; Female; Hallucinogens - therapeutic use; Humans; Male; Mental depression; Middle Aged; Neoplasms - psychology; Original Papers; Patients; Psilocybin; Psilocybin - therapeutic use; Psychedelic drugs; Psychotherapy; Psychotherapy - methods; Quality of Life; Surveys and Questionnaires; Young Adult
• ISSN: 0269-8811; 1461-7285
• DOI: 10.1177/0269881116675512

Background: Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression. Methods: In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks. Results: Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60–80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression. Conclusions: In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress. Trial Registration: ClinicalTrials.gov Identifier: NCT00957359