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

Stephen Ross, Anthony P. Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara C. Malone, Barry H. Cohen, Sarah E. Mennenga, Alexander Belser, Krystallia Kalliontzi, James Babb, Zhe Su, Patricia Corby, Brian L Schmidt

Journal of Psychopharmacology November 30, 2016 DOI: 10.1177/0269881116675512 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Double-blind, placebo-controlled, crossover trial Randomized Peer reviewed
Sample size 29
Population Patients with cancer-related anxiety and depression
Interventions Psilocybin Niacin
Dose 0.3 mg/kg
Duration 7-week primary outcome assessment, 6.5-month follow-up
Topics Anxiety Depression Mystical experience Psilocybin
Keywords Cancer Psychedelic therapy psilocybin Treatment Psychotherapy Psychedelic compound Emotional burden Quality of life Psilocybin-induced mystical experience
Citations 1,699
Registration NCT00957359
Key findings Single-dose psilocybin (0.3 mg/kg) plus psychotherapy produced rapid, robust, and enduring reductions in anxiety and depression in patients with cancer-related psychological distress.

Abstract

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

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