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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)

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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

In the evidence

This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.

  • State of the evidence: Psilocybin for anxiety Supports

    Single-dose psilocybin plus psychotherapy produced immediate, substantial anxiety and depression improvements, with roughly 60-80% retaining clinically significant reductions at 6.5 months.

    Synthesized

  • State of the evidence: Anxiety Supports

    Single-dose psilocybin plus psychotherapy produced rapid, substantial, and sustained improvements in anxiety and depression, with 60-80% of participants showing clinically significant reductions at 6.5-month follow-up.

    Synthesized

  • State of the evidence: Depression Supports

    Single-dose psilocybin with psychotherapy produced immediate and sustained reductions in depression and anxiety, with roughly 60-80% showing clinically significant reductions at 6.5 months.

    Synthesized

  • State of the evidence: Mystical experience Supports

    Single-dose psilocybin plus psychotherapy produced rapid and enduring reductions in anxiety and depression, and the psilocybin-induced mystical experience mediated the therapeutic effect.

    Synthesized

Comparable studies

Other randomized controlled trials on psilocybin for anxiety, most cited first.

Study Year Design Participants
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12
Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies Healthy human subjects 2010 Pooled analysis of double-blind placebo-controlled experimental studies n = 110
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up Patients aged 21–75 with moderate to severe unipolar depression 2022 Randomized waiting-list controlled study n = 27

Citations in the library

Cited by 1,355

and 1,350 more in the library

Cites 29

and 24 more in the library

Related reading

Explore topics

Anxiety Depression Mystical experience Psilocybin End-of-life distress Mysticism

By condition and practice

Psilocybin for anxiety Psilocybin for depression