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
In the evidence
This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.
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Single-dose psilocybin (0.3 mg/kg) plus psychotherapy produced immediate and sustained reductions in anxiety and depression, with roughly 60-80% showing clinically significant reductions at 6.5 months.
Synthesized
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Single-dose psilocybin (0.3 mg/kg) plus psychotherapy produced rapid, substantial, and enduring reductions in anxiety and depression, with approximately 60-80% of participants continuing to show clinically significant reductions at 6.5 months.
Synthesized
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State of the evidence: Anxiety Supports
Single-dose psilocybin plus psychotherapy produced rapid, substantial, and enduring reductions in anxiety and depression, with 60-80% of participants maintaining clinically significant improvements at 6.5 months.
Synthesized
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State of the evidence: Depression Supports
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.
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 |