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Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer

Gurpreet S Chopra, Marycie Hagerty, Charles S. Grob, Alicia Danforth, Charles R. Mckay, Adam L. Halberstadt, George Greer

Archives of General Psychiatry September 7, 2010 DOI: 10.1001/archgenpsychiatry.2010.116 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Double-blind, placebo-controlled study Pilot study Peer reviewed
Sample size 12
Population Adults with advanced-stage cancer and anxiety
Intervention Psilocybin
Dose 0.2 mg/kg
Duration 6-month follow-up after treatment
Topics Anxiety Psilocybin
Keywords Mood Clinical psychology Beck depression inventory Beck anxiety inventory Adverse effect
Citations 1,220
Registration NCT00302744
Key points Psilocybin was safe and associated with reduced anxiety and improved mood in patients with advanced-stage cancer and reactive anxiety.

Abstract

CONTEXT: Researchers conducted extensive investigations of hallucinogens in the 1950s and 1960s. By the early 1970s, however, political and cultural pressures forced the cessation of all projects. This investigation reexamines a potentially promising clinical application of hallucinogens in the treatment of anxiety reactive to advanced-stage cancer.

Objective: To explore the safety and efficacy of psilocybin in patients with advanced-stage cancer and reactive anxiety.

Design: A double-blind, placebo-controlled study of patients with advanced-stage cancer and anxiety, with subjects acting as their own control, using a moderate dose (0.2 mg/kg) of psilocybin.

Setting: A clinical research unit within a large public sector academic medical center.

Participants: Twelve adults with advanced-stage cancer and anxiety. MAIN OUTCOME MEASURES: In addition to monitoring safety and subjective experience before and during experimental treatment sessions, follow-up data including results from the Beck Depression Inventory, Profile of Mood States, and State-Trait Anxiety Inventory were collected unblinded for 6 months after treatment.

Results: Safe physiological and psychological responses were documented during treatment sessions. There were no clinically significant adverse events with psilocybin. The State-Trait Anxiety Inventory trait anxiety subscale demonstrated a significant reduction in anxiety at 1 and 3 months after treatment. The Beck Depression Inventory revealed an improvement of mood that reached significance at 6 months; the Profile of Mood States identified mood improvement after treatment with psilocybin that approached but did not reach significance.

Conclusions: This study established the feasibility and safety of administering moderate doses of psilocybin to patients with advanced-stage cancer and anxiety. Some of the data revealed a positive trend toward improved mood and anxiety. These results support the need for more research in this long-neglected field.

Trial Registration: clinicaltrials.gov Identifier: NCT00302744.

In the evidence

This study is part of the evidence base for 3 syntheses in the library. Here is how each one recorded it.

  • Psilocybin (0.2 mg/kg) was safe and associated with significant reduction in trait anxiety at 1 and 3 months and improved mood.

    Synthesized

  • Psilocybin was safe and associated with significant reductions in trait anxiety at 1 and 3 months after treatment.

    Synthesized

  • Psilocybin was safe and associated with reduced anxiety and improved mood, with significant trait anxiety reduction at 1 and 3 months.

    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
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
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
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

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