Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer
This is the first (modern) double-blind placebo-controlled study (n=12) of psilocybin (14mg/70kg) for the treatment of (end-of-life) anxiety (and depression) related to cancer. Treatment led to a significant reduction in anxiety symptoms up to three months after treatment and improvements in depressive symptoms reached significance after six months.
Authors
- Charles Grob
- Adam Halberstadt
- Alicia Danforth
Published
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.
Research Summary of 'Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer'
Introduction
Interest in addressing the psychological, spiritual and existential distress experienced by patients with advanced-stage cancer has re-emerged after a long hiatus in clinical research. Earlier trials from the 1950s to early 1970s reported that hallucinogens could produce psychospiritual experiences associated with sustained improvements in mood and reduced anxiety in terminally ill patients, but research largely ceased for political and cultural reasons. Psilocybin, a naturally occurring psychedelic metabolised to psilocin and acting as an agonist at serotonin 5-HT1A/2A/2C receptors (with 5-HT2A activation linked to hallucinogenic effects), has been re-examined because recent studies in healthy volunteers and in selected clinical populations suggest it can safely induce profound subjective experiences and, in some settings, durable improvements in well‑being. Grob and colleagues conducted the present investigation to explore the safety and preliminary efficacy of a moderate dose of psilocybin for anxiety reactive to advanced-stage cancer. The study aimed to assess physiological safety during sessions, acute subjective effects, and changes in mood and anxiety over a 6-month follow-up period using within-subject, double-blind, placebo-controlled methods in a small clinical sample. By reviving a controlled approach to this question, the study sought to establish feasibility and to inform the design of future trials.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
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- APA Citation
Grob, C. S., Danforth, A. L., Chopra, G. S., Hagerty, M., McKay, C. R., Halberstadt, A. L., & Greer, G. R. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Archives of General Psychiatry, 68(1), 71. https://doi.org/10.1001/archgenpsychiatry.2010.116
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