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.
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Psilocybin (0.2 mg/kg) was safe and associated with significant reduction in trait anxiety at 1 and 3 months and improved mood.
Synthesized
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State of the evidence: Anxiety Supports
Psilocybin was safe and associated with significant reductions in trait anxiety at 1 and 3 months after treatment.
Synthesized
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State of the evidence: Psilocybin Supports
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.