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Arch Gen Psychiatry. 2011 Jan;68(1):71-8. doi: 10.1001/archgenpsychiatry.2010.116. Epub 2010 Sep 6.

Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer.

Author information

  • 1Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, CA 90509, USA. cgrob@labiomed.org

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.

PMID:
20819978
[PubMed - indexed for MEDLINE]
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