Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Charles S. Grob, MD; Alicia L. Danforth, MA; Gurpreet S. Chopra, MD; Marycie Hagerty, RN, BSN, MA; Charles R. McKay, MD; Adam L. Halberstadt, PhD; George R. Greer, MD

Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Charles S. Grob, MD; Alicia L. Danforth, MA; Gurpreet S. Chopra, MD; Marycie Hagerty, RN, BSN, MA; Charles R. McKay, MD; Adam L. Halberstadt, PhD; George R. Greer, MD

Context: Researchers conducted extensive investiga- tions of hallucinogens in the 1950s and 1960s. By the early 1970s, however, political and cultural pressures forced the cessation of all projects. This investigation reexam- ines a potentially promising clinical application of hal- lucinogens in the treatment of anxiety reactive to ad- vanced-stage cancer.

Objective: To explore the safety and efficacy of psilo- cybin in patients with advanced-stage cancer and reac- tive anxiety.

Design: A double-blind, placebo-controlled study of pa- tients with advanced-stage cancer and anxiety, with sub- jects 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 can- cer and anxiety.

Main Outcome Measures: In addition to monitor- ing safety and subjective experience before and during experimental treatment sessions, follow-up data includ- ing 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 re- sponses were documented during treatment sessions. There were no clinically significant adverse events with psilocybin. The State-Trait Anxiety Inventory trait anxi- ety subscale demonstrated a significant reduction in anxi- ety at 1 and 3 months after treatment. The Beck Depres- sion Inventory revealed an improvement of mood that reached significance at 6 months; the Profile of Mood States identified mood improvement after treatment with psi- locybin 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

Arch Gen Psychiatry. Published online September 6, 2010. doi:10.1001/archgenpsychiatry.2010.116

Author Affiliations: Departments of Psychiatry (Drs Grob and Chopra) and Internal Medicine (Dr McKay), Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance (Drs Grob and McKay and Mss Danforth and Hagerty) and Department of Psychiatry, University of California, San Diego, La Jolla (Dr Halberstadt); and Heffter Research Institute, Santa Fe, New Mexico (Dr Greer).

N RECENT YEARS, THERE HAS BEEN a growing awareness that the psy- chological, spiritual, and existen- tial crises often encountered by pa- tients with cancer and the

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