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


METHODS
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.


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


METHODS
Twelve adults with advanced-stage cancer and anxiety.


METHODS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00302744.
Grob
Charles S
CS
Department of Psychiatry, Harbor-UCLA Medical Center, Torrance, CA 90509, USA. cgrob@labiomed.org
Danforth
Alicia L
AL
Chopra
Gurpreet S
GS
Hagerty
Marycie
M
McKay
Charles R
CR
Halberstadt
Adam L
AL
Greer
George R
GR
D000328:Adult; D000339:Affect; D001007:Anxiety / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006213:Hallucinogens / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology*; D010555:Personality Inventory; D010865:Pilot Projects; D011562:Psilocybin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D006213:Hallucinogens; D011562:Psilocybin