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

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.

[1]  Janet B W Williams,et al.  Diagnostic and Statistical Manual of Mental Disorders , 2013 .

[2]  J. Bakalar,et al.  Psychedelic Drugs Reconsidered , 1979 .

[3]  J. Holland,et al.  A brief POMS measure of distress for cancer patients. , 1987, Journal of chronic diseases.

[4]  G. Fisher.  Death, Identity, and Creativity , 1972 .

[5]  P. Rousseau.  Spirituality and the dying patient. , 2000, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  Felix Hasler,et al.  Acute psychological and physiological effects of psilocybin in healthy humans : a double-blind , placebo-controlled dose – effect study , 2004 .

[7]  W. Richards,et al.  LSD-assisted psychotherapy in patients with terminal cancer. , 1973, International pharmacopsychiatry.

[8]  E. Kast,et al.  Study of Lysergic Acid Diethylamide as an Analgesic Agent , 1964, Anesthesia and analgesia.

[9]  W. Breitbart,et al.  Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. , 2000, JAMA.

[10]  R. Griffiths,et al.  Human hallucinogen research: guidelines for safety , 2008, Journal of psychopharmacology.

[11]  B. Sepúlveda.  [Concept of death]. , 1969, Gaceta medica de Mexico.

[12]  H. Emrich,et al.  The pharmacology of psilocybin , 2002, Addiction biology.

[13]  A. Weil,et al.  Hallucinogens: A Reader , 2002 .

[14]  Franz X Vollenweider,et al.  The Effects of the Preferential 5-HT2A Agonist Psilocybin on Prepulse Inhibition of Startle in Healthy Human Volunteers Depend on Interstimulus Interval , 2007, Neuropsychopharmacology.

[15]  I. Sulg.  [The concept of death]. , 1974, Tidskrift for Sveriges sjukskoterskor.

[16]  E. Kast.  The measurement of pain: a new approach to an old problem. , 1962, The Journal of new drugs.

[17]  H. Chochinov.  Psychiatry and Terminal Illness , 2000, Canadian journal of psychiatry. Revue canadienne de psychiatrie.

[18]  D. Rader,et al.  Does nicotinic acid (niacin) lower blood pressure? , 2009, International journal of clinical practice.

[19]  C. Spielberger.  State‐Trait Anxiety Inventory , 2010 .

[20]  J. Overall,et al.  The Brief Psychiatric Rating Scale , 1962 .

[21]  W. Pahnke.  The Psychedelic Mystical Experience in the Human Encounter with Death , 1969, Harvard Theological Review.

[22]  E. Kast.  LSD and the dying patient. , 1966, The Chicago Medical School quarterly.

[23]  R. Griffiths,et al.  Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance , 2006, Psychopharmacology.

[24]  C. Grob.  Psychiatric Research with Hallucinogens: What have we learned? , 2010 .

[25]  P. Delgado,et al.  Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. , 2006, The Journal of clinical psychiatry.

[26]  D. Lukoff.  Higher Wisdom: Eminent Elders Explore the Continuing Impact of Psychedelics , 2006 .

[27]  G. Fisher.  Psychotherapy for the Dying: Principles and Illustrative Cases with Special Reference to the use of LSD , 1970 .

[28]  A. Beck,et al.  An inventory for measuring depression. , 1961, Archives of general psychiatry.

[29]  W. Breitbart,et al.  Psychotherapeutic Interventions at the End of Life: A Focus on Meaning and Spirituality , 2004, Canadian journal of psychiatry. Revue canadienne de psychiatrie.

[30]  F. Vollenweider,et al.  Positron Emission Tomography and Fluorodeoxyglucose Studies of Metabolic Hyperfrontality and Psychopathology in the Psilocybin Model of Psychosis , 1997, Neuropsychopharmacology.

[31]  W. Richards,et al.  LSD-assisted psychotherapy and the human encounter with death. , 1972 .