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Psilocybin Advanced Cancer Anxiety Study

2014-07-24 14:11:53 | BioPortfolio

Summary

The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with advanced or 'potentially life threatening' cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Bellevue General Clinical Research Center (GCRC), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.

It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported (Grof and Halifax 1977; Kast 1970). However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained (Osmond 1957). Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness ) as a means to facilitate emotional discharge and to manage irreconcilable conflict (Dobkin de Rios, Grob, & Baker 2002).

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cancer

Intervention

Psilocybin

Location

NYU College of Dentistry Bluestone Center for Clinical Research
New York
New York
United States
10010

Status

Recruiting

Source

New York University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:53-0400

Clinical Trials [17 Associated Clinical Trials listed on BioPortfolio]

Psychopharmacology of Psilocybin in Cancer Patients

This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures h...

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.

This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeut...

Effects of Psilocybin in Major Depressive Disorder

The proposed pilot study will assess whether people with major depressive disorder experience psychological and behavioral benefits and/or harms from psilocybin. This study will investigat...

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

Psychiatric Research Study For Cancer Patients The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of t...

Psilocybin for Treatment of Obsessive Compulsive Disorder

This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will i...

PubMed Articles [13274 Associated PubMed Articles listed on BioPortfolio]

Production options for psilocybin - the making of the magic.

The fungal genus Psilocybe and other genera comprise numerous mushroom species that biosynthesize psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine). It represents the prodrug to its dephosphorylated...

The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act.

This review assesses the abuse potential of medically-administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safet...

Biocatalytic production of psilocybin and derivatives in tryptophan synthase-enhanced reactions.

Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine) is the main alkaloid of the fungal genus Psilocybe, the so-called "magic mushrooms". The pharmaceutical interest in this psychotropic natural produc...

What Psilocybin Taught Me About Dying.

Iterative L-tryptophan methylation in Psilocybe evolved by sub-domain duplication.

Psilocybe mushrooms are best known for their L-tryptophan-derived psychotropic alkaloid psilocybin. The dimethylation of its precursor norbaeocystin by the enzyme PsiM is a critical step during its bi...

Medical and Biotech [MESH] Definitions

The major of two hallucinogenic components of Teonanacatl, the sacred mushroom of Mexico, the other component being psilocin. (From Merck Index, 11th ed)

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

That portion of the stomach remaining after gastric surgery, usually gastrectomy or gastroenterostomy for cancer of the stomach or peptic ulcer. It is a common site of cancer referred to as stump cancer or carcinoma of the gastric stump.

A voluntary organization concerned with the prevention and treatment of cancer through education and research.

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