Psilocybin Cancer Anxiety Study

This study is currently recruiting participants.
Verified July 2012 by New York University
Sponsor:
Information provided by (Responsible Party):
Stephen Ross, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00957359
First received: August 11, 2009
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 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 Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), 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. 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. 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.


Condition Intervention Phase
Cancer
Drug: Psilocybin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • anxiety [ Time Frame: 2-4 weeks prior to drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 1 day prior to drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 7 hours post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 1 day post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 2 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 6 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 10 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 14 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 18 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 22 weeks post drug administration ] [ Designated as safety issue: Yes ]
  • anxiety [ Time Frame: 26 weeks post drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • depression [ Time Frame: 2-4 weeks prior to drug administration, 1 day before drug administration, and 7 hours/1day/2weeks/6weeks/10weeks/14weeks/18weeks/22weeks/26 weeks post drug administrtion ] [ Designated as safety issue: Yes ]
  • pain [ Time Frame: Starting at study entry, daily until 6 weeks after drug administration and then at 10 weeks/14weeks/18weeks/22weeks/26 weeks post drug administration ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 2-4 weeks prior to drug adminisration, and 2 weeks/26 weeks post drug administration ] [ Designated as safety issue: No ]
  • Attitude toward disease progression [ Time Frame: 2-4 weeks prior to drug administration and 2 weeks/26 weeks post drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: February 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psilocybin
Drug intervention
Drug: Psilocybin
Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
Other Name: 4-phosphoryloxy-N,N-dimethyltryptamine

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-76
  • Current or historical diagnosis of cancer
  • Projected life expectancy of at least one year
  • DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features
  • Any stage of cancer diagnosis

Exclusion Criteria:

  • Epilepsy
  • Renal disease
  • Diabetes
  • Abnormal liver function
  • Severe cardiovascular disease
  • Malignant Hypertension
  • Baseline blood pressure must be less than or equal to 140/90
  • Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness
  • Current substance use disorder
  • Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957359

Contacts
Contact: Gabrielle Agin-Liebes, BA 646-501-4206 gabrielle.agin-liebes@nyumc.org
Contact: Stephen Ross, MD 212-562-4097 stephen.ross@nyumc.org

Locations
United States, New York
NYU College of Dentistry Bluestone Center for Clinical Research Recruiting
New York, New York, United States, 10010
Contact: Gabrielle Agin-Liebes, BA    646-501-4206    gabrielle.agin-liebes@nyumc.org   
Contact: Patricia Corby, DDS    212-998-9713    patricia.corby@nyu.edu   
Principal Investigator: Stephen Ross, MD         
Sponsors and Collaborators
New York University
Investigators
Principal Investigator: Stephen Ross, MD New York University School of Medicine
Study Chair: Anthony Bossis, PhD Co-Principal Investigator NYU Langone School of Medicine
Study Director: Jeffrey Guss, MD Co-Principal Investigator NYU Langone School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Ross, Director, Division of Alcoholism & Drug Abuse, Bellevue Hospital; Clinical Director, NYU Langone Center of Excellence on Addiction, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00957359     History of Changes
Other Study ID Numbers: 06-954
Study First Received: August 11, 2009
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University:
Cancer
Anxiety
Depression
Hallucinogens

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Hallucinogens
N,N-Dimethyltryptamine
Psilocybine
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on April 17, 2014