Overview

This trial is active, not recruiting.

Condition cancer
Treatment psilocybin
Phase phase 1/phase 2
Sponsor New York University
Start date February 2009
End date October 2014
Trial size 32 participants
Trial identifier NCT00957359, 06-954

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Drug intervention
psilocybin 4-phosphoryloxy-N,N-dimethyltryptamine
Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg

Primary Outcomes

Measure
anxiety
time frame: 2-4 weeks prior to drug administration
anxiety
time frame: 1 day prior to drug administration
anxiety
time frame: 7 hours post drug administration
anxiety
time frame: 1 day post drug administration
anxiety
time frame: 2 weeks post drug administration
anxiety
time frame: 6 weeks post drug administration
anxiety
time frame: 10 weeks post drug administration
anxiety
time frame: 14 weeks post drug administration
anxiety
time frame: 18 weeks post drug administration
anxiety
time frame: 22 weeks post drug administration
anxiety
time frame: 26 weeks post drug administration

Secondary Outcomes

Measure
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
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
Quality of Life
time frame: 2-4 weeks prior to drug adminisration, and 2 weeks/26 weeks post drug administration
Attitude toward disease progression
time frame: 2-4 weeks prior to drug administration and 2 weeks/26 weeks post drug administration

Eligibility Criteria

Male or female participants from 18 years up to 76 years old.

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

Additional Information

Official title Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
Principal investigator Stephen Ross, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by New York University.