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Psilocybin Cancer Anxiety Study

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ClinicalTrials.gov Identifier: NCT00957359
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : October 3, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 11, 2009
First Posted Date  ICMJE August 12, 2009
Results First Submitted Date  ICMJE February 19, 2019
Results First Posted Date  ICMJE October 3, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE February 2009
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • HADS Anxiety [ Time Frame: 2-4 weeks prior to drug administration ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 1 day prior to drug administration 1 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 1 day post drug administration 1 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 6 weeks post drug administration 1 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 1 day prior to drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 6 weeks post drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • HADS Anxiety [ Time Frame: 26 weeks post drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
  • State-Trait Anxiety Inventory (STAI) State [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 1 day prior to drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 1 day post drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • HADS Depression [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    0-21 (higher score more depression)
  • STAI State [ Time Frame: 6 weeks post drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 1 day prior to drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 1 day post drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 6 weeks post drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI State [ Time Frame: 26 weeks post drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 1 day prior to drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 1 day post drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 6 weeks post drug administration 1 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 1 day prior to drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 1 day post drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 6 weeks prior to drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • STAI Trait [ Time Frame: 6 weeks post drug administration 2 ]
    STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
  • HADS Depression [ Time Frame: 1 day prior to drug administration 1 ]
    0-21 (higher score more depression)
  • HADS Depression [ Time Frame: 1 day post drug administration 1 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
  • HADS Depression [ Time Frame: 6 weeks post drug administration 1 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
  • HADS Anxiety [ Time Frame: 1 day post drug administration 2 ]
    0-21 (higher score more anxiety)
  • HADS Depression [ Time Frame: 1 day post drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
  • HADS Depression [ Time Frame: 6 weeks post drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
  • HADS Depression [ Time Frame: 26 weeks post drug administration 2 ]
    Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2009)
anxiety [ 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Death Anxiety Scale [ Time Frame: 26 weeks post drug administration 2 ]
    0-15 (higher score more death anxiety)
  • Death Anxiety Scale [ Time Frame: 2 weeks post drug administration 1 ]
    0-15 (higher score more death anxiety)
  • Death Transcendence Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    0-60 (higher score more death transcendence)
  • Hopelessness [ Time Frame: Baseline ]
    0-16 (higher score more hopeless)
  • Death Anxiety Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    0-15 (higher score more death anxiety)
  • Death Transcendence Scale [ Time Frame: 2 weeks post drug administration 1 ]
    0-60 (higher score more death transcendence)
  • Hopelessness [ Time Frame: 2 weeks post drug administration 1 ]
    0-16 (higher score more hopeless)
  • Hopelessness [ Time Frame: 26 weeks post drug administration 2 ]
    0-16 (higher score more hopeless)
  • Demoralization Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    0-96 (higher score more demoralized)
  • Demoralization Scale [ Time Frame: 2 weeks post drug administration 1 ]
    0-96 (higher score more demoralized)
  • Demoralization Scale [ Time Frame: 26 weeks post drug administration 2 ]
    0-96 (higher score more demoralized)
  • QoL Physical Health Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    4-20 (higher score improved quality of life domain)
  • QoL Physical Health Scale [ Time Frame: 2 weeks post drug administration 1 ]
    4-20 (higher score improved quality of life domain)
  • QoL Physical Health Scale [ Time Frame: 26 weeks post drug administration 2 ]
    4-20 (higher score improved quality of life domain)
  • QoL Psychological Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    4-20 (higher score improved quality of life domain)
  • QoL Psychological Scale [ Time Frame: 2 weeks post drug administration 1 ]
    4-20 (higher score improved quality of life domain)
  • QoL Psychological Scale [ Time Frame: 26 weeks post drug administration 2 ]
    4-20 (higher score improved quality of life domain)
  • QoL Social Relationships Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    4-20 (higher score improved quality of life domain)
  • QoL Social Relationships Scale [ Time Frame: 2 weeks post drug administration 1 ]
    4-20 (higher score improved quality of life domain)
  • QoL Social Relationships Scale [ Time Frame: 26 weeks post drug administration 2 ]
    4-20 (higher score improved quality of life domain)
  • QoL Environment Scale [ Time Frame: 2-4 weeks prior to drug administration/ Baseline ]
    4-20 (higher score improved quality of life domain)
  • QoL Environment Scale [ Time Frame: 2 weeks post drug administration 1 ]
    4-20 (higher score improved quality of life domain)
  • QoL Environment Scale [ Time Frame: 26 weeks post drug administration 2 ]
    4-20 (higher score improved quality of life domain)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin Cancer Anxiety Study
Official Title  ICMJE Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • 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
  • Drug: Niacin
    Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
Study Arms  ICMJE
  • Experimental: Psilocybin
    Drug intervention
    Interventions:
    • Drug: Psilocybin
    • Drug: Niacin
  • Active Comparator: Niacin
    Active control
    Interventions:
    • Drug: Psilocybin
    • Drug: Niacin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2009)
32
Actual Study Completion Date  ICMJE September 6, 2018
Actual Primary Completion Date September 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00957359
Other Study ID Numbers  ICMJE 06-954
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Ross, MD NYU Langone Health
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
PRS Account NYU Langone Health
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP