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Completed

NCT Number: NCT00957359

Psilocybin Cancer Anxiety Study

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.

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Key information

Conditions

Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neoplasms

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYU College of Dentistry Bluestone Center for Clinical Research

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg

Other names: 4-phosphoryloxy-N,N-dimethyltryptamine

niacin

Drug

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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).

  9. 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).

  10. 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).

  11. HADS Depression

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    0-21 (higher score more depression)

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

  21. 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).

  22. 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).

  23. 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).

  24. 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).

  25. HADS Depression

    Time frame: 1 day prior to drug administration 1

    0-21 (higher score more depression)

  26. 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)

  27. 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)

  28. HADS Anxiety

    Time frame: 1 day post drug administration 2

    0-21 (higher score more anxiety)

  29. 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)

  30. 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)

  31. 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)

Secondary outcomes

  1. Death Anxiety Scale

    Time frame: 26 weeks post drug administration 2

    0-15 (higher score more death anxiety)

  2. Death Anxiety Scale

    Time frame: 2 weeks post drug administration 1

    0-15 (higher score more death anxiety)

  3. Death Transcendence Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    0-60 (higher score more death transcendence)

  4. Hopelessness

    Time frame: Baseline

    0-16 (higher score more hopeless)

  5. Death Anxiety Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    0-15 (higher score more death anxiety)

  6. Death Transcendence Scale

    Time frame: 2 weeks post drug administration 1

    0-60 (higher score more death transcendence)

  7. Hopelessness

    Time frame: 2 weeks post drug administration 1

    0-16 (higher score more hopeless)

  8. Hopelessness

    Time frame: 26 weeks post drug administration 2

    0-16 (higher score more hopeless)

  9. Demoralization Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    0-96 (higher score more demoralized)

  10. Demoralization Scale

    Time frame: 2 weeks post drug administration 1

    0-96 (higher score more demoralized)

  11. Demoralization Scale

    Time frame: 26 weeks post drug administration 2

    0-96 (higher score more demoralized)

  12. QoL Physical Health Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    4-20 (higher score improved quality of life domain)

  13. QoL Physical Health Scale

    Time frame: 2 weeks post drug administration 1

    4-20 (higher score improved quality of life domain)

  14. QoL Physical Health Scale

    Time frame: 26 weeks post drug administration 2

    4-20 (higher score improved quality of life domain)

  15. QoL Psychological Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    4-20 (higher score improved quality of life domain)

  16. QoL Psychological Scale

    Time frame: 2 weeks post drug administration 1

    4-20 (higher score improved quality of life domain)

  17. QoL Psychological Scale

    Time frame: 26 weeks post drug administration 2

    4-20 (higher score improved quality of life domain)

  18. QoL Social Relationships Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    4-20 (higher score improved quality of life domain)

  19. QoL Social Relationships Scale

    Time frame: 2 weeks post drug administration 1

    4-20 (higher score improved quality of life domain)

  20. QoL Social Relationships Scale

    Time frame: 26 weeks post drug administration 2

    4-20 (higher score improved quality of life domain)

  21. QoL Environment Scale

    Time frame: 2-4 weeks prior to drug administration/ Baseline

    4-20 (higher score improved quality of life domain)

  22. QoL Environment Scale

    Time frame: 2 weeks post drug administration 1

    4-20 (higher score improved quality of life domain)

  23. QoL Environment Scale

    Time frame: 26 weeks post drug administration 2

    4-20 (higher score improved quality of life domain)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2009
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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