Psilocybin Cancer Anxiety Study

• 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: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Drug: Psilocybin; Drug: Niacin	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
• Actual Study Start Date: February 2009
• Actual Primary Completion Date: September 6, 2018
• Actual Study Completion Date: September 6, 2018

Arms and Interventions

Arm	Intervention/treatment
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; 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
Active Comparator: Niacin; Active control	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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 76 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, New York

NYU College of Dentistry Bluestone Center for Clinical Research

New York, New York, United States, 10010

Sponsors and Collaborators

NYU Langone Health

Investigators

• 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

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol and Statistical Analysis Plan  [PDF] March 21, 2018

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Agin-Liebes GI, Malone T, Yalch MM, Mennenga SE, Ponte KL, Guss J, Bossis AP, Grigsby J, Fischer S, Ross S. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol. 2020 Feb;34(2):155-166. doi: 10.1177/0269881119897615. Epub 2020 Jan 9.

Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00957359
• Other Study ID Numbers: 06-954
• First Posted: August 12, 2009
• Results First Posted: October 3, 2019
• Last Update Posted: October 20, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

Cancer; Anxiety; Depression; Hallucinogens

Additional relevant MeSH terms:

Psilocybin; Niacin; N,N-Dimethyltryptamine; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs; Hallucinogens; Psychotropic Drugs; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Serotonin Receptor Agonists