Psilocybin Cancer Anxiety Study

NCT00957359 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 06-954
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Anxiety; Depression; Hallucinogens

Outcome Measures

Primary Outcomes (31)

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  2-4 weeks prior to drug administration

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  1 day prior to drug administration 1

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  1 day post drug administration 1

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  6 weeks post drug administration 1

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  1 day prior to drug administration 2

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  6 weeks post drug administration 2

• HADS Anxiety

  Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)

  26 weeks post drug administration 2

• State-Trait Anxiety Inventory (STAI) State

  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).

  2-4 weeks prior to drug administration/ Baseline

• STAI State

  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).

  1 day prior to drug administration 1

• STAI State

  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).

  1 day post drug administration 1

• HADS Depression

  0-21 (higher score more depression)

  2-4 weeks prior to drug administration/ Baseline

• STAI State

  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).

  6 weeks post drug administration 1

• STAI State

  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).

  1 day prior to drug administration 2

• STAI State

  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).

  1 day post drug administration 2

• STAI State

  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).

  6 weeks post drug administration 2

• STAI State

  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).

  26 weeks post drug administration 2

• STAI Trait

  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).

  2-4 weeks prior to drug administration/ Baseline

• STAI Trait

  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).

  1 day prior to drug administration 1

• STAI Trait

  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).

  1 day post drug administration 1

• STAI Trait

  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).

  6 weeks post drug administration 1

• STAI Trait

  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).

  1 day prior to drug administration 2

• STAI Trait

  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).

  1 day post drug administration 2

• STAI Trait

  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).

  6 weeks prior to drug administration 2

• STAI Trait

  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).

  6 weeks post drug administration 2

• HADS Depression

  0-21 (higher score more depression)

  1 day prior to drug administration 1

• HADS Depression

  Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

  1 day post drug administration 1

• HADS Depression

  Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

  6 weeks post drug administration 1

• HADS Anxiety

  0-21 (higher score more anxiety)

  1 day post drug administration 2

• HADS Depression

  Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

  1 day post drug administration 2

• HADS Depression

  Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

  6 weeks post drug administration 2

• HADS Depression

  Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)

  26 weeks post drug administration 2

Secondary Outcomes (23)

• Death Anxiety Scale

  26 weeks post drug administration 2

• Death Anxiety Scale

  2 weeks post drug administration 1

• Death Transcendence Scale

  2-4 weeks prior to drug administration/ Baseline

• Hopelessness

  Baseline

• Death Anxiety Scale

  2-4 weeks prior to drug administration/ Baseline

Study Arms (2)

Psilocybin

EXPERIMENTAL

Drug intervention

Drug: Psilocybin; Drug: Niacin

Niacin

ACTIVE COMPARATOR

Active control

Drug: Psilocybin; Drug: Niacin

Interventions

Psilocybin DRUG

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

Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine

Niacin; Psilocybin

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

Niacin; Psilocybin

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU College of Dentistry Bluestone Center for Clinical Research

New York, New York, 10010, United States

Location

Related Publications (2)

• 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.

  PMID: 31916890 DERIVED

• 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.

  PMID: 27909164 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Interventions

Psilocybin; Niacin

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Stephen Ross, MD
• Organization: NYU Langone Health

Stephen.Ross@nyulangone.org

212-263-7264

Study Officials

• Stephen Ross, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Anthony Bossis, PhD

  Co-Principal Investigator NYU Langone School of Medicine

  STUDY CHAIR

• Jeffrey Guss, MD

  Co-Principal Investigator NYU Langone School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: February 1, 2009
• Primary Completion: September 6, 2018
• Study Completion: September 6, 2018
• Last Updated: October 20, 2020
• Results First Posted: October 3, 2019

Record last verified: 2020-09

Locations

US (1)