Psilocybin Cancer Anxiety Study

Cancer Clinical Trial

Official title:

Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957359
• Other study ID #: 06-954
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2009
• Est. completion date: September 6, 2018

Study information

• Verified date: September 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	NYU College of Dentistry Bluestone Center for Clinical Research	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	HADS Depression	0-21 (higher score more depression)	2-4 weeks prior to drug administration/ Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	HADS Depression	0-21 (higher score more depression)	1 day prior to drug administration 1
Primary	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
Primary	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
Primary	HADS Anxiety	0-21 (higher score more anxiety)	1 day post drug administration 2
Primary	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
Primary	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
Primary	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	Death Anxiety Scale	0-15 (higher score more death anxiety)	26 weeks post drug administration 2
Secondary	Death Anxiety Scale	0-15 (higher score more death anxiety)	2 weeks post drug administration 1
Secondary	Death Transcendence Scale	0-60 (higher score more death transcendence)	2-4 weeks prior to drug administration/ Baseline
Secondary	Hopelessness	0-16 (higher score more hopeless)	Baseline
Secondary	Death Anxiety Scale	0-15 (higher score more death anxiety)	2-4 weeks prior to drug administration/ Baseline
Secondary	Death Transcendence Scale	0-60 (higher score more death transcendence)	2 weeks post drug administration 1
Secondary	Hopelessness	0-16 (higher score more hopeless)	2 weeks post drug administration 1
Secondary	Hopelessness	0-16 (higher score more hopeless)	26 weeks post drug administration 2
Secondary	Demoralization Scale	0-96 (higher score more demoralized)	2-4 weeks prior to drug administration/ Baseline
Secondary	Demoralization Scale	0-96 (higher score more demoralized)	2 weeks post drug administration 1
Secondary	Demoralization Scale	0-96 (higher score more demoralized)	26 weeks post drug administration 2
Secondary	QoL Physical Health Scale	4-20 (higher score improved quality of life domain)	2-4 weeks prior to drug administration/ Baseline
Secondary	QoL Physical Health Scale	4-20 (higher score improved quality of life domain)	2 weeks post drug administration 1
Secondary	QoL Physical Health Scale	4-20 (higher score improved quality of life domain)	26 weeks post drug administration 2
Secondary	QoL Psychological Scale	4-20 (higher score improved quality of life domain)	2-4 weeks prior to drug administration/ Baseline
Secondary	QoL Psychological Scale	4-20 (higher score improved quality of life domain)	2 weeks post drug administration 1
Secondary	QoL Psychological Scale	4-20 (higher score improved quality of life domain)	26 weeks post drug administration 2
Secondary	QoL Social Relationships Scale	4-20 (higher score improved quality of life domain)	2-4 weeks prior to drug administration/ Baseline
Secondary	QoL Social Relationships Scale	4-20 (higher score improved quality of life domain)	2 weeks post drug administration 1
Secondary	QoL Social Relationships Scale	4-20 (higher score improved quality of life domain)	26 weeks post drug administration 2
Secondary	QoL Environment Scale	4-20 (higher score improved quality of life domain)	2-4 weeks prior to drug administration/ Baseline
Secondary	QoL Environment Scale	4-20 (higher score improved quality of life domain)	2 weeks post drug administration 1
Secondary	QoL Environment Scale	4-20 (higher score improved quality of life domain)	26 weeks post drug administration 2

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