Psilocybin Cancer Anxiety Study

Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00957359

Enrollment

Registered

2009-08-12

Start date

2009-02-28

Completion date

2018-09-06

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Anxiety, Depression, Hallucinogens

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.

Interventions

DRUGPsilocybin

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

DRUGNiacin

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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
HADS Anxiety	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)
State-Trait Anxiety Inventory (STAI) State	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	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).
HADS Depression	2-4 weeks prior to drug administration/ Baseline	0-21 (higher score more depression)
STAI Trait	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).

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Psilocybin First, Then Niacin Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg	14
Niacin First, Then Psilocybin 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	15
Total	29

Baseline characteristics

Characteristic	Psilocybin First, Then Niacin	Total	Niacin First, Then Psilocybin
Age, Customized Age	52 Years STANDARD_DEVIATION 15.03	56.28 Years STANDARD_DEVIATION 12.93	60.27 Years STANDARD_DEVIATION 9.45
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) White	13 Participants	26 Participants	13 Participants
Region of Enrollment United States	14 Participants	29 Participants	15 Participants
Sex: Female, Male Female	7 Participants	18 Participants	11 Participants
Sex: Female, Male Male	7 Participants	11 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 29
other Total, other adverse events	1 / 29	0 / 29
serious Total, serious adverse events	0 / 29	0 / 29

Outcome results

Primary

HADS Anxiety

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

Time frame: 6 weeks post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	3.60 score on a scale	Standard Error 0.9
Niacin First, Then Psilocybin	HADS Anxiety	5.54 score on a scale	Standard Error 0.89

Primary

HADS Anxiety

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

Time frame: 2-4 weeks prior to drug administration

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	15.14 score on a scale	Standard Error 1.88
Niacin First, Then Psilocybin	HADS Anxiety	16.93 score on a scale	Standard Error 1.81

Primary

HADS Anxiety

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

Time frame: 1 day prior to drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	9.0 score on a scale	Standard Error 0.83
Niacin First, Then Psilocybin	HADS Anxiety	9.0 score on a scale	Standard Error 0.8

Primary

HADS Anxiety

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

Time frame: 1 day post drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	3.43 score on a scale	Standard Error 0.83
Niacin First, Then Psilocybin	HADS Anxiety	6.0 score on a scale	Standard Error 0.8

Primary

HADS Anxiety

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

Time frame: 6 weeks post drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	4.64 score on a scale	Standard Error 0.83
Niacin First, Then Psilocybin	HADS Anxiety	8.44 score on a scale	Standard Error 0.82

Primary

HADS Anxiety

0-21 (higher score more anxiety)

Time frame: 1 day post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	6.84 score on a scale	Standard Error 0.69
Niacin First, Then Psilocybin	HADS Anxiety	13.02 score on a scale	Standard Error 1.85

Primary

HADS Anxiety

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

Time frame: 26 weeks post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	2.69 score on a scale	Standard Error 0.92
Niacin First, Then Psilocybin	HADS Anxiety	4.70 score on a scale	Standard Error 0.89

Primary

HADS Anxiety

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

Time frame: 1 day prior to drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Anxiety	4.57 score on a scale	Standard Error 0.88
Niacin First, Then Psilocybin	HADS Anxiety	7.98 score on a scale	Standard Error 0.83

Primary

HADS Depression

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

Time frame: 26 weeks post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	6.48 score on a scale	Standard Error 2.04
Niacin First, Then Psilocybin	HADS Depression	9.06 score on a scale	Standard Error 1.97

Primary

HADS Depression

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

Time frame: 6 weeks post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	6.31 score on a scale	Standard Error 1.99
Niacin First, Then Psilocybin	HADS Depression	9.65 score on a scale	Standard Error 1.95

Primary

HADS Depression

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

Time frame: 1 day post drug administration 2

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	5.25 score on a scale	Standard Error 1.97
Niacin First, Then Psilocybin	HADS Depression	10.05 score on a scale	Standard Error 1.86

Primary

HADS Depression

0-21 (higher score more depression)

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

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	5.29 score on a scale	Standard Error 0.92
Niacin First, Then Psilocybin	HADS Depression	7 score on a scale	Standard Error 0.89

Primary

HADS Depression

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

Time frame: 1 day post drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	4.21 score on a scale	Standard Error 1.88
Niacin First, Then Psilocybin	HADS Depression	12.07 score on a scale	Standard Error 1.81

Primary

HADS Depression

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

Time frame: 6 weeks post drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	6.5 score on a scale	Standard Error 1.88
Niacin First, Then Psilocybin	HADS Depression	14.24 score on a scale	Standard Error 1.84

Primary

HADS Depression

0-21 (higher score more depression)

Time frame: 1 day prior to drug administration 1

Arm	Measure	Value (MEAN)	Dispersion
Psilocybin First, Then Niacin	HADS Depression	10.43 score on a scale	Standard Error 1.88
Niacin First, Then Psilocybin	HADS Depression	16.47 score on a scale	Standard Error 1.81

Primary