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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | Drug intervention |
|
| Niacin | Active Comparator | Active control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Death Anxiety Scale | 0-15 (higher score more death anxiety) | 26 weeks post drug administration 2 |
| Death Anxiety Scale | 0-15 (higher score more death anxiety) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU College of Dentistry Bluestone Center for Clinical Research | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31916890 | Derived | 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. | |
| 27909164 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psilocybin First, Then 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. |
| FG001 | Niacin First, Then Psilocybin | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psilocybin First, Then Niacin | Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg |
| BG001 | Niacin First, Then Psilocybin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HADS Anxiety | Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psilocybin | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ross, MD | NYU Langone Health | 212-263-7264 | Stephen.Ross@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 | Feb 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| 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 |
|
| 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 |
| 2 weeks post drug administration 1 |
| Death Transcendence Scale | 0-60 (higher score more death transcendence) | 2-4 weeks prior to drug administration/ Baseline |
| Hopelessness | 0-16 (higher score more hopeless) | Baseline |
| Death Anxiety Scale | 0-15 (higher score more death anxiety) | 2-4 weeks prior to drug administration/ Baseline |
| Death Transcendence Scale | 0-60 (higher score more death transcendence) | 2 weeks post drug administration 1 |
| Hopelessness | 0-16 (higher score more hopeless) | 2 weeks post drug administration 1 |
| Hopelessness | 0-16 (higher score more hopeless) | 26 weeks post drug administration 2 |
| Demoralization Scale | 0-96 (higher score more demoralized) | 2-4 weeks prior to drug administration/ Baseline |
| Demoralization Scale | 0-96 (higher score more demoralized) | 2 weeks post drug administration 1 |
| Demoralization Scale | 0-96 (higher score more demoralized) | 26 weeks post drug administration 2 |
| QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | 2-4 weeks prior to drug administration/ Baseline |
| QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | 2 weeks post drug administration 1 |
| QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | 26 weeks post drug administration 2 |
| QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | 2-4 weeks prior to drug administration/ Baseline |
| QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | 2 weeks post drug administration 1 |
| QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | 26 weeks post drug administration 2 |
| QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | 2-4 weeks prior to drug administration/ Baseline |
| QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | 2 weeks post drug administration 1 |
| QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | 26 weeks post drug administration 2 |
| QoL Environment Scale | 4-20 (higher score improved quality of life domain) | 2-4 weeks prior to drug administration/ Baseline |
| QoL Environment Scale | 4-20 (higher score improved quality of life domain) | 2 weeks post drug administration 1 |
| QoL Environment Scale | 4-20 (higher score improved quality of life domain) | 26 weeks post drug administration 2 |
| 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. |
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
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | HADS Anxiety | Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 1 day post drug administration 1 |
|
|
|
| Primary | HADS Depression | 0-21 (higher score more depression) | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
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|
| 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). | Posted | Mean | Standard Error | score on a scale | 1 day prior to drug administration 1 |
|
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| 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). | Posted | Mean | Standard Error | score on a scale | 1 day post drug administration 1 |
|
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| 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). | Posted | Mean | Standard Error | score on a scale | 6 weeks post drug administration 1 |
|
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| 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). | Posted | Mean | Standard Error | score on a scale | 1 day prior to drug administration 2 |
|
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| 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). | Posted | Mean | Standard Error | score on a scale | 1 day post drug administration 2 |
|
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|
| 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). | Posted | Mean | Standard Error | score on a scale | 6 weeks prior to drug administration 2 |
|
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| 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). | Posted | Mean | Standard Error | score on a scale | 6 weeks post drug administration 2 |
|
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|
| Primary | HADS Depression | 0-21 (higher score more depression) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 6 weeks post drug administration 1 |
|
|
|
| Primary | HADS Anxiety | 0-21 (higher score more anxiety) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 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) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
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|
| Secondary | Death Anxiety Scale | 0-15 (higher score more death anxiety) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
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| Secondary | Death Anxiety Scale | 0-15 (higher score more death anxiety) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
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|
| Secondary | Death Transcendence Scale | 0-60 (higher score more death transcendence) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
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|
| Secondary | Hopelessness | 0-16 (higher score more hopeless) | Posted | Mean | Standard Error | score on a scale | Baseline |
|
|
|
| Secondary | Death Anxiety Scale | 0-15 (higher score more death anxiety) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | Death Transcendence Scale | 0-60 (higher score more death transcendence) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | Hopelessness | 0-16 (higher score more hopeless) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | Hopelessness | 0-16 (higher score more hopeless) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| Secondary | Demoralization Scale | 0-96 (higher score more demoralized) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | Demoralization Scale | 0-96 (higher score more demoralized) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | Demoralization Scale | 0-96 (higher score more demoralized) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| Secondary | QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | QoL Physical Health Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| Secondary | QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | QoL Psychological Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| Secondary | QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | QoL Social Relationships Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| Secondary | QoL Environment Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2-4 weeks prior to drug administration/ Baseline |
|
|
|
| Secondary | QoL Environment Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 2 weeks post drug administration 1 |
|
|
|
| Secondary | QoL Environment Scale | 4-20 (higher score improved quality of life domain) | Posted | Mean | Standard Error | score on a scale | 26 weeks post drug administration 2 |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 0 | 29 |
| elevations in BP and HR | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |