Psilocybin Cancer Anxiety Study

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT00957359
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
115.1
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
Early Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 1, 2009
Actual Primary Completion Date :
Sep 6, 2018
Actual Study Completion Date :
Sep 6, 2018

Arms and Interventions

ArmIntervention/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 Names:
  • 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 Names:
  • 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [2-4 weeks prior to drug administration/ Baseline]

      0-21 (higher score more depression)

    12. STAI State [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [1 day prior to drug administration 1]

      0-21 (higher score more depression)

    26. HADS Depression [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 [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 [1 day post drug administration 2]

      0-21 (higher score more anxiety)

    29. HADS Depression [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 [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 [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 [26 weeks post drug administration 2]

      0-15 (higher score more death anxiety)

    2. Death Anxiety Scale [2 weeks post drug administration 1]

      0-15 (higher score more death anxiety)

    3. Death Transcendence Scale [2-4 weeks prior to drug administration/ Baseline]

      0-60 (higher score more death transcendence)

    4. Hopelessness [Baseline]

      0-16 (higher score more hopeless)

    5. Death Anxiety Scale [2-4 weeks prior to drug administration/ Baseline]

      0-15 (higher score more death anxiety)

    6. Death Transcendence Scale [2 weeks post drug administration 1]

      0-60 (higher score more death transcendence)

    7. Hopelessness [2 weeks post drug administration 1]

      0-16 (higher score more hopeless)

    8. Hopelessness [26 weeks post drug administration 2]

      0-16 (higher score more hopeless)

    9. Demoralization Scale [2-4 weeks prior to drug administration/ Baseline]

      0-96 (higher score more demoralized)

    10. Demoralization Scale [2 weeks post drug administration 1]

      0-96 (higher score more demoralized)

    11. Demoralization Scale [26 weeks post drug administration 2]

      0-96 (higher score more demoralized)

    12. QoL Physical Health Scale [2-4 weeks prior to drug administration/ Baseline]

      4-20 (higher score improved quality of life domain)

    13. QoL Physical Health Scale [2 weeks post drug administration 1]

      4-20 (higher score improved quality of life domain)

    14. QoL Physical Health Scale [26 weeks post drug administration 2]

      4-20 (higher score improved quality of life domain)

    15. QoL Psychological Scale [2-4 weeks prior to drug administration/ Baseline]

      4-20 (higher score improved quality of life domain)

    16. QoL Psychological Scale [2 weeks post drug administration 1]

      4-20 (higher score improved quality of life domain)

    17. QoL Psychological Scale [26 weeks post drug administration 2]

      4-20 (higher score improved quality of life domain)

    18. QoL Social Relationships Scale [2-4 weeks prior to drug administration/ Baseline]

      4-20 (higher score improved quality of life domain)

    19. QoL Social Relationships Scale [2 weeks post drug administration 1]

      4-20 (higher score improved quality of life domain)

    20. QoL Social Relationships Scale [26 weeks post drug administration 2]

      4-20 (higher score improved quality of life domain)

    21. QoL Environment Scale [2-4 weeks prior to drug administration/ Baseline]

      4-20 (higher score improved quality of life domain)

    22. QoL Environment Scale [2 weeks post drug administration 1]

      4-20 (higher score improved quality of life domain)

    23. QoL Environment Scale [26 weeks post drug administration 2]

      4-20 (higher score improved quality of life domain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 76 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    SiteCityStateCountryPostal Code
    1NYU College of Dentistry Bluestone Center for Clinical ResearchNew YorkNew YorkUnited States10010

    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)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT00957359
    Other Study ID Numbers:
    • 06-954
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Oct 20, 2020
    Last Verified:
    Sep 1, 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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionPsilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg.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
    Period Title: Overall Study
    STARTED1415
    COMPLETED1415
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then PsilocybinTotal
    Arm/Group DescriptionPsilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kgNiacin: Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mgTotal of all reporting groups
    Overall Participants141529
    Age, Customized (Years) [Mean (Standard Deviation) ]
    Age
    52
    (15.03)
    60.27
    (9.45)
    56.28
    (12.93)
    Sex: Female, Male (Count of Participants)
    Female
    7
    50%
    11
    73.3%
    18
    62.1%
    Male
    7
    50%
    4
    26.7%
    11
    37.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    13
    92.9%
    13
    86.7%
    26
    89.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    7.1%
    2
    13.3%
    3
    10.3%
    Region of Enrollment (Count of Participants)
    United States
    14
    100%
    15
    100%
    29
    100%

    Outcome Measures

    1. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame2-4 weeks prior to drug administration

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.14
    (1.88)
    16.93
    (1.81)
    2. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame1 day prior to drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    9.0
    (.83)
    9.0
    (0.8)
    3. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame1 day post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    3.43
    (.83)
    6.0
    (.80)
    4. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame6 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    4.64
    (.83)
    8.44
    (.82)
    5. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame1 day prior to drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    4.57
    (0.88)
    7.98
    (0.83)
    6. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame6 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    3.60
    (.90)
    5.54
    (.89)
    7. Primary Outcome
    TitleHADS Anxiety
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    2.69
    (.92)
    4.70
    (.89)
    8. Primary Outcome
    TitleState-Trait Anxiety Inventory (STAI) State
    DescriptionSTAI 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).
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    43.79
    (2.83)
    48.53
    (2.12)
    9. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame1 day prior to drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    39.07
    (2.83)
    45.6
    (2.73)
    10. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame1 day post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    27.5
    (2.83)
    40.33
    (2.73)
    11. Primary Outcome
    TitleHADS Depression
    Description0-21 (higher score more depression)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    5.29
    (0.92)
    7
    (0.89)
    12. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame6 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    33.5
    (2.83)
    47.05
    (2.80)
    13. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame1 day prior to drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    32.72
    (2.99)
    45.31
    (2.82)
    14. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame1 day post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    25.73
    (3.04)
    38.11
    (2.83)
    15. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame6 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    30.67
    (3.05)
    37.77
    (3.07)
    16. Primary Outcome
    TitleSTAI State
    DescriptionSTAI 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).
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    28.04
    (3.15)
    38.28
    (3.04)
    17. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    43.79
    (2.83)
    48.53
    (2.12)
    18. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame1 day prior to drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    39.07
    (2.83)
    45.87
    (2.12)
    19. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame1 day post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    27.5
    (2.83)
    44
    (2.12)
    20. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame6 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    33.5
    (2.83)
    46.19
    (2.17)
    21. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame1 day prior to drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    32.72
    (2.99)
    45.31
    (2.82)
    22. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame1 day post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    25.73
    (3.04)
    38.11
    (2.83)
    23. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame6 weeks prior to drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    30.67
    (3.05)
    37.77
    (3.07)
    24. Primary Outcome
    TitleSTAI Trait
    DescriptionSTAI 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).
    Time Frame6 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    28.04
    (3.15)
    38.28
    (3.04)
    25. Primary Outcome
    TitleHADS Depression
    Description0-21 (higher score more depression)
    Time Frame1 day prior to drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    10.43
    (1.88)
    16.47
    (1.81)
    26. Primary Outcome
    TitleHADS Depression
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
    Time Frame1 day post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    4.21
    (1.88)
    12.07
    (1.81)
    27. Primary Outcome
    TitleHADS Depression
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
    Time Frame6 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.5
    (1.88)
    14.24
    (1.84)
    28. Primary Outcome
    TitleHADS Anxiety
    Description0-21 (higher score more anxiety)
    Time Frame1 day post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.84
    (0.69)
    13.02
    (1.85)
    29. Primary Outcome
    TitleHADS Depression
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
    Time Frame1 day post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    5.25
    (1.97)
    10.05
    (1.86)
    30. Primary Outcome
    TitleHADS Depression
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
    Time Frame6 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.31
    (1.99)
    9.65
    (1.95)
    31. Primary Outcome
    TitleHADS Depression
    DescriptionHospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.48
    (2.04)
    9.06
    (1.97)
    32. Secondary Outcome
    TitleDeath Anxiety Scale
    Description0-15 (higher score more death anxiety)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.71
    (0.72)
    6.83
    (0.69)
    33. Secondary Outcome
    TitleDeath Anxiety Scale
    Description0-15 (higher score more death anxiety)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    6.57
    (0.67)
    7.85
    (0.66)
    34. Secondary Outcome
    TitleDeath Transcendence Scale
    Description0-60 (higher score more death transcendence)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    13.64
    (5.96)
    11.27
    (5.76)
    35. Secondary Outcome
    TitleHopelessness
    Description0-16 (higher score more hopeless)
    Time FrameBaseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    5.71
    (0.76)
    6.73
    (0.74)
    36. Secondary Outcome
    TitleDeath Anxiety Scale
    Description0-15 (higher score more death anxiety)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    9.14
    (0.67)
    8.13
    (0.64)
    37. Secondary Outcome
    TitleDeath Transcendence Scale
    Description0-60 (higher score more death transcendence)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    33.98
    (6.44)
    19.88
    (6.41)
    38. Secondary Outcome
    TitleHopelessness
    Description0-16 (higher score more hopeless)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    2.79
    (0.76)
    6.08
    (0.75)
    39. Secondary Outcome
    TitleHopelessness
    Description0-16 (higher score more hopeless)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    2.30
    (0.82)
    3.86
    (0.82)
    40. Secondary Outcome
    TitleDemoralization Scale
    Description0-96 (higher score more demoralized)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    35.71
    (3.61)
    38.07
    (3.49)
    41. Secondary Outcome
    TitleDemoralization Scale
    Description0-96 (higher score more demoralized)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    18.79
    (3.61)
    32.79
    (3.57)
    42. Secondary Outcome
    TitleDemoralization Scale
    Description0-96 (higher score more demoralized)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    19.38
    (3.93)
    24.58
    (3.92)
    43. Secondary Outcome
    TitleQoL Physical Health Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.14
    (0.94)
    12.53
    (0.91)
    44. Secondary Outcome
    TitleQoL Physical Health Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    16.0
    (0.94)
    12.44
    (0.94)
    45. Secondary Outcome
    TitleQoL Physical Health Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    16.77
    (1.05)
    14.14
    (1.05)
    46. Secondary Outcome
    TitleQoL Psychological Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    13.57
    (.66)
    12.67
    (.64)
    47. Secondary Outcome
    TitleQoL Psychological Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.43
    (.66)
    12.28
    (.66)
    48. Secondary Outcome
    TitleQoL Psychological Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.78
    (.74)
    14.90
    (0.74)
    49. Secondary Outcome
    TitleQoL Social Relationships Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    13.62
    (.85)
    13.24
    (.82)
    50. Secondary Outcome
    TitleQoL Social Relationships Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    14.86
    (.85)
    12.78
    (.85)
    51. Secondary Outcome
    TitleQoL Social Relationships Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.6
    (.95)
    13.71
    (.95)
    52. Secondary Outcome
    TitleQoL Environment Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2-4 weeks prior to drug administration/ Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    15.75
    (.74)
    14.93
    (.71)
    53. Secondary Outcome
    TitleQoL Environment Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame2 weeks post drug administration 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    16.42
    (0.74)
    13.90
    (.74)
    54. Secondary Outcome
    TitleQoL Environment Scale
    Description4-20 (higher score improved quality of life domain)
    Time Frame26 weeks post drug administration 2

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePsilocybin First, Then NiacinNiacin First, Then Psilocybin
    Arm/Group DescriptionDrug intervention 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 250mgActive control 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
    Measure Participants1415
    Mean (Standard Error) [score on a scale]
    16.96
    (.82)
    15.82
    (.82)

    Adverse Events

    Time Frame5 years
    Adverse Event Reporting Description
    Arm/Group TitlePsilocybinNiacin
    Arm/Group DescriptionPsilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mgPsilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
    All Cause Mortality
    PsilocybinNiacin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/29 (0%) 0/29 (0%)
    Serious Adverse Events
    PsilocybinNiacin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/29 (0%) 0/29 (0%)
    Other (Not Including Serious) Adverse Events
    PsilocybinNiacin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/29 (3.4%) 0/29 (0%)
    Blood and lymphatic system disorders
    elevations in BP and HR1/29 (3.4%) 10/29 (0%) 0
    Psychiatric disorders
    Transient Anxiety1/29 (3.4%) 10/29 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleStephen Ross, MD
    OrganizationNYU Langone Health
    Phone212-263-7264
    EmailStephen.Ross@nyulangone.org
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT00957359
    Other Study ID Numbers:
    • 06-954
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Oct 20, 2020
    Last Verified:
    Sep 1, 2020