Psilocybin Cancer Anxiety Study

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

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 Disease	Intervention/Treatment	Phase
Cancer	Drug: Psilocybin; Drug: Niacin	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	NYU College of Dentistry Bluestone Center for Clinical Research	New York	New York	United States	10010

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)

• Study Protocol and Statistical Analysis Plan - Mar 21, 2018

More Information

Additional Information:

• Related Info

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: Cancer; Anxiety; Depression; Hallucinogens
• Additional relevant MeSH terms: Anxiety Disorders; Niacin; Psilocybin; N,N-Dimethyltryptamine

Study Results

Participant Flow

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	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.	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
STARTED	14	15
COMPLETED	14	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin	Total
Arm/Group Description	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	Total of all reporting groups
Overall Participants	14	15	29
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

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	2-4 weeks prior to drug administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.14 (1.88)	16.93 (1.81)

2. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	1 day prior to drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	9.0 (.83)	9.0 (0.8)

3. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	1 day post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	3.43 (.83)	6.0 (.80)

4. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	6 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	4.64 (.83)	8.44 (.82)

5. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	1 day prior to drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	4.57 (0.88)	7.98 (0.83)

6. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	6 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	3.60 (.90)	5.54 (.89)

7. Primary Outcome

Title	HADS Anxiety
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	2.69 (.92)	4.70 (.89)

8. Primary Outcome

Title	State-Trait Anxiety Inventory (STAI) State
Description	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).
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	43.79 (2.83)	48.53 (2.12)

9. Primary Outcome

Title	STAI State
Description	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).
Time Frame	1 day prior to drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	39.07 (2.83)	45.6 (2.73)

10. Primary Outcome

Title	STAI State
Description	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).
Time Frame	1 day post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	27.5 (2.83)	40.33 (2.73)

11. Primary Outcome

Title	HADS Depression
Description	0-21 (higher score more depression)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	5.29 (0.92)	7 (0.89)

12. Primary Outcome

Title	STAI State
Description	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).
Time Frame	6 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	33.5 (2.83)	47.05 (2.80)

13. Primary Outcome

Title	STAI State
Description	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).
Time Frame	1 day prior to drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	32.72 (2.99)	45.31 (2.82)

14. Primary Outcome

Title	STAI State
Description	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).
Time Frame	1 day post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	25.73 (3.04)	38.11 (2.83)

15. Primary Outcome

Title	STAI State
Description	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).
Time Frame	6 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	30.67 (3.05)	37.77 (3.07)

16. Primary Outcome

Title	STAI State
Description	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).
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	28.04 (3.15)	38.28 (3.04)

17. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	43.79 (2.83)	48.53 (2.12)

18. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	1 day prior to drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	39.07 (2.83)	45.87 (2.12)

19. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	1 day post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	27.5 (2.83)	44 (2.12)

20. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	6 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	33.5 (2.83)	46.19 (2.17)

21. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	1 day prior to drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	32.72 (2.99)	45.31 (2.82)

22. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	1 day post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	25.73 (3.04)	38.11 (2.83)

23. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	6 weeks prior to drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	30.67 (3.05)	37.77 (3.07)

24. Primary Outcome

Title	STAI Trait
Description	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).
Time Frame	6 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	28.04 (3.15)	38.28 (3.04)

25. Primary Outcome

Title	HADS Depression
Description	0-21 (higher score more depression)
Time Frame	1 day prior to drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	10.43 (1.88)	16.47 (1.81)

26. Primary Outcome

Title	HADS Depression
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Time Frame	1 day post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	4.21 (1.88)	12.07 (1.81)

27. Primary Outcome

Title	HADS Depression
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Time Frame	6 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.5 (1.88)	14.24 (1.84)

28. Primary Outcome

Title	HADS Anxiety
Description	0-21 (higher score more anxiety)
Time Frame	1 day post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.84 (0.69)	13.02 (1.85)

29. Primary Outcome

Title	HADS Depression
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Time Frame	1 day post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	5.25 (1.97)	10.05 (1.86)

30. Primary Outcome

Title	HADS Depression
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Time Frame	6 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.31 (1.99)	9.65 (1.95)

31. Primary Outcome

Title	HADS Depression
Description	Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.48 (2.04)	9.06 (1.97)

32. Secondary Outcome

Title	Death Anxiety Scale
Description	0-15 (higher score more death anxiety)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.71 (0.72)	6.83 (0.69)

33. Secondary Outcome

Title	Death Anxiety Scale
Description	0-15 (higher score more death anxiety)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	6.57 (0.67)	7.85 (0.66)

34. Secondary Outcome

Title	Death Transcendence Scale
Description	0-60 (higher score more death transcendence)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	13.64 (5.96)	11.27 (5.76)

35. Secondary Outcome

Title	Hopelessness
Description	0-16 (higher score more hopeless)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	5.71 (0.76)	6.73 (0.74)

36. Secondary Outcome

Title	Death Anxiety Scale
Description	0-15 (higher score more death anxiety)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	9.14 (0.67)	8.13 (0.64)

37. Secondary Outcome

Title	Death Transcendence Scale
Description	0-60 (higher score more death transcendence)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	33.98 (6.44)	19.88 (6.41)

38. Secondary Outcome

Title	Hopelessness
Description	0-16 (higher score more hopeless)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	2.79 (0.76)	6.08 (0.75)

39. Secondary Outcome

Title	Hopelessness
Description	0-16 (higher score more hopeless)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	2.30 (0.82)	3.86 (0.82)

40. Secondary Outcome

Title	Demoralization Scale
Description	0-96 (higher score more demoralized)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	35.71 (3.61)	38.07 (3.49)

41. Secondary Outcome

Title	Demoralization Scale
Description	0-96 (higher score more demoralized)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	18.79 (3.61)	32.79 (3.57)

42. Secondary Outcome

Title	Demoralization Scale
Description	0-96 (higher score more demoralized)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	19.38 (3.93)	24.58 (3.92)

43. Secondary Outcome

Title	QoL Physical Health Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.14 (0.94)	12.53 (0.91)

44. Secondary Outcome

Title	QoL Physical Health Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	16.0 (0.94)	12.44 (0.94)

45. Secondary Outcome

Title	QoL Physical Health Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	16.77 (1.05)	14.14 (1.05)

46. Secondary Outcome

Title	QoL Psychological Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	13.57 (.66)	12.67 (.64)

47. Secondary Outcome

Title	QoL Psychological Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.43 (.66)	12.28 (.66)

48. Secondary Outcome

Title	QoL Psychological Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.78 (.74)	14.90 (0.74)

49. Secondary Outcome

Title	QoL Social Relationships Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	13.62 (.85)	13.24 (.82)

50. Secondary Outcome

Title	QoL Social Relationships Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	14.86 (.85)	12.78 (.85)

51. Secondary Outcome

Title	QoL Social Relationships Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.6 (.95)	13.71 (.95)

52. Secondary Outcome

Title	QoL Environment Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2-4 weeks prior to drug administration/ Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	15.75 (.74)	14.93 (.71)

53. Secondary Outcome

Title	QoL Environment Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	2 weeks post drug administration 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	16.42 (0.74)	13.90 (.74)

54. Secondary Outcome

Title	QoL Environment Scale
Description	4-20 (higher score improved quality of life domain)
Time Frame	26 weeks post drug administration 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psilocybin First, Then Niacin	Niacin First, Then Psilocybin
Arm/Group Description	Drug 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 250mg	Active 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 Participants	14	15
Mean (Standard Error) [score on a scale]	16.96 (.82)	15.82 (.82)

Adverse Events

Time Frame	5 years
Arm/Group Title	Psilocybin		Niacin
Arm/Group Description	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		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
All Cause Mortality
	Psilocybin		Niacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Psilocybin		Niacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Psilocybin		Niacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)		0/29 (0%)
Blood and lymphatic system disorders
elevations in BP and HR	1/29 (3.4%)	1	0/29 (0%)	0
Psychiatric disorders
Transient Anxiety	1/29 (3.4%)	1	0/29 (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.