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Psilocybin Cancer Anxiety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00957359
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : October 3, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Psilocybin
Drug: Niacin
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin Total
Hide 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 Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 14 participants 15 participants 29 participants
52  (15.03) 60.27  (9.45) 56.28  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
7
  50.0%
11
  73.3%
18
  62.1%
Male
7
  50.0%
4
  26.7%
11
  37.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
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%
0
   0.0%
Unknown or Not Reported
1
   7.1%
2
  13.3%
3
  10.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14
 100.0%
15
 100.0%
29
 100.0%
1.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.14  (1.88) 16.93  (1.81)
2.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
9.0  (.83) 9.0  (0.8)
3.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
3.43  (.83) 6.0  (.80)
4.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
4.64  (.83) 8.44  (.82)
5.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
4.57  (0.88) 7.98  (0.83)
6.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
3.60  (.90) 5.54  (.89)
7.Primary Outcome
Title HADS Anxiety
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
2.69  (.92) 4.70  (.89)
8.Primary Outcome
Title State-Trait Anxiety Inventory (STAI) State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
43.79  (2.83) 48.53  (2.12)
9.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
39.07  (2.83) 45.6  (2.73)
10.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
27.5  (2.83) 40.33  (2.73)
11.Primary Outcome
Title HADS Depression
Hide Description 0-21 (higher score more depression)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
5.29  (0.92) 7  (0.89)
12.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
33.5  (2.83) 47.05  (2.80)
13.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
32.72  (2.99) 45.31  (2.82)
14.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
25.73  (3.04) 38.11  (2.83)
15.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
30.67  (3.05) 37.77  (3.07)
16.Primary Outcome
Title STAI State
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
28.04  (3.15) 38.28  (3.04)
17.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
43.79  (2.83) 48.53  (2.12)
18.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
39.07  (2.83) 45.87  (2.12)
19.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
27.5  (2.83) 44  (2.12)
20.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
33.5  (2.83) 46.19  (2.17)
21.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
32.72  (2.99) 45.31  (2.82)
22.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
25.73  (3.04) 38.11  (2.83)
23.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
30.67  (3.05) 37.77  (3.07)
24.Primary Outcome
Title STAI Trait
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
28.04  (3.15) 38.28  (3.04)
25.Primary Outcome
Title HADS Depression
Hide Description 0-21 (higher score more depression)
Time Frame 1 day prior to drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
10.43  (1.88) 16.47  (1.81)
26.Primary Outcome
Title HADS Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
4.21  (1.88) 12.07  (1.81)
27.Primary Outcome
Title HADS Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.5  (1.88) 14.24  (1.84)
28.Primary Outcome
Title HADS Anxiety
Hide Description 0-21 (higher score more anxiety)
Time Frame 1 day post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.84  (0.69) 13.02  (1.85)
29.Primary Outcome
Title HADS Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
5.25  (1.97) 10.05  (1.86)
30.Primary Outcome
Title HADS Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.31  (1.99) 9.65  (1.95)
31.Primary Outcome
Title HADS Depression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.48  (2.04) 9.06  (1.97)
32.Secondary Outcome
Title Death Anxiety Scale
Hide Description 0-15 (higher score more death anxiety)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.71  (0.72) 6.83  (0.69)
33.Secondary Outcome
Title Death Anxiety Scale
Hide Description 0-15 (higher score more death anxiety)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
6.57  (0.67) 7.85  (0.66)
34.Secondary Outcome
Title Death Transcendence Scale
Hide Description 0-60 (higher score more death transcendence)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
13.64  (5.96) 11.27  (5.76)
35.Secondary Outcome
Title Hopelessness
Hide Description 0-16 (higher score more hopeless)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
5.71  (0.76) 6.73  (0.74)
36.Secondary Outcome
Title Death Anxiety Scale
Hide Description 0-15 (higher score more death anxiety)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
9.14  (0.67) 8.13  (0.64)
37.Secondary Outcome
Title Death Transcendence Scale
Hide Description 0-60 (higher score more death transcendence)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
33.98  (6.44) 19.88  (6.41)
38.Secondary Outcome
Title Hopelessness
Hide Description 0-16 (higher score more hopeless)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
2.79  (0.76) 6.08  (0.75)
39.Secondary Outcome
Title Hopelessness
Hide Description 0-16 (higher score more hopeless)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
2.30  (0.82) 3.86  (0.82)
40.Secondary Outcome
Title Demoralization Scale
Hide Description 0-96 (higher score more demoralized)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
35.71  (3.61) 38.07  (3.49)
41.Secondary Outcome
Title Demoralization Scale
Hide Description 0-96 (higher score more demoralized)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
18.79  (3.61) 32.79  (3.57)
42.Secondary Outcome
Title Demoralization Scale
Hide Description 0-96 (higher score more demoralized)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
19.38  (3.93) 24.58  (3.92)
43.Secondary Outcome
Title QoL Physical Health Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.14  (0.94) 12.53  (0.91)
44.Secondary Outcome
Title QoL Physical Health Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
16.0  (0.94) 12.44  (0.94)
45.Secondary Outcome
Title QoL Physical Health Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
16.77  (1.05) 14.14  (1.05)
46.Secondary Outcome
Title QoL Psychological Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
13.57  (.66) 12.67  (.64)
47.Secondary Outcome
Title QoL Psychological Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.43  (.66) 12.28  (.66)
48.Secondary Outcome
Title QoL Psychological Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.78  (.74) 14.90  (0.74)
49.Secondary Outcome
Title QoL Social Relationships Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
13.62  (.85) 13.24  (.82)
50.Secondary Outcome
Title QoL Social Relationships Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2 weeks post drug administration 1
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[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
14.86  (.85) 12.78  (.85)
51.Secondary Outcome
Title QoL Social Relationships Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.6  (.95) 13.71  (.95)
52.Secondary Outcome
Title QoL Environment Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2-4 weeks prior to drug administration/ Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
15.75  (.74) 14.93  (.71)
53.Secondary Outcome
Title QoL Environment Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 2 weeks post drug administration 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
16.42  (0.74) 13.90  (.74)
54.Secondary Outcome
Title QoL Environment Scale
Hide Description 4-20 (higher score improved quality of life domain)
Time Frame 26 weeks post drug administration 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Psilocybin First, Then Niacin Niacin First, Then Psilocybin
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Error)
Unit of Measure: score on a scale
16.96  (.82) 15.82  (.82)
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Psilocybin Niacin
Hide 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 (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/29 (0.00%)    
Hide Serious Adverse Events
Psilocybin Niacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/29 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Psilocybin Niacin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      0/29 (0.00%)    
Blood and lymphatic system disorders     
elevations in BP and HR   1/29 (3.45%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Transient Anxiety   1/29 (3.45%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Ross, MD
Organization: NYU Langone Health
Phone: 212-263-7264
EMail: Stephen.Ross@nyulangone.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00957359    
Other Study ID Numbers: 06-954
First Submitted: August 11, 2009
First Posted: August 12, 2009
Results First Submitted: February 19, 2019
Results First Posted: October 3, 2019
Last Update Posted: October 20, 2020