Trial Outcomes & Findings for Psilocybin Cancer Anxiety Study (NCT NCT00957359)
NCT ID: NCT00957359
Last Updated: 2020-10-20
Results Overview
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
29 participants
Primary outcome timeframe
2-4 weeks prior to drug administration
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
Psilocybin First, Then Niacin
Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg.
|
Niacin First, Then Psilocybin
Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psilocybin Cancer Anxiety Study
Baseline characteristics by cohort
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
Psilocybin: Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
|
Niacin First, Then Psilocybin
n=15 Participants
Niacin: Psilocybin 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
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
52 Years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
60.27 Years
STANDARD_DEVIATION 9.45 • n=7 Participants
|
56.28 Years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-4 weeks prior to drug administrationHospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
15.14 score on a scale
Standard Error 1.88
|
16.93 score on a scale
Standard Error 1.81
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 1Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
9.0 score on a scale
Standard Error .83
|
9.0 score on a scale
Standard Error 0.8
|
PRIMARY outcome
Timeframe: 1 day post drug administration 1Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
3.43 score on a scale
Standard Error .83
|
6.0 score on a scale
Standard Error .80
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 1Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
4.64 score on a scale
Standard Error .83
|
8.44 score on a scale
Standard Error .82
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
4.57 score on a scale
Standard Error 0.88
|
7.98 score on a scale
Standard Error 0.83
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
3.60 score on a scale
Standard Error .90
|
5.54 score on a scale
Standard Error .89
|
PRIMARY outcome
Timeframe: 26 weeks post drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
2.69 score on a scale
Standard Error .92
|
4.70 score on a scale
Standard Error .89
|
PRIMARY outcome
Timeframe: 2-4 weeks prior to drug administration/ BaselineSTAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
State-Trait Anxiety Inventory (STAI) State
|
43.79 score on a scale
Standard Error 2.83
|
48.53 score on a scale
Standard Error 2.12
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
39.07 score on a scale
Standard Error 2.83
|
45.6 score on a scale
Standard Error 2.73
|
PRIMARY outcome
Timeframe: 1 day post drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
27.5 score on a scale
Standard Error 2.83
|
40.33 score on a scale
Standard Error 2.73
|
PRIMARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
5.29 score on a scale
Standard Error 0.92
|
7 score on a scale
Standard Error 0.89
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
33.5 score on a scale
Standard Error 2.83
|
47.05 score on a scale
Standard Error 2.80
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
32.72 score on a scale
Standard Error 2.99
|
45.31 score on a scale
Standard Error 2.82
|
PRIMARY outcome
Timeframe: 1 day post drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
25.73 score on a scale
Standard Error 3.04
|
38.11 score on a scale
Standard Error 2.83
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
30.67 score on a scale
Standard Error 3.05
|
37.77 score on a scale
Standard Error 3.07
|
PRIMARY outcome
Timeframe: 26 weeks post drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI State
|
28.04 score on a scale
Standard Error 3.15
|
38.28 score on a scale
Standard Error 3.04
|
PRIMARY outcome
Timeframe: 2-4 weeks prior to drug administration/ BaselineSTAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
43.79 score on a scale
Standard Error 2.83
|
48.53 score on a scale
Standard Error 2.12
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
39.07 score on a scale
Standard Error 2.83
|
45.87 score on a scale
Standard Error 2.12
|
PRIMARY outcome
Timeframe: 1 day post drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
27.5 score on a scale
Standard Error 2.83
|
44 score on a scale
Standard Error 2.12
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 1STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
33.5 score on a scale
Standard Error 2.83
|
46.19 score on a scale
Standard Error 2.17
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
32.72 score on a scale
Standard Error 2.99
|
45.31 score on a scale
Standard Error 2.82
|
PRIMARY outcome
Timeframe: 1 day post drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
25.73 score on a scale
Standard Error 3.04
|
38.11 score on a scale
Standard Error 2.83
|
PRIMARY outcome
Timeframe: 6 weeks prior to drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
30.67 score on a scale
Standard Error 3.05
|
37.77 score on a scale
Standard Error 3.07
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 2STAI 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).
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
STAI Trait
|
28.04 score on a scale
Standard Error 3.15
|
38.28 score on a scale
Standard Error 3.04
|
PRIMARY outcome
Timeframe: 1 day prior to drug administration 10-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
10.43 score on a scale
Standard Error 1.88
|
16.47 score on a scale
Standard Error 1.81
|
PRIMARY outcome
Timeframe: 1 day post drug administration 1Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
4.21 score on a scale
Standard Error 1.88
|
12.07 score on a scale
Standard Error 1.81
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 1Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
6.5 score on a scale
Standard Error 1.88
|
14.24 score on a scale
Standard Error 1.84
|
PRIMARY outcome
Timeframe: 1 day post drug administration 20-21 (higher score more anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Anxiety
|
6.84 score on a scale
Standard Error 0.69
|
13.02 score on a scale
Standard Error 1.85
|
PRIMARY outcome
Timeframe: 1 day post drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
5.25 score on a scale
Standard Error 1.97
|
10.05 score on a scale
Standard Error 1.86
|
PRIMARY outcome
Timeframe: 6 weeks post drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
6.31 score on a scale
Standard Error 1.99
|
9.65 score on a scale
Standard Error 1.95
|
PRIMARY outcome
Timeframe: 26 weeks post drug administration 2Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
HADS Depression
|
6.48 score on a scale
Standard Error 2.04
|
9.06 score on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 20-15 (higher score more death anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Death Anxiety Scale
|
6.71 score on a scale
Standard Error 0.72
|
6.83 score on a scale
Standard Error 0.69
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 10-15 (higher score more death anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Death Anxiety Scale
|
6.57 score on a scale
Standard Error 0.67
|
7.85 score on a scale
Standard Error 0.66
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline0-60 (higher score more death transcendence)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Death Transcendence Scale
|
13.64 score on a scale
Standard Error 5.96
|
11.27 score on a scale
Standard Error 5.76
|
SECONDARY outcome
Timeframe: Baseline0-16 (higher score more hopeless)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Hopelessness
|
5.71 score on a scale
Standard Error 0.76
|
6.73 score on a scale
Standard Error 0.74
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline0-15 (higher score more death anxiety)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Death Anxiety Scale
|
9.14 score on a scale
Standard Error 0.67
|
8.13 score on a scale
Standard Error 0.64
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 10-60 (higher score more death transcendence)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Death Transcendence Scale
|
33.98 score on a scale
Standard Error 6.44
|
19.88 score on a scale
Standard Error 6.41
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 10-16 (higher score more hopeless)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Hopelessness
|
2.79 score on a scale
Standard Error 0.76
|
6.08 score on a scale
Standard Error 0.75
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 20-16 (higher score more hopeless)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Hopelessness
|
2.30 score on a scale
Standard Error 0.82
|
3.86 score on a scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline0-96 (higher score more demoralized)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Demoralization Scale
|
35.71 score on a scale
Standard Error 3.61
|
38.07 score on a scale
Standard Error 3.49
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 10-96 (higher score more demoralized)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Demoralization Scale
|
18.79 score on a scale
Standard Error 3.61
|
32.79 score on a scale
Standard Error 3.57
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 20-96 (higher score more demoralized)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
Demoralization Scale
|
19.38 score on a scale
Standard Error 3.93
|
24.58 score on a scale
Standard Error 3.92
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline4-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Physical Health Scale
|
15.14 score on a scale
Standard Error 0.94
|
12.53 score on a scale
Standard Error 0.91
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 14-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Physical Health Scale
|
16.0 score on a scale
Standard Error 0.94
|
12.44 score on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 24-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Physical Health Scale
|
16.77 score on a scale
Standard Error 1.05
|
14.14 score on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline4-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Psychological Scale
|
13.57 score on a scale
Standard Error .66
|
12.67 score on a scale
Standard Error .64
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 14-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Psychological Scale
|
15.43 score on a scale
Standard Error .66
|
12.28 score on a scale
Standard Error .66
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 24-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Psychological Scale
|
15.78 score on a scale
Standard Error .74
|
14.90 score on a scale
Standard Error 0.74
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline4-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Social Relationships Scale
|
13.62 score on a scale
Standard Error .85
|
13.24 score on a scale
Standard Error .82
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 14-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Social Relationships Scale
|
14.86 score on a scale
Standard Error .85
|
12.78 score on a scale
Standard Error .85
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 24-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Social Relationships Scale
|
15.6 score on a scale
Standard Error .95
|
13.71 score on a scale
Standard Error .95
|
SECONDARY outcome
Timeframe: 2-4 weeks prior to drug administration/ Baseline4-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Environment Scale
|
15.75 score on a scale
Standard Error .74
|
14.93 score on a scale
Standard Error .71
|
SECONDARY outcome
Timeframe: 2 weeks post drug administration 14-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Environment Scale
|
16.42 score on a scale
Standard Error 0.74
|
13.90 score on a scale
Standard Error .74
|
SECONDARY outcome
Timeframe: 26 weeks post drug administration 24-20 (higher score improved quality of life domain)
Outcome measures
| Measure |
Psilocybin First, Then Niacin
n=14 Participants
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
|
Niacin First, Then Psilocybin
n=15 Participants
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
|
|---|---|---|
|
QoL Environment Scale
|
16.96 score on a scale
Standard Error .82
|
15.82 score on a scale
Standard Error .82
|
Adverse Events
Psilocybin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Niacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psilocybin
n=29 participants at risk
Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
|
Niacin
n=29 participants at risk
Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
|
|---|---|---|
|
Psychiatric disorders
Transient Anxiety
|
3.4%
1/29 • Number of events 1 • 5 years
|
0.00%
0/29 • 5 years
|
|
Blood and lymphatic system disorders
elevations in BP and HR
|
3.4%
1/29 • Number of events 1 • 5 years
|
0.00%
0/29 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place