Trial Outcomes & Findings for A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence (NCT NCT02061293)
NCT ID: NCT02061293
Last Updated: 2022-11-08
Results Overview
The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Screening (Week 0)
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Psilocybin
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Psilocybin
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Diphenhydramine
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
46
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Psilocybin
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Psilocybin
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Diphenhydramine
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Overall Study
Elevated Blood Pressure
|
1
|
1
|
Baseline Characteristics
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.94 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
44.24 years
STANDARD_DEVIATION 12.15 • n=7 Participants
|
45.59 years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening (Week 0)The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
56.48 percentage of days
Standard Deviation 31.77
|
48.57 percentage of days
Standard Deviation 28.73
|
PRIMARY outcome
Timeframe: Baseline (Week 4)The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
24.11 percentage of days
Standard Deviation 26.29
|
21.31 percentage of days
Standard Deviation 20.14
|
PRIMARY outcome
Timeframe: Follow Up (Weeks 5-36)The Timeline Follow-back (TLFB) method is used to calculate the percent of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Heavy Drinking Days
|
9.71 percentage of days
Standard Deviation 26.21
|
23.57 percentage of days
Standard Deviation 26.67
|
PRIMARY outcome
Timeframe: Screening (Week 0)The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Drinks Per Day
|
5.2 drinks per day
Standard Deviation 2.81
|
4.38 drinks per day
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: Baseline (Week 4)The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Drinks Per Day
|
2.77 drinks per day
Standard Deviation 2.3
|
2.19 drinks per day
Standard Deviation 1.98
|
PRIMARY outcome
Timeframe: Follow Up (Weeks 5-36)The Timeline Follow-back (TLFB) method is used to calculate drinks per day. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Drinks Per Day
|
1.17 drinks per day
Standard Deviation 1.99
|
2.26 drinks per day
Standard Deviation 2.02
|
PRIMARY outcome
Timeframe: Screening (Week 0)The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Drinking Days
|
78.03 percentage of days
Standard Deviation 27.02
|
71.68 percentage of days
Standard Deviation 28.98
|
PRIMARY outcome
Timeframe: Baseline (Week 4)The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Drinking Days
|
52.98 percentage of days
Standard Deviation 31.78
|
45.99 percentage of days
Standard Deviation 30.4
|
PRIMARY outcome
Timeframe: Follow Up (Weeks 5-36)The Timeline Follow-back (TLFB) method is used to calculate the percentage of days that participants drank alcohol. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Drinking Days
|
29.39 percentage of days
Standard Deviation 32.86
|
42.83 percentage of days
Standard Deviation 33.43
|
SECONDARY outcome
Timeframe: Baseline (Week 4)15-item self-report questionnaire assessing problems related to alcohol use. Items are ranked on a 4-point Likert scale ranging from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use.
Outcome measures
| Measure |
Psilocybin
n=47 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Short Inventory of Problems (SIP-2R) Score
|
20.26 score on a scale
Standard Deviation 8.89
|
21.6 score on a scale
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: Week 3615-item self-report questionnaire assessing problems related to alcohol use. Items are ranked on a 4-point Likert scale ranging from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use.
Outcome measures
| Measure |
Psilocybin
n=44 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=40 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Short Inventory of Problems (SIP-2R) Score
|
6.59 score on a scale
Standard Deviation 8.8
|
13 score on a scale
Standard Deviation 10.48
|
SECONDARY outcome
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36The Timeline Follow-back (TLFB) method is used in calculating abstinence from drinking. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Abstinence is defined as zero drinks of alcohol over the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percentage of Participants Achieving Abstinence From Drinking
|
22.9 Percentage of participants
|
8.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 33 up to Week 36The Timeline Follow-back (TLFB) method is used in calculating abstinence from drinking. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Abstinence is defined as zero drinks of alcohol over the target period.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percentage of Participants Achieving Abstinence From Drinking
|
47.9 Percentage of participants
|
24.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36The Timeline Follow-back (TLFB) method is used in calculating the number of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving No Heavy Drinking Days
|
33.3 Percentage of participants
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 33 Up to Week 36The Timeline Follow-back (TLFB) method is used in calculating the number of heavy drinking days. The TLFB is a method for assessing the number of drinks of alcohol on a daily basis over the previous 30 days. For each day in the recall period, the participant indicates the number of drinks of alcohol they consumed. The TLFB provides a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving No Heavy Drinking Days
|
62.5 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level
|
83.3 Percentage of participants
|
71.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 33 Up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 1 Level
|
89.6 Percentage of participants
|
64.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels
|
60.4 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 33 Up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 2 Levels
|
60.4 Percentage of participants
|
40 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 5 (1 week after first drug administration) up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels
|
29.92 Percentage of participants
|
13.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Week 33 up to Week 36For men, WHO low risk drinking (level 1) is defined as \>0 grams of alcohol/day (g/d) to 40 g/d; moderate risk (level 2) as \>40 g/d to 60 g/d; high risk (level 3) as \>60 g/d to 100 g/d; and very high risk (level 4) as \>100 g/d. For women, low risk (level 1) is defined as \>0 g/d to 20 g/d; moderate risk (level 2) as \>20 g/d to 40 g/d; high risk (level 3) as \>40 g/d to 60 g/d; and very high risk (level 4) as \>60 g/d. Abstinence was defined as no risk (level 0).
Outcome measures
| Measure |
Psilocybin
n=48 Participants
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 Participants
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Percent of Participants Achieving WHO Risk Drinking Level Decrease of at Least 3 Levels
|
37.5 Percentage of participants
|
17.8 Percentage of participants
|
Adverse Events
Psilocybin
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Diphenhydramine
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Psilocybin
n=48 participants at risk
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 participants at risk
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Gastrointestinal disorders
Mallory-Weiss Syndrom
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
Other adverse events
| Measure |
Psilocybin
n=48 participants at risk
Psilocybin 25 mg/70 kg PO administered at week 4, 25-40 mg/70 kg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
Diphenhydramine
n=45 participants at risk
Diphenhydramine 50 mg PO administered at week 4, 50-100 mg PO administered at week 8.
Motivational Enhancement and Taking Action (META): Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Cardiac disorders
Palpitations
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Eye disorders
Cataract
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Eye disorders
Photopsia
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Diverticulitis
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Food poisoning
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Nausea
|
20.8%
10/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
8.9%
4/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Toothache
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Asthenia
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Fatigue
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Influenza like Illness
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Oedema
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
6.7%
3/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Peripheral swelling
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
General disorders
Pyrexia
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Immune system disorders
Dermatitis contact
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Immune system disorders
Food allergy
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
6.7%
3/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Corona virus infection
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Eye infection
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Gingivitis
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Influenza
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Pneumonia
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Infections and infestations
Viral upper resp. tract infection
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
6.7%
3/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Investigations
Biopsy cervix
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Investigations
Blood pressure diastolic increased
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Investigations
Blood pressure increased
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
6.7%
3/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Dizziness
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Headache
|
43.8%
21/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Migraine
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Sedation
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Anger
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Anxiety
|
14.6%
7/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Depressed mood
|
6.2%
3/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Depression
|
4.2%
2/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Dysphoria
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Illusion
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Insomnia
|
6.2%
3/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Psychiatric disorders
Suicidal Ideation
|
8.3%
4/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Reproductive system and breast disorders
Testicular pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lower resp. tract congestion
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
4.4%
2/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Social circumstances
Sexual abuse
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Surgical and medical procedures
Arthoscopic surgery
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
2.2%
1/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
|
Surgical and medical procedures
Skin cosmetic procedure
|
2.1%
1/48 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
0.00%
0/45 • After first medication administration (week 4) through week 36.
Study team / PI monitor AEs at every assessment visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place