Trial Outcomes & Findings for Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers (NCT NCT04596267)
NCT ID: NCT04596267
Last Updated: 2023-12-04
Results Overview
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.
TERMINATED
PHASE1
9 participants
2.6 hours
2023-12-04
Participant Flow
A.total of 9 subjects were enrolled and 7 completed the study.
Participant milestones
| Measure |
Pitolisant Then Placebo
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial and 12 days of matched placebo before the second alcohol self-administration trial.
|
Placebo Then Pitolisant
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial and a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the second alcohol self-administration trial.
|
|---|---|---|
|
Medication Dispense/Exposure Period 1
STARTED
|
4
|
5
|
|
Medication Dispense/Exposure Period 1
COMPLETED
|
3
|
4
|
|
Medication Dispense/Exposure Period 1
NOT COMPLETED
|
1
|
1
|
|
Alcohol Self-Administration Trial 1
STARTED
|
3
|
4
|
|
Alcohol Self-Administration Trial 1
COMPLETED
|
3
|
4
|
|
Alcohol Self-Administration Trial 1
NOT COMPLETED
|
0
|
0
|
|
Medication Dispense/Exposure Period 2
STARTED
|
3
|
4
|
|
Medication Dispense/Exposure Period 2
COMPLETED
|
3
|
4
|
|
Medication Dispense/Exposure Period 2
NOT COMPLETED
|
0
|
0
|
|
Alcohol Self-Administration Trial 2
STARTED
|
3
|
4
|
|
Alcohol Self-Administration Trial 2
COMPLETED
|
3
|
4
|
|
Alcohol Self-Administration Trial 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pitolisant Then Placebo
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial and 12 days of matched placebo before the second alcohol self-administration trial.
|
Placebo Then Pitolisant
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial and a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the second alcohol self-administration trial.
|
|---|---|---|
|
Medication Dispense/Exposure Period 1
Lost to Follow-up
|
1
|
0
|
|
Medication Dispense/Exposure Period 1
Physician Decision
|
0
|
1
|
Baseline Characteristics
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
Baseline characteristics by cohort
| Measure |
Placebo Then Pitolisant
n=5 Participants
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial and a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the second alcohol self-administration trial.
|
Total
n=9 Participants
Total of all reporting groups
|
Pitolisant Then Placebo
n=4 Participants
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial and 12 days of matched placebo before the second alcohol self-administration trial.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
30.9 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
28 years
STANDARD_DEVIATION 6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2.6 hoursPopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption in Alcohol Self-Administration Trials
|
67.214 Total SDUs
Standard Deviation 25.759
|
66.786 Total SDUs
Standard Deviation 15.369
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Observation Period, Minute 10
|
0.034 Grams of alcohol/210 Liters of breath
Standard Deviation 0.005
|
0.033 Grams of alcohol/210 Liters of breath
Standard Deviation 0.010
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Observation Period, Minute 20
|
0.038 Grams of alcohol/210 Liters of breath
Standard Deviation 0.009
|
0.0364 Grams of alcohol/210 Liters of breath
Standard Deviation 0.011
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Observation Period, Minute 30
|
0.037 Grams of alcohol/210 Liters of breath
Standard Deviation 0.003
|
0.034 Grams of alcohol/210 Liters of breath
Standard Deviation 0.009
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Observation Period, Minute 40
|
0.033 Grams of alcohol/210 Liters of breath
Standard Deviation 0.006
|
0.031 Grams of alcohol/210 Liters of breath
Standard Deviation 0.006
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Self-administration Block 1, Minute 30
|
0.069 Grams of alcohol/210 Liters of breath
Standard Deviation 0.046
|
0.063 Grams of alcohol/210 Liters of breath
Standard Deviation 0.033
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Self-administration Block 1, Minute 60
|
0.072 Grams of alcohol/210 Liters of breath
Standard Deviation 0.037
|
0.047 Grams of alcohol/210 Liters of breath
Standard Deviation 0.021
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Self-administration Block 2, Minute 30
|
0.086 Grams of alcohol/210 Liters of breath
Standard Deviation 0.040
|
0.075 Grams of alcohol/210 Liters of breath
Standard Deviation 0.046
|
PRIMARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption (BAC): Self-administration Block 2, Minute 60
|
0.079 Grams of alcohol/210 Liters of breath
Standard Deviation 0.047
|
0.082 Grams of alcohol/210 Liters of breath
Standard Deviation 0.056
|
SECONDARY outcome
Timeframe: 12 daysPopulation: A total of 9 subjects were randomized and 7 completed.
The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication exposure period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. Higher VAS scores are associated with more cravings. Lower VAS scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving During 12-day Drug Exposure
|
53.2 score on a scale
Standard Deviation 30.1
|
47.2 score on a scale
Standard Deviation 33.7
|
SECONDARY outcome
Timeframe: 12 daysPopulation: 19 subjects were consented but 10 dropped out prior to randomization in the study (ineligible after screening or lost to follow-up). A total of 9 subjects were randomized and 7 completed.
Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Consumption During the 12-day Drug Exposure
|
67.2 SDUs
Standard Deviation 25.8
|
66.8 SDUs
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher BAES scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Observation Period, Minute 10
|
31.714 score on a scale
Standard Deviation 20.878
|
30.714 score on a scale
Standard Deviation 12.433
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Observation Period, Minute 20
|
31.429 score on a scale
Standard Deviation 19.957
|
30.714 score on a scale
Standard Deviation 12.433
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Observation Period, Minute 30
|
29.571 score on a scale
Standard Deviation 18.183
|
31.857 score on a scale
Standard Deviation 13.322
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Observation Period, Minute 40
|
29.714 score on a scale
Standard Deviation 17.557
|
31.000 score on a scale
Standard Deviation 14.944
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30
|
32.143 score on a scale
Standard Deviation 19.463
|
32.000 score on a scale
Standard Deviation 11.719
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60
|
31.571 score on a scale
Standard Deviation 18.831
|
34.429 score on a scale
Standard Deviation 14.954
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30
|
31.286 score on a scale
Standard Deviation 17.792
|
33.714 score on a scale
Standard Deviation 15.348
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60
|
28.714 score on a scale
Standard Deviation 16.680
|
32.714 score on a scale
Standard Deviation 16.007
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Observation Period, Minute 10
|
12.714 score on a scale
Standard Deviation 8.920
|
18.857 score on a scale
Standard Deviation 15.742
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Observation Period, Minute 20
|
9.429 score on a scale
Standard Deviation 5.827
|
18.286 score on a scale
Standard Deviation 14.407
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Observation Period, Minute 30
|
7.286 score on a scale
Standard Deviation 5.407
|
18.286 score on a scale
Standard Deviation 17.114
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Observation Period, Minute 40
|
8.571 score on a scale
Standard Deviation 7.300
|
18.286 score on a scale
Standard Deviation 17.026
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Self-Administration Block 1, Minute 30
|
9.714 score on a scale
Standard Deviation 7.041
|
20.714 score on a scale
Standard Deviation 18.848
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Self-administration Block 1, Minute 60
|
10.286 score on a scale
Standard Deviation 8.440
|
18.143 score on a scale
Standard Deviation 18.614
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Self-administration Block 2, Minute 30
|
11.286 score on a scale
Standard Deviation 10.323
|
17.571 score on a scale
Standard Deviation 18.537
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol-induced Sedation: Self-administration Block 2, Minute 60
|
9.571 score on a scale
Standard Deviation 14.316
|
16.286 score on a scale
Standard Deviation 19.914
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Urge: Self-administration Block 1, Minute 30
|
26.57 score on a scale
Standard Deviation 10.937
|
24.00 score on a scale
Standard Deviation 3.964
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Urge: Self-administration Block 1, Minute 60
|
23.43 score on a scale
Standard Deviation 11.674
|
27.14 score on a scale
Standard Deviation 11.466
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Urge: Self-administration Block 2, Minute 30
|
21.29 score on a scale
Standard Deviation 13.048
|
23.29 score on a scale
Standard Deviation 12.079
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=4 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Urge: Self-administration Block 2, Minute 60
|
22.00 score on a scale
Standard Deviation 12.055
|
22.43 score on a scale
Standard Deviation 11.731
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Observation Period, Minute 10
|
44.57 score on a scale
Standard Deviation 22.970
|
34.71 score on a scale
Standard Deviation 21.623
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Observation Period, Minute 20
|
44.43 score on a scale
Standard Deviation 31.405
|
37.14 score on a scale
Standard Deviation 23.398
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Observation Period, Minute 30
|
47.29 score on a scale
Standard Deviation 26.266
|
39.57 score on a scale
Standard Deviation 26.038
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Observation Period, Minute 40
|
50.57 score on a scale
Standard Deviation 29.051
|
34.86 score on a scale
Standard Deviation 25.016
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Self-administration Block 1, Minute 30
|
41.29 score on a scale
Standard Deviation 24.965
|
39.86 score on a scale
Standard Deviation 28.962
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Self-administration Block 1, Minute 60
|
42.14 score on a scale
Standard Deviation 27.492
|
40.86 score on a scale
Standard Deviation 31.519
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Self-administration Block 2, Minute 30
|
35.00 score on a scale
Standard Deviation 33.650
|
45.57 score on a scale
Standard Deviation 31.133
|
SECONDARY outcome
Timeframe: 1 minutePopulation: A total of 9 subjects were randomized and 7 completed.
Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.
Outcome measures
| Measure |
Pitolisant
n=7 Participants
Subjects received 12 days of Pitolisant before the alcohol self-administration trial.
|
Placebo
n=7 Participants
Subjects received 12 days of placebo before the alcohol self-administration trial.
|
|---|---|---|
|
Alcohol Craving: Self-administration Block 2, Minute 60
|
41.14 score on a scale
Standard Deviation 35.315
|
42.43 score on a scale
Standard Deviation 29.860
|
Adverse Events
Pitolisant
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pitolisant
n=7 participants at risk
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial.
|
Placebo
n=7 participants at risk
This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial.
|
|---|---|---|
|
Renal and urinary disorders
Bright yellow urine
|
28.6%
2/7 • Number of events 2 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
28.6%
2/7 • Number of events 2 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
0.00%
0/7 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
|
General disorders
Increased Thirst
|
14.3%
1/7 • Number of events 1 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
0.00%
0/7 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
|
General disorders
Left Ankle Pain
|
14.3%
1/7 • Number of events 1 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
0.00%
0/7 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
|
General disorders
Right knee contusion with abrasion
|
14.3%
1/7 • Number of events 1 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
0.00%
0/7 • Up to 48 Days
The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place