Trial Outcomes & Findings for Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism (NCT NCT00612352)
NCT ID: NCT00612352
Last Updated: 2021-10-26
Results Overview
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
COMPLETED
NA
180 participants
Baseline
2021-10-26
Participant Flow
Participant milestones
| Measure |
Family History Positive
Subjects with a positive family history of alcoholism.
|
Family History Negative
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
115
|
|
Overall Study
40%mg & 100%mg
|
1
|
1
|
|
Overall Study
Placebo & 100%mg
|
1
|
0
|
|
Overall Study
100%mg
|
2
|
1
|
|
Overall Study
40%mg
|
1
|
0
|
|
Overall Study
Placebo
|
4
|
4
|
|
Overall Study
COMPLETED
|
56
|
109
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Family History Positive
Subjects with a positive family history of alcoholism.
|
Family History Negative
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
moved out of state
|
1
|
0
|
|
Overall Study
didn't return calls/show up on test date
|
4
|
1
|
Baseline Characteristics
Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism
Baseline characteristics by cohort
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.06 years
STANDARD_DEVIATION 2.97 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 2.38 • n=7 Participants
|
24.08 years
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
139 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
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at Baseline
Placebo
|
0 drinks felt consumed
Standard Deviation 0
|
0 drinks felt consumed
Standard Deviation 0
|
|
Number of Drinks Felt Consumed at Baseline
Alcohol 40mg%
|
0 drinks felt consumed
Standard Deviation 0
|
0 drinks felt consumed
Standard Deviation 0
|
|
Number of Drinks Felt Consumed at Baseline
Alcohol 100mg%
|
0 drinks felt consumed
Standard Deviation 0
|
0.04 drinks felt consumed
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 10 Minutes
Placebo
|
0.07 drinks felt consumed
Standard Deviation 0.42
|
0.08 drinks felt consumed
Standard Deviation 0.37
|
|
Number of Drinks Felt Consumed at 10 Minutes
Alcohol 40mg%
|
0.49 drinks felt consumed
Standard Deviation 0.8
|
0.7 drinks felt consumed
Standard Deviation 0.92
|
|
Number of Drinks Felt Consumed at 10 Minutes
Alcohol 100mg%
|
0.76 drinks felt consumed
Standard Deviation 1.07
|
1.15 drinks felt consumed
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 30 Minutes
Placebo
|
0.2 drinks felt consumed
Standard Deviation 0.5
|
0.27 drinks felt consumed
Standard Deviation 0.67
|
|
Number of Drinks Felt Consumed at 30 Minutes
Alcohol 40mg%
|
1.88 drinks felt consumed
Standard Deviation 1.11
|
2.03 drinks felt consumed
Standard Deviation 1.68
|
|
Number of Drinks Felt Consumed at 30 Minutes
Alcohol 100mg%
|
3.65 drinks felt consumed
Standard Deviation 1.61
|
3.86 drinks felt consumed
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 110 Minutes
Placebo
|
0.1 drinks felt consumed
Standard Deviation 0.4
|
0.09 drinks felt consumed
Standard Deviation 0.4
|
|
Number of Drinks Felt Consumed at 110 Minutes
Alcohol 40mg%
|
0.97 drinks felt consumed
Standard Deviation 0.97
|
1.2 drinks felt consumed
Standard Deviation 1.39
|
|
Number of Drinks Felt Consumed at 110 Minutes
Alcohol 100mg%
|
3.22 drinks felt consumed
Standard Deviation 1.61
|
3.64 drinks felt consumed
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 140 Minutes
Placebo
|
0.03 drinks felt consumed
Standard Deviation 0.18
|
0.04 drinks felt consumed
Standard Deviation 0.23
|
|
Number of Drinks Felt Consumed at 140 Minutes
Alcohol 40mg%
|
0.33 drinks felt consumed
Standard Deviation 0.63
|
0.46 drinks felt consumed
Standard Deviation 0.88
|
|
Number of Drinks Felt Consumed at 140 Minutes
Alcohol 100mg%
|
2.12 drinks felt consumed
Standard Deviation 1.79
|
2.53 drinks felt consumed
Standard Deviation 2.78
|
PRIMARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 170 Minutes
Placebo
|
0 drinks felt consumed
Standard Deviation 0
|
0 drinks felt consumed
Standard Deviation 0
|
|
Number of Drinks Felt Consumed at 170 Minutes
Alcohol 40mg%
|
0.07 drinks felt consumed
Standard Deviation 0.32
|
0.11 drinks felt consumed
Standard Deviation 0.39
|
|
Number of Drinks Felt Consumed at 170 Minutes
Alcohol 100mg%
|
1.19 drinks felt consumed
Standard Deviation 1.5
|
1.39 drinks felt consumed
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: 230 minutesPopulation: All available data was utilized in the analysis using mixed models.
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 230 Minutes
Placebo
|
0 drinks felt consumed
Standard Deviation 0
|
0 drinks felt consumed
Standard Deviation 0
|
|
Number of Drinks Felt Consumed at 230 Minutes
Alcohol 40mg%
|
0.03 drinks felt consumed
Standard Deviation 0.26
|
0.03 drinks felt consumed
Standard Deviation 0.21
|
|
Number of Drinks Felt Consumed at 230 Minutes
Alcohol 100mg%
|
0.37 drinks felt consumed
Standard Deviation 0.79
|
0.55 drinks felt consumed
Standard Deviation 1.16
|
PRIMARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - Baseline
Placebo
|
0.08 units on a scale
Standard Deviation 0.64
|
0.13 units on a scale
Standard Deviation 0.65
|
|
Visual Analog Scale of Similarity to Alcohol - Baseline
Alcohol 40mg%
|
0.1 units on a scale
Standard Deviation 0.41
|
0.1 units on a scale
Standard Deviation 0.62
|
|
Visual Analog Scale of Similarity to Alcohol - Baseline
Alcohol 100mg%
|
0.02 units on a scale
Standard Deviation 0.13
|
0.1 units on a scale
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol -10 Minutes
Placebo
|
0.16 units on a scale
Standard Deviation 0.73
|
0.12 units on a scale
Standard Deviation 0.41
|
|
Visual Analog Scale of Similarity to Alcohol -10 Minutes
Alcohol 40mg%
|
0.76 units on a scale
Standard Deviation 1.3
|
1.13 units on a scale
Standard Deviation 1.6
|
|
Visual Analog Scale of Similarity to Alcohol -10 Minutes
Alcohol 100mg%
|
1.59 units on a scale
Standard Deviation 2.2
|
1.56 units on a scale
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Placebo
|
0.36 units on a scale
Standard Deviation 1.08
|
0.33 units on a scale
Standard Deviation 0.69
|
|
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Alcohol 40mg%
|
2.05 units on a scale
Standard Deviation 2.06
|
2.62 units on a scale
Standard Deviation 2.25
|
|
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Alcohol 100mg%
|
3.82 units on a scale
Standard Deviation 2.05
|
3.98 units on a scale
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Placebo
|
0.36 units on a scale
Standard Deviation 1.16
|
0.32 units on a scale
Standard Deviation 0.81
|
|
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Alcohol 40mg%
|
2.21 units on a scale
Standard Deviation 2.27
|
2.52 units on a scale
Standard Deviation 2.28
|
|
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Alcohol 100mg%
|
3.83 units on a scale
Standard Deviation 2.19
|
4.01 units on a scale
Standard Deviation 1.98
|
PRIMARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Placebo
|
0.1 units on a scale
Standard Deviation 0.4
|
0.14 units on a scale
Standard Deviation 0.55
|
|
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Alcohol 40mg%
|
1.19 units on a scale
Standard Deviation 1.5
|
1.31 units on a scale
Standard Deviation 1.73
|
|
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Alcohol 100mg%
|
2.97 units on a scale
Standard Deviation 2.42
|
3.12 units on a scale
Standard Deviation 2.16
|
PRIMARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Placebo
|
0.05 units on a scale
Standard Deviation 0.28
|
0.05 units on a scale
Standard Deviation 0.35
|
|
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Alcohol 40mg%
|
0.29 units on a scale
Standard Deviation 0.75
|
0.68 units on a scale
Standard Deviation 1.31
|
|
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Alcohol 100mg%
|
2.29 units on a scale
Standard Deviation 2.27
|
2.16 units on a scale
Standard Deviation 2.06
|
PRIMARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Placebo
|
0 units on a scale
Standard Deviation 0
|
0.01 units on a scale
Standard Deviation 0.09
|
|
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Alcohol 40mg%
|
0.1 units on a scale
Standard Deviation 0.41
|
0.21 units on a scale
Standard Deviation 0.63
|
|
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Alcohol 100mg%
|
1.37 units on a scale
Standard Deviation 1.89
|
1.41 units on a scale
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: 230 minutesPopulation: All available data was utilized in the analysis using mixed models.
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Placebo
|
0.02 units on a scale
Standard Deviation 0.13
|
0 units on a scale
Standard Deviation 0
|
|
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Alcohol 40mg%
|
0.05 units on a scale
Standard Deviation 0.29
|
0.05 units on a scale
Standard Deviation 0.25
|
|
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Alcohol 100mg%
|
0.46 units on a scale
Standard Deviation 0.92
|
0.71 units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Placebo
|
2.21 units on a scale
Standard Deviation 4.47
|
1.8 units on a scale
Standard Deviation 3.69
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Alcohol 40mg%
|
1.16 units on a scale
Standard Deviation 2.46
|
2.21 units on a scale
Standard Deviation 4.68
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Alcohol 100mg%
|
2.02 units on a scale
Standard Deviation 4.59
|
2.17 units on a scale
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Placebo
|
2.04 units on a scale
Standard Deviation 4.11
|
1.85 units on a scale
Standard Deviation 3.8
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Alcohol 40mg%
|
1.59 units on a scale
Standard Deviation 4.43
|
3.83 units on a scale
Standard Deviation 6.91
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Alcohol 100mg%
|
4.3 units on a scale
Standard Deviation 8.13
|
4.5 units on a scale
Standard Deviation 7.66
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Placebo
|
2.1 units on a scale
Standard Deviation 4.23
|
2.36 units on a scale
Standard Deviation 4.56
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Alcohol 40mg%
|
3.41 units on a scale
Standard Deviation 5.26
|
6.16 units on a scale
Standard Deviation 9.1
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Alcohol 100mg%
|
7.75 units on a scale
Standard Deviation 11.09
|
9.38 units on a scale
Standard Deviation 13.75
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Placebo
|
2.46 units on a scale
Standard Deviation 4.94
|
2.9 units on a scale
Standard Deviation 6.35
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Alcohol 40mg%
|
4.17 units on a scale
Standard Deviation 6.62
|
6.32 units on a scale
Standard Deviation 9.67
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Alcohol 100mg%
|
8.27 units on a scale
Standard Deviation 11.55
|
10.45 units on a scale
Standard Deviation 14.87
|
SECONDARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Placebo
|
1.93 units on a scale
Standard Deviation 4.11
|
1.92 units on a scale
Standard Deviation 5.36
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Alcohol 40mg%
|
4.21 units on a scale
Standard Deviation 7.95
|
4.68 units on a scale
Standard Deviation 7.38
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Alcohol 100mg%
|
7.5 units on a scale
Standard Deviation 10.65
|
9.77 units on a scale
Standard Deviation 13.55
|
SECONDARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Placebo
|
1.34 units on a scale
Standard Deviation 3.12
|
1.8 units on a scale
Standard Deviation 5.01
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Alcohol 40mg%
|
2.55 units on a scale
Standard Deviation 6.55
|
3.39 units on a scale
Standard Deviation 6.22
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Alcohol 100mg%
|
6.28 units on a scale
Standard Deviation 10.67
|
7.4 units on a scale
Standard Deviation 11.88
|
SECONDARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Placebo
|
0.79 units on a scale
Standard Deviation 2.35
|
1.22 units on a scale
Standard Deviation 4.44
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Alcohol 40mg%
|
1.4 units on a scale
Standard Deviation 3.98
|
1.96 units on a scale
Standard Deviation 4.47
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Alcohol 100mg%
|
3.97 units on a scale
Standard Deviation 6.82
|
5.78 units on a scale
Standard Deviation 11.52
|
SECONDARY outcome
Timeframe: 230 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Placebo
|
0.62 units on a scale
Standard Deviation 2.31
|
1.03 units on a scale
Standard Deviation 3.58
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Alcohol 40mg%
|
1.28 units on a scale
Standard Deviation 3.38
|
1.56 units on a scale
Standard Deviation 4.19
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Alcohol 100mg%
|
2.7 units on a scale
Standard Deviation 6.27
|
3.25 units on a scale
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Placebo
|
3.15 units on a scale
Standard Deviation 6.89
|
2.93 units on a scale
Standard Deviation 6.6
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Alcohol 40mg%
|
4.59 units on a scale
Standard Deviation 9.28
|
4.47 units on a scale
Standard Deviation 9.91
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Alcohol 100mg%
|
3.4 units on a scale
Standard Deviation 6.73
|
3.55 units on a scale
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=61 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Placebo
|
3.39 units on a scale
Standard Deviation 8.15
|
2.19 units on a scale
Standard Deviation 5.7
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Alcohol 40mg%
|
4.23 units on a scale
Standard Deviation 9.26
|
3.54 units on a scale
Standard Deviation 7.32
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Alcohol 100mg%
|
3.83 units on a scale
Standard Deviation 6.34
|
4.19 units on a scale
Standard Deviation 7.83
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Placebo
|
3.75 units on a scale
Standard Deviation 8.31
|
2.79 units on a scale
Standard Deviation 6.54
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Alcohol 40mg%
|
5.66 units on a scale
Standard Deviation 9.82
|
6.19 units on a scale
Standard Deviation 9.28
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Alcohol 100mg%
|
8.97 units on a scale
Standard Deviation 12.75
|
10.38 units on a scale
Standard Deviation 12.18
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Placebo
|
3.75 units on a scale
Standard Deviation 8.32
|
2.74 units on a scale
Standard Deviation 6.37
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Alcohol 40mg%
|
4.29 units on a scale
Standard Deviation 8.61
|
4.82 units on a scale
Standard Deviation 8.29
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Alcohol 100mg%
|
7.51 units on a scale
Standard Deviation 11.79
|
7.61 units on a scale
Standard Deviation 10.32
|
SECONDARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Placebo
|
3.15 units on a scale
Standard Deviation 7.33
|
3.92 units on a scale
Standard Deviation 7.39
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Alcohol 40mg%
|
2.83 units on a scale
Standard Deviation 7.41
|
3.62 units on a scale
Standard Deviation 7.52
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Alcohol 100mg%
|
3 units on a scale
Standard Deviation 6.22
|
4.52 units on a scale
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Placebo
|
3.12 units on a scale
Standard Deviation 6.95
|
3.79 units on a scale
Standard Deviation 8.56
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Alcohol 40mg%
|
2.79 units on a scale
Standard Deviation 6.98
|
3.3 units on a scale
Standard Deviation 7.59
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Alcohol 100mg%
|
2.35 units on a scale
Standard Deviation 4.66
|
3.79 units on a scale
Standard Deviation 7.37
|
SECONDARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Placebo
|
3.57 units on a scale
Standard Deviation 7.82
|
4.1 units on a scale
Standard Deviation 8.95
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Alcohol 40mg%
|
2.76 units on a scale
Standard Deviation 6.58
|
3.21 units on a scale
Standard Deviation 7.47
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Alcohol 100mg%
|
1.63 units on a scale
Standard Deviation 3.61
|
3.22 units on a scale
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: 240 minutesPopulation: All available data was utilized in the analysis using mixed models.
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Placebo
|
4.77 units on a scale
Standard Deviation 10.79
|
3.91 units on a scale
Standard Deviation 7.89
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Alcohol 40mg%
|
2.95 units on a scale
Standard Deviation 7.08
|
4.27 units on a scale
Standard Deviation 9.99
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Alcohol 100mg%
|
1.36 units on a scale
Standard Deviation 3.5
|
2.79 units on a scale
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - Baseline
Placebo
|
0.08 units on a scale
Standard Deviation 0.46
|
0.17 units on a scale
Standard Deviation 0.71
|
|
Visual Analog Scale (VAS) HIGH - Baseline
Alcohol 40mg%
|
0.09 units on a scale
Standard Deviation 0.47
|
0.18 units on a scale
Standard Deviation 0.88
|
|
Visual Analog Scale (VAS) HIGH - Baseline
Alcohol 100mg%
|
0.05 units on a scale
Standard Deviation 0.29
|
0.11 units on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 10 Minutes
Placebo
|
0.11 units on a scale
Standard Deviation 0.56
|
0.12 units on a scale
Standard Deviation 0.47
|
|
Visual Analog Scale (VAS) HIGH - 10 Minutes
Alcohol 40mg%
|
0.25 units on a scale
Standard Deviation 0.71
|
0.32 units on a scale
Standard Deviation 0.81
|
|
Visual Analog Scale (VAS) HIGH - 10 Minutes
Alcohol 100mg%
|
0.51 units on a scale
Standard Deviation 1.01
|
0.52 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 30 Minutes
Placebo
|
0.18 units on a scale
Standard Deviation 0.65
|
0.16 units on a scale
Standard Deviation 0.55
|
|
Visual Analog Scale (VAS) HIGH - 30 Minutes
Alcohol 40mg%
|
0.59 units on a scale
Standard Deviation 1.11
|
0.99 units on a scale
Standard Deviation 1.51
|
|
Visual Analog Scale (VAS) HIGH - 30 Minutes
Alcohol 100mg%
|
1.83 units on a scale
Standard Deviation 2.04
|
1.73 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 60 Minutes
Placebo
|
0.18 units on a scale
Standard Deviation 0.85
|
0.19 units on a scale
Standard Deviation 0.53
|
|
Visual Analog Scale (VAS) HIGH - 60 Minutes
Alcohol 40mg%
|
0.69 units on a scale
Standard Deviation 1.33
|
0.9 units on a scale
Standard Deviation 1.52
|
|
Visual Analog Scale (VAS) HIGH - 60 Minutes
Alcohol 100mg%
|
1.73 units on a scale
Standard Deviation 2.20
|
1.66 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 110 Minutes
Placebo
|
0.05 units on a scale
Standard Deviation 0.22
|
0.08 units on a scale
Standard Deviation 0.38
|
|
Visual Analog Scale (VAS) HIGH - 110 Minutes
Alcohol 40mg%
|
0.29 units on a scale
Standard Deviation 0.68
|
0.47 units on a scale
Standard Deviation 1.13
|
|
Visual Analog Scale (VAS) HIGH - 110 Minutes
Alcohol 100mg%
|
1.21 units on a scale
Standard Deviation 2.02
|
0.96 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 140 Minutes
Placebo
|
0 units on a scale
Standard Deviation 0
|
0.05 units on a scale
Standard Deviation 0.3
|
|
Visual Analog Scale (VAS) HIGH - 140 Minutes
Alcohol 40mg%
|
0.07 units on a scale
Standard Deviation 0.32
|
0.21 units on a scale
Standard Deviation 0.77
|
|
Visual Analog Scale (VAS) HIGH - 140 Minutes
Alcohol 100mg%
|
0.85 units on a scale
Standard Deviation 1.69
|
0.68 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 170 Minutes
Placebo
|
0.02 units on a scale
Standard Deviation 0.13
|
0.04 units on a scale
Standard Deviation 0.23
|
|
Visual Analog Scale (VAS) HIGH - 170 Minutes
Alcohol 40mg%
|
0.02 units on a scale
Standard Deviation 0.13
|
0.06 units on a scale
Standard Deviation 0.37
|
|
Visual Analog Scale (VAS) HIGH - 170 Minutes
Alcohol 100mg%
|
0.46 units on a scale
Standard Deviation 0.97
|
0.46 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 240 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) HIGH - 240 Minutes
Placebo
|
0.02 units on a scale
Standard Deviation 0.13
|
0.04 units on a scale
Standard Deviation 0.23
|
|
Visual Analog Scale (VAS) HIGH - 240 Minutes
Alcohol 40mg%
|
0 units on a scale
Standard Deviation 0
|
0.03 units on a scale
Standard Deviation 0.29
|
|
Visual Analog Scale (VAS) HIGH - 240 Minutes
Alcohol 100mg%
|
0.05 units on a scale
Standard Deviation 0.22
|
0.16 units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - Baseline
Placebo
|
0.61 units on a scale
Standard Deviation 1.19
|
0.7 units on a scale
Standard Deviation 1.09
|
|
Visual Analog Scale (VAS) Drowsy - Baseline
Alcohol 40mg%
|
0.47 units on a scale
Standard Deviation 0.89
|
0.71 units on a scale
Standard Deviation 1.07
|
|
Visual Analog Scale (VAS) Drowsy - Baseline
Alcohol 100mg%
|
0.62 units on a scale
Standard Deviation 1.12
|
0.87 units on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 10 Minutes
Placebo
|
0.63 units on a scale
Standard Deviation 1.07
|
0.52 units on a scale
Standard Deviation 0.94
|
|
Visual Analog Scale (VAS) Drowsy - 10 Minutes
Alcohol 40mg%
|
0.47 units on a scale
Standard Deviation 0.85
|
0.77 units on a scale
Standard Deviation 1.11
|
|
Visual Analog Scale (VAS) Drowsy - 10 Minutes
Alcohol 100mg%
|
0.87 units on a scale
Standard Deviation 1.13
|
0.96 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 30 Minutes
Placebo
|
0.53 units on a scale
Standard Deviation 0.99
|
0.51 units on a scale
Standard Deviation 0.89
|
|
Visual Analog Scale (VAS) Drowsy - 30 Minutes
Alcohol 40mg%
|
0.71 units on a scale
Standard Deviation 0.99
|
1.03 units on a scale
Standard Deviation 1.34
|
|
Visual Analog Scale (VAS) Drowsy - 30 Minutes
Alcohol 100mg%
|
1.18 units on a scale
Standard Deviation 1.64
|
1.05 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 60 Minutes
Placebo
|
0.74 units on a scale
Standard Deviation 1.11
|
0.69 units on a scale
Standard Deviation 1.24
|
|
Visual Analog Scale (VAS) Drowsy - 60 Minutes
Alcohol 40mg%
|
1.03 units on a scale
Standard Deviation 1.23
|
1.13 units on a scale
Standard Deviation 1.55
|
|
Visual Analog Scale (VAS) Drowsy - 60 Minutes
Alcohol 100mg%
|
1.14 units on a scale
Standard Deviation 1.71
|
1.27 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: 110 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 110 Minutes
Placebo
|
0.51 units on a scale
Standard Deviation 0.92
|
0.56 units on a scale
Standard Deviation 1.17
|
|
Visual Analog Scale (VAS) Drowsy - 110 Minutes
Alcohol 40mg%
|
0.95 units on a scale
Standard Deviation 1.32
|
0.98 units on a scale
Standard Deviation 1.47
|
|
Visual Analog Scale (VAS) Drowsy - 110 Minutes
Alcohol 100mg%
|
1.38 units on a scale
Standard Deviation 1.83
|
1.73 units on a scale
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: 140 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 140 Minutes
Placebo
|
0.46 units on a scale
Standard Deviation 1.04
|
0.45 units on a scale
Standard Deviation 1.04
|
|
Visual Analog Scale (VAS) Drowsy - 140 Minutes
Alcohol 40mg%
|
0.41 units on a scale
Standard Deviation 0.62
|
0.9 units on a scale
Standard Deviation 1.46
|
|
Visual Analog Scale (VAS) Drowsy - 140 Minutes
Alcohol 100mg%
|
1.35 units on a scale
Standard Deviation 1.89
|
1.60 units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 170 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 170 Minutes
Placebo
|
0.16 units on a scale
Standard Deviation 0.49
|
0.24 units on a scale
Standard Deviation 0.63
|
|
Visual Analog Scale (VAS) Drowsy - 170 Minutes
Alcohol 40mg%
|
0.26 units on a scale
Standard Deviation 0.58
|
0.61 units on a scale
Standard Deviation 1.24
|
|
Visual Analog Scale (VAS) Drowsy - 170 Minutes
Alcohol 100mg%
|
0.93 units on a scale
Standard Deviation 1.48
|
1.16 units on a scale
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: 230 minutesPopulation: All available data was utilized in the analysis using mixed models.
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Visual Analog Scale (VAS) Drowsy - 230 Minutes
Placebo
|
0.15 units on a scale
Standard Deviation 0.54
|
0.21 units on a scale
Standard Deviation 0.62
|
|
Visual Analog Scale (VAS) Drowsy - 230 Minutes
Alcohol 40mg%
|
0.29 units on a scale
Standard Deviation 0.77
|
0.35 units on a scale
Standard Deviation 0.77
|
|
Visual Analog Scale (VAS) Drowsy - 230 Minutes
Alcohol 100mg%
|
0.59 units on a scale
Standard Deviation 1.00
|
0.8 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 30 minutes - Trial 1Population: All available data was utilized in the analysis using mixed models.
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Placebo
|
7.26 units on a scale
Standard Deviation 1.64
|
7.46 units on a scale
Standard Deviation 1.72
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Alcohol 40mg%
|
7.26 units on a scale
Standard Deviation 1.32
|
7.17 units on a scale
Standard Deviation 1.59
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Alcohol 100mg%
|
6.33 units on a scale
Standard Deviation 1.4
|
6.27 units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: 30 minutes - Trial 2Population: All available data was utilized in the analysis using mixed models.
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Placebo
|
9.43 units on a scale
Standard Deviation 1.96
|
9.7 units on a scale
Standard Deviation 1.86
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Alcohol 40mg%
|
8.95 units on a scale
Standard Deviation 1.95
|
9.13 units on a scale
Standard Deviation 2.01
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Alcohol 100mg%
|
7.78 units on a scale
Standard Deviation 2.02
|
8.11 units on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: 30 minutes - Trial 3Population: All available data was utilized in the analysis using mixed models.
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Placebo
|
10.8 units on a scale
Standard Deviation 1.4
|
10.69 units on a scale
Standard Deviation 1.42
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Alcohol 40mg%
|
10.22 units on a scale
Standard Deviation 1.6
|
10.28 units on a scale
Standard Deviation 1.71
|
|
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Alcohol 100mg%
|
9.05 units on a scale
Standard Deviation 1.85
|
8.89 units on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: All available data was utilized in the analysis using mixed models.
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Delay Recall: 30 minutes after Trials 1-3 were given) (0 no words recalled - 12 all words recalled)
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Delay Recall
Placebo
|
10.48 units on a scale
Standard Deviation 1.82
|
10.08 units on a scale
Standard Deviation 2.11
|
|
Hopkins Verbal Learning Task - Delay Recall
Alcohol 40mg%
|
9.41 units on a scale
Standard Deviation 2.15
|
9.43 units on a scale
Standard Deviation 2.21
|
|
Hopkins Verbal Learning Task - Delay Recall
Alcohol 100mg%
|
7.08 units on a scale
Standard Deviation 2.81
|
6.796 units on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Pegboard Task - Baseline (Dominant Hand)
Placebo
|
63.64 seconds
Standard Deviation 8.58
|
61.58 seconds
Standard Deviation 9.95
|
|
Pegboard Task - Baseline (Dominant Hand)
Alcohol 40mg%
|
63.12 seconds
Standard Deviation 9.38
|
62.4 seconds
Standard Deviation 9.23
|
|
Pegboard Task - Baseline (Dominant Hand)
Alcohol 100mg%
|
64.07 seconds
Standard Deviation 9.27
|
63.4 seconds
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Pegboard Task - 30 Minutes (Dominant Hand)
Placebo
|
68.32 seconds
Standard Deviation 11.74
|
65.05 seconds
Standard Deviation 11.37
|
|
Pegboard Task - 30 Minutes (Dominant Hand)
Alcohol 40mg%
|
67.12 seconds
Standard Deviation 11.69
|
67.26 seconds
Standard Deviation 14.46
|
|
Pegboard Task - 30 Minutes (Dominant Hand)
Alcohol 100mg%
|
76.92 seconds
Standard Deviation 12.64
|
76.74 seconds
Standard Deviation 16.43
|
SECONDARY outcome
Timeframe: BaselinePopulation: All available data was utilized in the analysis using mixed models.
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Pegboard Task - Baseline (Non-Dominant Hand)
Placebo
|
69.36 seconds
Standard Deviation 11.03
|
66.85 seconds
Standard Deviation 10.03
|
|
Pegboard Task - Baseline (Non-Dominant Hand)
Alcohol 40mg%
|
70.19 seconds
Standard Deviation 11
|
67.87 seconds
Standard Deviation 10.28
|
|
Pegboard Task - Baseline (Non-Dominant Hand)
Alcohol 100mg%
|
70.66 seconds
Standard Deviation 10.38
|
67.16 seconds
Standard Deviation 11.03
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All available data was utilized in the analysis using mixed models.
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Outcome measures
| Measure |
Family History Positive
n=65 Participants
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 Participants
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Pegboard Task - 30 Minuites (Non-Dominant Hand)
Placebo
|
75.27 seconds
Standard Deviation 17.06
|
70.17 seconds
Standard Deviation 12.03
|
|
Pegboard Task - 30 Minuites (Non-Dominant Hand)
Alcohol 40mg%
|
75.19 seconds
Standard Deviation 15.99
|
72.76 seconds
Standard Deviation 14.29
|
|
Pegboard Task - 30 Minuites (Non-Dominant Hand)
Alcohol 100mg%
|
85.86 seconds
Standard Deviation 16.93
|
83.85 seconds
Standard Deviation 16.48
|
Adverse Events
Family History Positive
Family History Negative
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Family History Positive
n=65 participants at risk
Subjects with a positive family history of alcoholism.
|
Family History Negative
n=115 participants at risk
Subjects with no family history of alcoholism.
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
1.5%
1/65 • Number of events 1
|
0.00%
0/115
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place