ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00612352
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Collaborators:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Condition Alcoholism
Intervention Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description Subjects with a positive family history of alcoholism. Subjects with no family history of alcoholism.
Period Title: Overall Study
Started 65 115
40%mg & 100%mg [1] 1 1
Placebo & 100%mg [2] 1 0
100%mg [3] 2 1
40%mg [4] 1 0
Placebo [5] 4 4
Completed [6] 56 109
Not Completed 9 6
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             3             5
moved out of state             1             0
didn't return calls/show up on test date             4             1
[1]
Subjects that completed 2 test days (40%mg ethanol & 100%mg ethanol)
[2]
Subjects that completed 2 test days (placebo & 100%mg ethanol)
[3]
Subjects that completed 1 test day (100%mg ethanol)
[4]
Subjects that completed 1 test day (40%mg ethanol)
[5]
Subjects that completed 1 test day (placebo)
[6]
Completed all three test dates.
Arm/Group Title Family History Positive Family History Negative Total
Hide Arm/Group Description Subjects with a positive family history of alcoholism. Subjects with no family history of alcoholism. Total of all reporting groups
Overall Number of Baseline Participants 65 115 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 115 participants 180 participants
24.06  (2.97) 24.1  (2.38) 24.08  (2.60)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 115 participants 180 participants
Female
32
  49.2%
56
  48.7%
88
  48.9%
Male
33
  50.8%
59
  51.3%
92
  51.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 115 participants 180 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  15.4%
14
  12.2%
24
  13.3%
White
51
  78.5%
88
  76.5%
139
  77.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   6.2%
13
  11.3%
17
   9.4%
1.Primary Outcome
Title Number of Drinks Felt Consumed at Baseline
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0  (0) 0  (0)
Alcohol 40mg% 0  (0) 0  (0)
Alcohol 100mg% 0  (0) 0.04  (0.23)
2.Primary Outcome
Title Number of Drinks Felt Consumed at 10 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 58 92
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0.07  (0.42) 0.08  (0.37)
Alcohol 40mg% 0.49  (0.8) 0.7  (0.92)
Alcohol 100mg% 0.76  (1.07) 1.15  (1.18)
3.Primary Outcome
Title Number of Drinks Felt Consumed at 30 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0.2  (0.5) 0.27  (0.67)
Alcohol 40mg% 1.88  (1.11) 2.03  (1.68)
Alcohol 100mg% 3.65  (1.61) 3.86  (2.0)
4.Primary Outcome
Title Number of Drinks Felt Consumed at 110 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0.1  (0.4) 0.09  (0.4)
Alcohol 40mg% 0.97  (0.97) 1.2  (1.39)
Alcohol 100mg% 3.22  (1.61) 3.64  (2.0)
5.Primary Outcome
Title Number of Drinks Felt Consumed at 140 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0.03  (0.18) 0.04  (0.23)
Alcohol 40mg% 0.33  (0.63) 0.46  (0.88)
Alcohol 100mg% 2.12  (1.79) 2.53  (2.78)
6.Primary Outcome
Title Number of Drinks Felt Consumed at 170 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0  (0) 0  (0)
Alcohol 40mg% 0.07  (0.32) 0.11  (0.39)
Alcohol 100mg% 1.19  (1.5) 1.39  (2.24)
7.Primary Outcome
Title Number of Drinks Felt Consumed at 230 Minutes
Hide Description The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame 230 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: drinks felt consumed
Placebo 0  (0) 0  (0)
Alcohol 40mg% 0.03  (0.26) 0.03  (0.21)
Alcohol 100mg% 0.37  (0.79) 0.55  (1.16)
8.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - Baseline
Hide Description 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
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.08  (0.64) 0.13  (0.65)
Alcohol 40mg% 0.1  (0.41) 0.1  (0.62)
Alcohol 100mg% 0.02  (0.13) 0.1  (0.59)
9.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol -10 Minutes
Hide Description 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
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 56 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.16  (0.73) 0.12  (0.41)
Alcohol 40mg% 0.76  (1.3) 1.13  (1.6)
Alcohol 100mg% 1.59  (2.2) 1.56  (1.81)
10.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Hide Description 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
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.36  (1.08) 0.33  (0.69)
Alcohol 40mg% 2.05  (2.06) 2.62  (2.25)
Alcohol 100mg% 3.82  (2.05) 3.98  (1.82)
11.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Hide Description 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
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.36  (1.16) 0.32  (0.81)
Alcohol 40mg% 2.21  (2.27) 2.52  (2.28)
Alcohol 100mg% 3.83  (2.19) 4.01  (1.98)
12.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Hide Description 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
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.1  (0.4) 0.14  (0.55)
Alcohol 40mg% 1.19  (1.5) 1.31  (1.73)
Alcohol 100mg% 2.97  (2.42) 3.12  (2.16)
13.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Hide Description 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
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.05  (0.28) 0.05  (0.35)
Alcohol 40mg% 0.29  (0.75) 0.68  (1.31)
Alcohol 100mg% 2.29  (2.27) 2.16  (2.06)
14.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Hide Description 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
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0  (0) 0.01  (0.09)
Alcohol 40mg% 0.1  (0.41) 0.21  (0.63)
Alcohol 100mg% 1.37  (1.89) 1.41  (1.81)
15.Primary Outcome
Title Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Hide Description 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
Time Frame 230 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.02  (0.13) 0  (0)
Alcohol 40mg% 0.05  (0.29) 0.05  (0.25)
Alcohol 100mg% 0.46  (0.92) 0.71  (1.42)
16.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 2.21  (4.47) 1.8  (3.69)
Alcohol 40mg% 1.16  (2.46) 2.21  (4.68)
Alcohol 100mg% 2.02  (4.59) 2.17  (4.29)
17.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 56 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 2.04  (4.11) 1.85  (3.8)
Alcohol 40mg% 1.59  (4.43) 3.83  (6.91)
Alcohol 100mg% 4.3  (8.13) 4.5  (7.66)
18.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 2.1  (4.23) 2.36  (4.56)
Alcohol 40mg% 3.41  (5.26) 6.16  (9.1)
Alcohol 100mg% 7.75  (11.09) 9.38  (13.75)
19.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 2.46  (4.94) 2.9  (6.35)
Alcohol 40mg% 4.17  (6.62) 6.32  (9.67)
Alcohol 100mg% 8.27  (11.55) 10.45  (14.87)
20.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 1.93  (4.11) 1.92  (5.36)
Alcohol 40mg% 4.21  (7.95) 4.68  (7.38)
Alcohol 100mg% 7.5  (10.65) 9.77  (13.55)
21.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 1.34  (3.12) 1.8  (5.01)
Alcohol 40mg% 2.55  (6.55) 3.39  (6.22)
Alcohol 100mg% 6.28  (10.67) 7.4  (11.88)
22.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.79  (2.35) 1.22  (4.44)
Alcohol 40mg% 1.4  (3.98) 1.96  (4.47)
Alcohol 100mg% 3.97  (6.82) 5.78  (11.52)
23.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Hide Description Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame 230 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.62  (2.31) 1.03  (3.58)
Alcohol 40mg% 1.28  (3.38) 1.56  (4.19)
Alcohol 100mg% 2.7  (6.27) 3.25  (6.15)
24.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.15  (6.89) 2.93  (6.6)
Alcohol 40mg% 4.59  (9.28) 4.47  (9.91)
Alcohol 100mg% 3.4  (6.73) 3.55  (7.41)
25.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 56 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.39  (8.15) 2.19  (5.7)
Alcohol 40mg% 4.23  (9.26) 3.54  (7.32)
Alcohol 100mg% 3.83  (6.34) 4.19  (7.83)
26.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.75  (8.31) 2.79  (6.54)
Alcohol 40mg% 5.66  (9.82) 6.19  (9.28)
Alcohol 100mg% 8.97  (12.75) 10.38  (12.18)
27.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.75  (8.32) 2.74  (6.37)
Alcohol 40mg% 4.29  (8.61) 4.82  (8.29)
Alcohol 100mg% 7.51  (11.79) 7.61  (10.32)
28.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.15  (7.33) 3.92  (7.39)
Alcohol 40mg% 2.83  (7.41) 3.62  (7.52)
Alcohol 100mg% 3  (6.22) 4.52  (8.06)
29.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.12  (6.95) 3.79  (8.56)
Alcohol 40mg% 2.79  (6.98) 3.3  (7.59)
Alcohol 100mg% 2.35  (4.66) 3.79  (7.37)
30.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 3.57  (7.82) 4.1  (8.95)
Alcohol 40mg% 2.76  (6.58) 3.21  (7.47)
Alcohol 100mg% 1.63  (3.61) 3.22  (6.92)
31.Secondary Outcome
Title Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Hide Description Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame 240 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 4.77  (10.79) 3.91  (7.89)
Alcohol 40mg% 2.95  (7.08) 4.27  (9.99)
Alcohol 100mg% 1.36  (3.5) 2.79  (6.46)
32.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - Baseline
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.08  (0.46) 0.17  (0.71)
Alcohol 40mg% 0.09  (0.47) 0.18  (0.88)
Alcohol 100mg% 0.05  (0.29) 0.11  (0.53)
33.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 10 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 56 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.11  (0.56) 0.12  (0.47)
Alcohol 40mg% 0.25  (0.71) 0.32  (0.81)
Alcohol 100mg% 0.51  (1.01) 0.52  (1.03)
34.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 30 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.18  (0.65) 0.16  (0.55)
Alcohol 40mg% 0.59  (1.11) 0.99  (1.51)
Alcohol 100mg% 1.83  (2.04) 1.73  (1.99)
35.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 60 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.18  (0.85) 0.19  (0.53)
Alcohol 40mg% 0.69  (1.33) 0.9  (1.52)
Alcohol 100mg% 1.73  (2.20) 1.66  (1.96)
36.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 110 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.05  (0.22) 0.08  (0.38)
Alcohol 40mg% 0.29  (0.68) 0.47  (1.13)
Alcohol 100mg% 1.21  (2.02) 0.96  (1.58)
37.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 140 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0  (0) 0.05  (0.3)
Alcohol 40mg% 0.07  (0.32) 0.21  (0.77)
Alcohol 100mg% 0.85  (1.69) 0.68  (1.41)
38.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 170 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.02  (0.13) 0.04  (0.23)
Alcohol 40mg% 0.02  (0.13) 0.06  (0.37)
Alcohol 100mg% 0.46  (0.97) 0.46  (1.13)
39.Secondary Outcome
Title Visual Analog Scale (VAS) HIGH - 240 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame 240 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.02  (0.13) 0.04  (0.23)
Alcohol 40mg% 0  (0) 0.03  (0.29)
Alcohol 100mg% 0.05  (0.22) 0.16  (0.57)
40.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - Baseline
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.61  (1.19) 0.7  (1.09)
Alcohol 40mg% 0.47  (0.89) 0.71  (1.07)
Alcohol 100mg% 0.62  (1.12) 0.87  (1.32)
41.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 10 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 10 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 56 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.63  (1.07) 0.52  (0.94)
Alcohol 40mg% 0.47  (0.85) 0.77  (1.11)
Alcohol 100mg% 0.87  (1.13) 0.96  (1.34)
42.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 30 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.53  (0.99) 0.51  (0.89)
Alcohol 40mg% 0.71  (0.99) 1.03  (1.34)
Alcohol 100mg% 1.18  (1.64) 1.05  (1.75)
43.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 60 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.74  (1.11) 0.69  (1.24)
Alcohol 40mg% 1.03  (1.23) 1.13  (1.55)
Alcohol 100mg% 1.14  (1.71) 1.27  (1.99)
44.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 110 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 110 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.51  (0.92) 0.56  (1.17)
Alcohol 40mg% 0.95  (1.32) 0.98  (1.47)
Alcohol 100mg% 1.38  (1.83) 1.73  (2.16)
45.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 140 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 140 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.46  (1.04) 0.45  (1.04)
Alcohol 40mg% 0.41  (0.62) 0.9  (1.46)
Alcohol 100mg% 1.35  (1.89) 1.60  (1.89)
46.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 170 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 170 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.16  (0.49) 0.24  (0.63)
Alcohol 40mg% 0.26  (0.58) 0.61  (1.24)
Alcohol 100mg% 0.93  (1.48) 1.16  (1.72)
47.Secondary Outcome
Title Visual Analog Scale (VAS) Drowsy - 230 Minutes
Hide Description visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame 230 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 0.15  (0.54) 0.21  (0.62)
Alcohol 40mg% 0.29  (0.77) 0.35  (0.77)
Alcohol 100mg% 0.59  (1.00) 0.8  (1.16)
48.Secondary Outcome
Title Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Hide Description Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Time Frame 30 minutes - Trial 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 7.26  (1.64) 7.46  (1.72)
Alcohol 40mg% 7.26  (1.32) 7.17  (1.59)
Alcohol 100mg% 6.33  (1.4) 6.27  (1.63)
49.Secondary Outcome
Title Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Hide Description Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Time Frame 30 minutes - Trial 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 9.43  (1.96) 9.7  (1.86)
Alcohol 40mg% 8.95  (1.95) 9.13  (2.01)
Alcohol 100mg% 7.78  (2.02) 8.11  (2.03)
50.Secondary Outcome
Title Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Hide Description Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Time Frame 30 minutes - Trial 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 10.8  (1.4) 10.69  (1.42)
Alcohol 40mg% 10.22  (1.6) 10.28  (1.71)
Alcohol 100mg% 9.05  (1.85) 8.89  (2.17)
51.Secondary Outcome
Title Hopkins Verbal Learning Task - Delay Recall
Hide Description 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)
Time Frame 60 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 61 112
Mean (Standard Deviation)
Unit of Measure: units on a scale
Placebo 10.48  (1.82) 10.08  (2.11)
Alcohol 40mg% 9.41  (2.15) 9.43  (2.21)
Alcohol 100mg% 7.08  (2.81) 6.796  (2.95)
52.Secondary Outcome
Title Pegboard Task - Baseline (Dominant Hand)
Hide Description 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
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 59 111
Mean (Standard Deviation)
Unit of Measure: seconds
Placebo 63.64  (8.58) 61.58  (9.95)
Alcohol 40mg% 63.12  (9.38) 62.4  (9.23)
Alcohol 100mg% 64.07  (9.27) 63.4  (21.4)
53.Secondary Outcome
Title Pegboard Task - Baseline (Dominant Hand)
Hide Description 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.
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 59 111
Mean (Standard Deviation)
Unit of Measure: seconds
Placebo 68.32  (11.74) 65.05  (11.37)
Alcohol 40mg% 67.12  (11.69) 67.26  (14.46)
Alcohol 100mg% 76.92  (12.64) 76.74  (16.43)
54.Secondary Outcome
Title Pegboard Task - Baseline (Non-Dominant Hand)
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 59 111
Mean (Standard Deviation)
Unit of Measure: seconds
Placebo 69.36  (11.03) 66.85  (10.03)
Alcohol 40mg% 70.19  (11) 67.87  (10.28)
Alcohol 100mg% 70.66  (10.38) 67.16  (11.03)
55.Secondary Outcome
Title Pegboard Task - Baseline (Non-Dominant Hand)
Hide Description 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.
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data was utilized in the analysis using mixed models.
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description:
Subjects with a positive family history of alcoholism.
Subjects with no family history of alcoholism.
Overall Number of Participants Analyzed 59 111
Mean (Standard Deviation)
Unit of Measure: seconds
Placebo 75.27  (17.06) 70.17  (12.03)
Alcohol 40mg% 75.19  (15.99) 72.76  (14.29)
Alcohol 100mg% 85.86  (16.93) 83.85  (16.48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Family History Positive Family History Negative
Hide Arm/Group Description Subjects with a positive family history of alcoholism. Subjects with no family history of alcoholism.
All-Cause Mortality
Family History Positive Family History Negative
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Family History Positive Family History Negative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/115 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Family History Positive Family History Negative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/65 (1.54%)      0/115 (0.00%)    
Gastrointestinal disorders     
vomiting  1/65 (1.54%)  1 0/115 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ismene Petrakis
Organization: Yale University
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00612352     History of Changes
Other Study ID Numbers: 0304025194
VA Alcohol Research Center ( Other Grant/Funding Number: VA Alcohol Research Center Grant )
P50AA012870 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2007
First Posted: February 11, 2008
Results First Submitted: January 3, 2017
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017