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

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00612352
• Collaborator: VA Connecticut Healthcare System (U.S. Fed), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 171
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high risk individuals that may lead to the transition from moderate to excessive use of alcohol.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo	N/A

Detailed Description

Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to alcohol infusion when compared to family history negative (FHN) control subjects.

Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 3 test days in a randomized balanced order under double-blind conditions. Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for over 60 minutes. Outcome measures include the Positive and Negative Symptom Scale, visual analog scales of mood state, (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) to measure perceptual responses to alcohol. Secondary measures include visual analog scales for high, similarity to ethanol, Mini Mental Status Examination (MMSE), Placement of electrodes, Biphasic Alcohol Effects Scale, Hopkins Verbal Learning, and number of drinks scale, aspects of craving for alcohol and tests of cognitive impairment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism
• Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Family HIstory Positive Subjects with a positive family history of alcoholism.	Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo; Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.; Other Names: intravenous
Active Comparator: Family History Negative Subjects with a negative family history of alcoholism.	Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo; Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.; Other Names: intravenous

Outcome Measures

Primary Outcome Measures

1. Number of Drinks Felt Consumed at Baseline [Baseline]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

2. Number of Drinks Felt Consumed at 10 Minutes [10 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

3. Number of Drinks Felt Consumed at 30 Minutes [30 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

4. Number of Drinks Felt Consumed at 110 Minutes [110 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

5. Number of Drinks Felt Consumed at 140 Minutes [140 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

6. Number of Drinks Felt Consumed at 170 Minutes [170 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

7. Number of Drinks Felt Consumed at 230 Minutes [230 minutes]

   The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.

8. Visual Analog Scale of Similarity to Alcohol - Baseline [Baseline]

   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

9. Visual Analog Scale of Similarity to Alcohol -10 Minutes [10 minutes]

   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

10. Visual Analog Scale of Similarity to Alcohol - 30 Minutes [30 minutes]

    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

11. Visual Analog Scale of Similarity to Alcohol - 60 Minutes [60 minutes]

    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

12. Visual Analog Scale of Similarity to Alcohol - 110 Minutes [110 minutes]

    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

13. Visual Analog Scale of Similarity to Alcohol - 140 Minutes [140 minutes]

    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

14. Visual Analog Scale of Similarity to Alcohol - 170 Minutes [170 minutes]

    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

15. Visual Analog Scale of Similarity to Alcohol - 230 Minutes [230 minutes]

    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

Secondary Outcome Measures

1. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline [Baseline]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

2. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes [10 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

3. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes [30 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

4. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes [60 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

5. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes [110 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

6. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes [140 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

7. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes [170 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

8. Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes [230 minutes]

   Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)

9. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline [Baseline]

   Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

10. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes [10 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

11. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes [30 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

12. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes [60 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

13. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes [110 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

14. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes [140 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

15. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes [170 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

16. Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes [240 minutes]

    Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)

17. Visual Analog Scale (VAS) HIGH - Baseline [Baseline]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

18. Visual Analog Scale (VAS) HIGH - 10 Minutes [10 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

19. Visual Analog Scale (VAS) HIGH - 30 Minutes [30 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

20. Visual Analog Scale (VAS) HIGH - 60 Minutes [60 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

21. Visual Analog Scale (VAS) HIGH - 110 Minutes [110 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

22. Visual Analog Scale (VAS) HIGH - 140 Minutes [140 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

23. Visual Analog Scale (VAS) HIGH - 170 Minutes [170 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

24. Visual Analog Scale (VAS) HIGH - 240 Minutes [240 minutes]

    visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)

25. Visual Analog Scale (VAS) Drowsy - Baseline [Baseline]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

26. Visual Analog Scale (VAS) Drowsy - 10 Minutes [10 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

27. Visual Analog Scale (VAS) Drowsy - 30 Minutes [30 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

28. Visual Analog Scale (VAS) Drowsy - 60 Minutes [60 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

29. Visual Analog Scale (VAS) Drowsy - 110 Minutes [110 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

30. Visual Analog Scale (VAS) Drowsy - 140 Minutes [140 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

31. Visual Analog Scale (VAS) Drowsy - 170 Minutes [170 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

32. Visual Analog Scale (VAS) Drowsy - 230 Minutes [230 minutes]

    visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)

33. Hopkins Verbal Learning Task - Immediate Recall - Trial 1 [30 minutes - Trial 1]

    Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)

34. Hopkins Verbal Learning Task - Immediate Recall - Trial 2 [30 minutes - Trial 2]

    Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)

35. Hopkins Verbal Learning Task - Immediate Recall - Trial 3 [30 minutes - Trial 3]

    Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)

36. Hopkins Verbal Learning Task - Delay Recall [60 minutes]

    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)

37. Pegboard Task - Baseline (Dominant Hand) [Baseline]

    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

38. Pegboard Task - 30 Minutes (Dominant Hand) [30 minutes]

    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.

39. Pegboard Task - Baseline (Non-Dominant Hand) [Baseline]

    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.

40. Pegboard Task - 30 Minuites (Non-Dominant Hand) [30 minutes]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male and female between the ages of 21 and 30 years;

2. medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.

For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.

Exclusion Criteria:

1. DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID))

2. Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months.

3. history of counseling or psychotherapy; except family therapy centered around another family member

4. extended unwillingness to remain alcohol-free for 48 hours prior to test days;

5. for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study

6. alcohol naïve

7. Adoptee and no contact with family members.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University
• VA Connecticut Healthcare System
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Ismene L Petrakis, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00612352
• Other Study ID Numbers: 0304025194; VA Alcohol Research Center; P50AA012870
• First Posted: Feb 11, 2008
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Alcoholism; Ethanol

Study Results

Participant Flow

Arm/Group Title	Family History Positive	Family History Negative
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
Placebo & 100%mg	1	0
100%mg	2	1
40%mg	1	0
Placebo	4	4
COMPLETED	56	109
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	Family History Positive	Family History Negative	Total
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.	Total of all reporting groups
Overall Participants	65	115	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.06 (2.97)	24.1 (2.38)	24.08 (2.60)
Sex: Female, Male (Count of Participants)
Female	32 49.2%	56 48.7%	88 48.9%
Male	33 50.8%	59 51.3%	92 51.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	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%
Unknown or Not Reported	4 6.2%	13 11.3%	17 9.4%

Outcome Measures

1. Primary Outcome

Title	Number of Drinks Felt Consumed at Baseline
Description	The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	110 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	140 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	170 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Time Frame	230 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	61	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	110 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	140 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	170 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Time Frame	240 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	110 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	140 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	170 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Time Frame	240 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	110 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	140 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	170 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
Description	visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Time Frame	230 minutes

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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)
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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 - 30 Minutes (Dominant Hand)
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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)
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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 - 30 Minuites (Non-Dominant Hand)
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

Outcome Measure Data

Analysis Population Description

All available data was utilized in the analysis using mixed models.

Arm/Group Title	Family History Positive	Family History Negative
Arm/Group Description	Subjects with a positive family history of alcoholism.	Subjects with no family history of alcoholism.
Measure Participants	65	115
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)

Adverse Events

Arm/Group Title	Family History Positive		Family History Negative
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Family History Positive		Family History Negative
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/115 (0%)
Other (Not Including Serious) Adverse Events
	Family History Positive		Family History Negative
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/65 (1.5%)		0/115 (0%)
Gastrointestinal disorders
vomiting	1/65 (1.5%)	1	0/115 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.