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CompletedNCT00612352Updated Oct 26, 2021Results posted

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

An interventional study of Ethanol High Dose, Ethanol Low Dose, and Placebo in Alcoholism, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Yale University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
21 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcoholism

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03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 180 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Active comparator
    Family HIstory Positive

    Subjects with a positive family history of alcoholism.

    Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

  • Active comparator
    Family History Negative

    Subjects with a negative family history of alcoholism.

    Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

Interventions

  • DrugEthanol 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.

    Also known as: intravenous

06

What researchers measure

Primary outcomes

  1. Number of Drinks Felt Consumed at Baseline

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

    Time frame: Baseline

  2. Number of Drinks Felt Consumed at 10 Minutes

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

    Time frame: 10 minutes

  3. Number of Drinks Felt Consumed at 30 Minutes

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

    Time frame: 30 minutes

  4. Number of Drinks Felt Consumed at 110 Minutes

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

    Time frame: 110 minutes

  5. Number of Drinks Felt Consumed at 140 Minutes

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

    Time frame: 140 minutes

  6. Number of Drinks Felt Consumed at 170 Minutes

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

    Time frame: 170 minutes

  7. Number of Drinks Felt Consumed at 230 Minutes

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

    Time frame: 230 minutes

  8. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: Baseline

  9. Visual Analog Scale of Similarity to Alcohol -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

    Time frame: 10 minutes

  10. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 30 minutes

  11. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 60 minutes

  12. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 110 minutes

  13. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 140 minutes

  14. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 170 minutes

  15. Visual Analog Scale of Similarity to Alcohol - 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

    Time frame: 230 minutes

Secondary outcomes

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

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

    Time frame: Baseline

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

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

    Time frame: 10 minutes

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

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

    Time frame: 30 minutes

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

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

    Time frame: 60 minutes

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

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

    Time frame: 110 minutes

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

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

    Time frame: 140 minutes

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

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

    Time frame: 170 minutes

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

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

    Time frame: 230 minutes

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

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

    Time frame: Baseline

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

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

    Time frame: 10 minutes

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

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

    Time frame: 30 minutes

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

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

    Time frame: 60 minutes

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

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

    Time frame: 110 minutes

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

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

    Time frame: 140 minutes

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

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

    Time frame: 170 minutes

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

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

    Time frame: 240 minutes

  17. Visual Analog Scale (VAS) HIGH - Baseline

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

    Time frame: Baseline

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

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

    Time frame: 10 minutes

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

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

    Time frame: 30 minutes

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

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

    Time frame: 60 minutes

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

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

    Time frame: 110 minutes

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

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

    Time frame: 140 minutes

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

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

    Time frame: 170 minutes

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

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

    Time frame: 240 minutes

  25. Visual Analog Scale (VAS) Drowsy - Baseline

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

    Time frame: Baseline

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

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

    Time frame: 10 minutes

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

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

    Time frame: 30 minutes

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

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

    Time frame: 60 minutes

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

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

    Time frame: 110 minutes

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

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

    Time frame: 140 minutes

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

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

    Time frame: 170 minutes

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

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

    Time frame: 230 minutes

  33. Hopkins Verbal Learning Task - Immediate Recall - 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)

    Time frame: 30 minutes - Trial 1

  34. Hopkins Verbal Learning Task - Immediate Recall - 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)

    Time frame: 30 minutes - Trial 2

  35. Hopkins Verbal Learning Task - Immediate Recall - 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)

    Time frame: 30 minutes - Trial 3

  36. Hopkins Verbal Learning Task - Delay Recall

    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

  37. Pegboard Task - Baseline (Dominant Hand)

    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

  38. Pegboard Task - 30 Minutes (Dominant Hand)

    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

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

    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

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

    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

07

Results

Posted Feb 24, 2017

Participant flow

Participant flow — Overall Study
MilestoneFamily History PositiveFamily History Negative
Started65115
40%mg & 100%mg11
Placebo & 100%mg10
100%mg21
40%mg10
Placebo44
Completed56109
Not completed96
Withdrew: Adverse event10
Withdrew: Withdrawal by subject35
Withdrew: Moved out of state10
Withdrew: Didn't return calls/show up on test date41

Outcome measures

PrimaryNumber of Drinks Felt Consumed at Baseline

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

Time frame:
Baseline
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at Baseline
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0 ± 00 ± 0
Alcohol 40mg%0 ± 00 ± 0
Alcohol 100mg%0 ± 00.04 ± 0.23
PrimaryNumber of Drinks Felt Consumed at 10 Minutes

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

Time frame:
10 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 10 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0.07 ± 0.420.08 ± 0.37
Alcohol 40mg%0.49 ± 0.80.7 ± 0.92
Alcohol 100mg%0.76 ± 1.071.15 ± 1.18
PrimaryNumber of Drinks Felt Consumed at 30 Minutes

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

Time frame:
30 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 30 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0.2 ± 0.50.27 ± 0.67
Alcohol 40mg%1.88 ± 1.112.03 ± 1.68
Alcohol 100mg%3.65 ± 1.613.86 ± 2.0
PrimaryNumber of Drinks Felt Consumed at 110 Minutes

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

Time frame:
110 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 110 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0.1 ± 0.40.09 ± 0.4
Alcohol 40mg%0.97 ± 0.971.2 ± 1.39
Alcohol 100mg%3.22 ± 1.613.64 ± 2.0
PrimaryNumber of Drinks Felt Consumed at 140 Minutes

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

Time frame:
140 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 140 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0.03 ± 0.180.04 ± 0.23
Alcohol 40mg%0.33 ± 0.630.46 ± 0.88
Alcohol 100mg%2.12 ± 1.792.53 ± 2.78
PrimaryNumber of Drinks Felt Consumed at 170 Minutes

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

Time frame:
170 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 170 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0 ± 00 ± 0
Alcohol 40mg%0.07 ± 0.320.11 ± 0.39
Alcohol 100mg%1.19 ± 1.51.39 ± 2.24
PrimaryNumber of Drinks Felt Consumed at 230 Minutes

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

Time frame:
230 minutes
Reported as:
Mean · drinks felt consumed
Number of Drinks Felt Consumed at 230 Minutes
drinks felt consumedFamily History PositiveFamily History Negative
Placebo0 ± 00 ± 0
Alcohol 40mg%0.03 ± 0.260.03 ± 0.21
Alcohol 100mg%0.37 ± 0.790.55 ± 1.16
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
Baseline
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - Baseline
units on a scaleFamily History PositiveFamily History Negative
Placebo0.08 ± 0.640.13 ± 0.65
Alcohol 40mg%0.1 ± 0.410.1 ± 0.62
Alcohol 100mg%0.02 ± 0.130.1 ± 0.59
PrimaryVisual Analog Scale of Similarity to Alcohol -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

Time frame:
10 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol -10 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.16 ± 0.730.12 ± 0.41
Alcohol 40mg%0.76 ± 1.31.13 ± 1.6
Alcohol 100mg%1.59 ± 2.21.56 ± 1.81
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
30 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.36 ± 1.080.33 ± 0.69
Alcohol 40mg%2.05 ± 2.062.62 ± 2.25
Alcohol 100mg%3.82 ± 2.053.98 ± 1.82
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
60 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.36 ± 1.160.32 ± 0.81
Alcohol 40mg%2.21 ± 2.272.52 ± 2.28
Alcohol 100mg%3.83 ± 2.194.01 ± 1.98
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
110 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.1 ± 0.40.14 ± 0.55
Alcohol 40mg%1.19 ± 1.51.31 ± 1.73
Alcohol 100mg%2.97 ± 2.423.12 ± 2.16
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
140 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.05 ± 0.280.05 ± 0.35
Alcohol 40mg%0.29 ± 0.750.68 ± 1.31
Alcohol 100mg%2.29 ± 2.272.16 ± 2.06
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
170 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0 ± 00.01 ± 0.09
Alcohol 40mg%0.1 ± 0.410.21 ± 0.63
Alcohol 100mg%1.37 ± 1.891.41 ± 1.81
PrimaryVisual Analog Scale of Similarity to Alcohol - 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

Time frame:
230 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.02 ± 0.130 ± 0
Alcohol 40mg%0.05 ± 0.290.05 ± 0.25
Alcohol 100mg%0.46 ± 0.920.71 ± 1.42
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline

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

Time frame:
Baseline
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
units on a scaleFamily History PositiveFamily History Negative
Placebo2.21 ± 4.471.8 ± 3.69
Alcohol 40mg%1.16 ± 2.462.21 ± 4.68
Alcohol 100mg%2.02 ± 4.592.17 ± 4.29
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes

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

Time frame:
10 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo2.04 ± 4.111.85 ± 3.8
Alcohol 40mg%1.59 ± 4.433.83 ± 6.91
Alcohol 100mg%4.3 ± 8.134.5 ± 7.66
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes

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

Time frame:
30 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo2.1 ± 4.232.36 ± 4.56
Alcohol 40mg%3.41 ± 5.266.16 ± 9.1
Alcohol 100mg%7.75 ± 11.099.38 ± 13.75
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes

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

Time frame:
60 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo2.46 ± 4.942.9 ± 6.35
Alcohol 40mg%4.17 ± 6.626.32 ± 9.67
Alcohol 100mg%8.27 ± 11.5510.45 ± 14.87
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes

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

Time frame:
110 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo1.93 ± 4.111.92 ± 5.36
Alcohol 40mg%4.21 ± 7.954.68 ± 7.38
Alcohol 100mg%7.5 ± 10.659.77 ± 13.55
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes

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

Time frame:
140 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo1.34 ± 3.121.8 ± 5.01
Alcohol 40mg%2.55 ± 6.553.39 ± 6.22
Alcohol 100mg%6.28 ± 10.677.4 ± 11.88
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes

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

Time frame:
170 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.79 ± 2.351.22 ± 4.44
Alcohol 40mg%1.4 ± 3.981.96 ± 4.47
Alcohol 100mg%3.97 ± 6.825.78 ± 11.52
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes

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

Time frame:
230 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.62 ± 2.311.03 ± 3.58
Alcohol 40mg%1.28 ± 3.381.56 ± 4.19
Alcohol 100mg%2.7 ± 6.273.25 ± 6.15
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline

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

Time frame:
Baseline
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
units on a scaleFamily History PositiveFamily History Negative
Placebo3.15 ± 6.892.93 ± 6.6
Alcohol 40mg%4.59 ± 9.284.47 ± 9.91
Alcohol 100mg%3.4 ± 6.733.55 ± 7.41
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes

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

Time frame:
10 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.39 ± 8.152.19 ± 5.7
Alcohol 40mg%4.23 ± 9.263.54 ± 7.32
Alcohol 100mg%3.83 ± 6.344.19 ± 7.83
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes

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

Time frame:
30 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.75 ± 8.312.79 ± 6.54
Alcohol 40mg%5.66 ± 9.826.19 ± 9.28
Alcohol 100mg%8.97 ± 12.7510.38 ± 12.18
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes

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

Time frame:
60 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.75 ± 8.322.74 ± 6.37
Alcohol 40mg%4.29 ± 8.614.82 ± 8.29
Alcohol 100mg%7.51 ± 11.797.61 ± 10.32
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes

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

Time frame:
110 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.15 ± 7.333.92 ± 7.39
Alcohol 40mg%2.83 ± 7.413.62 ± 7.52
Alcohol 100mg%3 ± 6.224.52 ± 8.06
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes

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

Time frame:
140 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.12 ± 6.953.79 ± 8.56
Alcohol 40mg%2.79 ± 6.983.3 ± 7.59
Alcohol 100mg%2.35 ± 4.663.79 ± 7.37
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes

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

Time frame:
170 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo3.57 ± 7.824.1 ± 8.95
Alcohol 40mg%2.76 ± 6.583.21 ± 7.47
Alcohol 100mg%1.63 ± 3.613.22 ± 6.92
SecondaryBiphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes

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

Time frame:
240 minutes
Reported as:
Mean · units on a scale
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo4.77 ± 10.793.91 ± 7.89
Alcohol 40mg%2.95 ± 7.084.27 ± 9.99
Alcohol 100mg%1.36 ± 3.52.79 ± 6.46
SecondaryVisual Analog Scale (VAS) HIGH - Baseline

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

Time frame:
Baseline
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - Baseline
units on a scaleFamily History PositiveFamily History Negative
Placebo0.08 ± 0.460.17 ± 0.71
Alcohol 40mg%0.09 ± 0.470.18 ± 0.88
Alcohol 100mg%0.05 ± 0.290.11 ± 0.53
SecondaryVisual Analog Scale (VAS) HIGH - 10 Minutes

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

Time frame:
10 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 10 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.11 ± 0.560.12 ± 0.47
Alcohol 40mg%0.25 ± 0.710.32 ± 0.81
Alcohol 100mg%0.51 ± 1.010.52 ± 1.03
SecondaryVisual Analog Scale (VAS) HIGH - 30 Minutes

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

Time frame:
30 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 30 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.18 ± 0.650.16 ± 0.55
Alcohol 40mg%0.59 ± 1.110.99 ± 1.51
Alcohol 100mg%1.83 ± 2.041.73 ± 1.99
SecondaryVisual Analog Scale (VAS) HIGH - 60 Minutes

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

Time frame:
60 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 60 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.18 ± 0.850.19 ± 0.53
Alcohol 40mg%0.69 ± 1.330.9 ± 1.52
Alcohol 100mg%1.73 ± 2.201.66 ± 1.96
SecondaryVisual Analog Scale (VAS) HIGH - 110 Minutes

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

Time frame:
110 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 110 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.05 ± 0.220.08 ± 0.38
Alcohol 40mg%0.29 ± 0.680.47 ± 1.13
Alcohol 100mg%1.21 ± 2.020.96 ± 1.58
SecondaryVisual Analog Scale (VAS) HIGH - 140 Minutes

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

Time frame:
140 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 140 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0 ± 00.05 ± 0.3
Alcohol 40mg%0.07 ± 0.320.21 ± 0.77
Alcohol 100mg%0.85 ± 1.690.68 ± 1.41
SecondaryVisual Analog Scale (VAS) HIGH - 170 Minutes

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

Time frame:
170 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 170 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.02 ± 0.130.04 ± 0.23
Alcohol 40mg%0.02 ± 0.130.06 ± 0.37
Alcohol 100mg%0.46 ± 0.970.46 ± 1.13
SecondaryVisual Analog Scale (VAS) HIGH - 240 Minutes

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

Time frame:
240 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) HIGH - 240 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.02 ± 0.130.04 ± 0.23
Alcohol 40mg%0 ± 00.03 ± 0.29
Alcohol 100mg%0.05 ± 0.220.16 ± 0.57
SecondaryVisual Analog Scale (VAS) Drowsy - Baseline

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

Time frame:
Baseline
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - Baseline
units on a scaleFamily History PositiveFamily History Negative
Placebo0.61 ± 1.190.7 ± 1.09
Alcohol 40mg%0.47 ± 0.890.71 ± 1.07
Alcohol 100mg%0.62 ± 1.120.87 ± 1.32
SecondaryVisual Analog Scale (VAS) Drowsy - 10 Minutes

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

Time frame:
10 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 10 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.63 ± 1.070.52 ± 0.94
Alcohol 40mg%0.47 ± 0.850.77 ± 1.11
Alcohol 100mg%0.87 ± 1.130.96 ± 1.34
SecondaryVisual Analog Scale (VAS) Drowsy - 30 Minutes

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

Time frame:
30 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 30 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.53 ± 0.990.51 ± 0.89
Alcohol 40mg%0.71 ± 0.991.03 ± 1.34
Alcohol 100mg%1.18 ± 1.641.05 ± 1.75
SecondaryVisual Analog Scale (VAS) Drowsy - 60 Minutes

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

Time frame:
60 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 60 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.74 ± 1.110.69 ± 1.24
Alcohol 40mg%1.03 ± 1.231.13 ± 1.55
Alcohol 100mg%1.14 ± 1.711.27 ± 1.99
SecondaryVisual Analog Scale (VAS) Drowsy - 110 Minutes

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

Time frame:
110 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 110 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.51 ± 0.920.56 ± 1.17
Alcohol 40mg%0.95 ± 1.320.98 ± 1.47
Alcohol 100mg%1.38 ± 1.831.73 ± 2.16
SecondaryVisual Analog Scale (VAS) Drowsy - 140 Minutes

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

Time frame:
140 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 140 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.46 ± 1.040.45 ± 1.04
Alcohol 40mg%0.41 ± 0.620.9 ± 1.46
Alcohol 100mg%1.35 ± 1.891.60 ± 1.89
SecondaryVisual Analog Scale (VAS) Drowsy - 170 Minutes

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

Time frame:
170 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 170 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.16 ± 0.490.24 ± 0.63
Alcohol 40mg%0.26 ± 0.580.61 ± 1.24
Alcohol 100mg%0.93 ± 1.481.16 ± 1.72
SecondaryVisual Analog Scale (VAS) Drowsy - 230 Minutes

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

Time frame:
230 minutes
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS) Drowsy - 230 Minutes
units on a scaleFamily History PositiveFamily History Negative
Placebo0.15 ± 0.540.21 ± 0.62
Alcohol 40mg%0.29 ± 0.770.35 ± 0.77
Alcohol 100mg%0.59 ± 1.000.8 ± 1.16
SecondaryHopkins Verbal Learning Task - Immediate Recall - 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)

Time frame:
30 minutes - Trial 1
Reported as:
Mean · units on a scale
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
units on a scaleFamily History PositiveFamily History Negative
Placebo7.26 ± 1.647.46 ± 1.72
Alcohol 40mg%7.26 ± 1.327.17 ± 1.59
Alcohol 100mg%6.33 ± 1.46.27 ± 1.63
SecondaryHopkins Verbal Learning Task - Immediate Recall - 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)

Time frame:
30 minutes - Trial 2
Reported as:
Mean · units on a scale
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
units on a scaleFamily History PositiveFamily History Negative
Placebo9.43 ± 1.969.7 ± 1.86
Alcohol 40mg%8.95 ± 1.959.13 ± 2.01
Alcohol 100mg%7.78 ± 2.028.11 ± 2.03
SecondaryHopkins Verbal Learning Task - Immediate Recall - 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)

Time frame:
30 minutes - Trial 3
Reported as:
Mean · units on a scale
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
units on a scaleFamily History PositiveFamily History Negative
Placebo10.8 ± 1.410.69 ± 1.42
Alcohol 40mg%10.22 ± 1.610.28 ± 1.71
Alcohol 100mg%9.05 ± 1.858.89 ± 2.17
SecondaryHopkins Verbal Learning Task - Delay Recall

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
Reported as:
Mean · units on a scale
Hopkins Verbal Learning Task - Delay Recall
units on a scaleFamily History PositiveFamily History Negative
Placebo10.48 ± 1.8210.08 ± 2.11
Alcohol 40mg%9.41 ± 2.159.43 ± 2.21
Alcohol 100mg%7.08 ± 2.816.796 ± 2.95
SecondaryPegboard Task - Baseline (Dominant Hand)

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
Reported as:
Mean · seconds
Pegboard Task - Baseline (Dominant Hand)
secondsFamily History PositiveFamily History Negative
Placebo63.64 ± 8.5861.58 ± 9.95
Alcohol 40mg%63.12 ± 9.3862.4 ± 9.23
Alcohol 100mg%64.07 ± 9.2763.4 ± 21.4
SecondaryPegboard Task - 30 Minutes (Dominant Hand)

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
Reported as:
Mean · seconds
Pegboard Task - 30 Minutes (Dominant Hand)
secondsFamily History PositiveFamily History Negative
Placebo68.32 ± 11.7465.05 ± 11.37
Alcohol 40mg%67.12 ± 11.6967.26 ± 14.46
Alcohol 100mg%76.92 ± 12.6476.74 ± 16.43
SecondaryPegboard Task - Baseline (Non-Dominant Hand)

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
Reported as:
Mean · seconds
Pegboard Task - Baseline (Non-Dominant Hand)
secondsFamily History PositiveFamily History Negative
Placebo69.36 ± 11.0366.85 ± 10.03
Alcohol 40mg%70.19 ± 1167.87 ± 10.28
Alcohol 100mg%70.66 ± 10.3867.16 ± 11.03
SecondaryPegboard Task - 30 Minuites (Non-Dominant Hand)

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
Reported as:
Mean · seconds
Pegboard Task - 30 Minuites (Non-Dominant Hand)
secondsFamily History PositiveFamily History Negative
Placebo75.27 ± 17.0670.17 ± 12.03
Alcohol 40mg%75.19 ± 15.9972.76 ± 14.29
Alcohol 100mg%85.86 ± 16.9383.85 ± 16.48

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Family History Positive—0/65 (0%)1/65 (1.5%)
Family History Negative—0/115 (0%)0/115 (0%)
Most frequent other events
Most frequent other events
EventFamily History PositiveFamily History Negative
vomitingGastrointestinal disorders1/650/115

Baseline characteristics

Age, Continuous
Age, Continuous(years)Family History PositiveFamily History NegativeTotal
Mean24.06 ± 2.9724.1 ± 2.3824.08 ± 2.60
Sex: Female, Male
Sex: Female, Male(Participants)Family History PositiveFamily History NegativeTotal
Female325688
Male335992
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Family History PositiveFamily History NegativeTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101424
White5188139
More than one race000
Unknown or Not Reported41317
08

Study locations

1 site
  • VA Connecticut Healthcare System
    West Haven, Connecticut 06516, United States
09

References and documents

Publications

  • Ralevski E, Perrino A, Acampora G, Koretski J, Limoncelli D, Petrakis I. Analgesic effects of ethanol are influenced by family history of alcoholism and neuroticism. Alcohol Clin Exp Res. 2010 Aug;34(8):1433-41. doi: 10.1111/j.1530-0277.2010.01228.x. Epub 2010 May 21. PubMed 20497133 ↗
  • Perrino AC Jr, Ralevski E, Acampora G, Edgecombe J, Limoncelli D, Petrakis IL. Ethanol and pain sensitivity: effects in healthy subjects using an acute pain paradigm. Alcohol Clin Exp Res. 2008 Jun;32(6):952-8. doi: 10.1111/j.1530-0277.2008.00653.x. Epub 2008 Apr 26. PubMed 18445106 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00612352
Lead sponsor
Yale University
Collaborators
VA Connecticut Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Feb 11, 2008
Start date
Mar 2001
Primary completion
Jun 2015
Completion
Jun 2015
Results posted
Feb 24, 2017
Last update
Oct 26, 2021

Study contacts

Ismene L Petrakis, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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