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

This study has been completed.
Sponsor:
Collaborators:
VA Connecticut Healthcare System
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00612352
First received: December 27, 2007
Last updated: January 3, 2017
Last verified: January 2017
Results First Received: January 3, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Outcomes Assessor)
Condition: Alcoholism
Intervention: Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Family History Positive Subjects with a positive family history of alcoholism.
Family History Negative Subjects with no family history of alcoholism.

Participant Flow:   Overall Study
    Family History Positive   Family History Negative
STARTED   65   115 
40%mg & 100%mg [1]   1   1 
Placebo & 100%mg [2]   1   0 
100%mg [3]   2   1 
40%mg [4]   1   0 
Placebo [5]   4   4 
COMPLETED [6]   56   109 
NOT COMPLETED   9   6 
Adverse Event                1                0 
Withdrawal by Subject                3                5 
moved out of state                1                0 
didn't return calls/show up on test date                4                1 
[1] Subjects that completed 2 test days (40%mg ethanol & 100%mg ethanol)
[2] Subjects that completed 2 test days (placebo & 100%mg ethanol)
[3] Subjects that completed 1 test day (100%mg ethanol)
[4] Subjects that completed 1 test day (40%mg ethanol)
[5] Subjects that completed 1 test day (placebo)
[6] Completed all three test dates.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Family History Positive Subjects with a positive family history of alcoholism.
Family History Negative Subjects with no family history of alcoholism.
Total Total of all reporting groups

Baseline Measures
   Family History Positive   Family History Negative   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   115   180 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.06  (2.97)   24.1  (2.38)   24.08  (2.60) 
Gender 
[Units: Participants]
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) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      10  15.4%      14  12.2%      24  13.3% 
White      51  78.5%      88  76.5%      139  77.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      4   6.2%      13  11.3%      17   9.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Drinks Felt Consumed at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Number of Drinks Felt Consumed at 10 Minutes   [ Time Frame: 10 minutes ]

3.  Primary:   Number of Drinks Felt Consumed at 30 Minutes   [ Time Frame: 30 minutes ]

4.  Primary:   Number of Drinks Felt Consumed at 110 Minutes   [ Time Frame: 110 minutes ]

5.  Primary:   Number of Drinks Felt Consumed at 140 Minutes   [ Time Frame: 140 minutes ]

6.  Primary:   Number of Drinks Felt Consumed at 170 Minutes   [ Time Frame: 170 minutes ]

7.  Primary:   Number of Drinks Felt Consumed at 230 Minutes   [ Time Frame: 230 minutes ]

8.  Primary:   Visual Analog Scale of Similarity to Alcohol - Baseline   [ Time Frame: Baseline ]

9.  Primary:   Visual Analog Scale of Similarity to Alcohol -10 Minutes   [ Time Frame: 10 minutes ]

10.  Primary:   Visual Analog Scale of Similarity to Alcohol - 30 Minutes   [ Time Frame: 30 minutes ]

11.  Primary:   Visual Analog Scale of Similarity to Alcohol - 60 Minutes   [ Time Frame: 60 minutes ]

12.  Primary:   Visual Analog Scale of Similarity to Alcohol - 110 Minutes   [ Time Frame: 110 minutes ]

13.  Primary:   Visual Analog Scale of Similarity to Alcohol - 140 Minutes   [ Time Frame: 140 minutes ]

14.  Primary:   Visual Analog Scale of Similarity to Alcohol - 170 Minutes   [ Time Frame: 170 minutes ]

15.  Primary:   Visual Analog Scale of Similarity to Alcohol - 230 Minutes   [ Time Frame: 230 minutes ]

16.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline   [ Time Frame: Baseline ]

17.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes   [ Time Frame: 10 minutes ]

18.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes   [ Time Frame: 30 minutes ]

19.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes   [ Time Frame: 60 minutes ]

20.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes   [ Time Frame: 110 minutes ]

21.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes   [ Time Frame: 140 minutes ]

22.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes   [ Time Frame: 170 minutes ]

23.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes   [ Time Frame: 230 minutes ]

24.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline   [ Time Frame: Baseline ]

25.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes   [ Time Frame: 10 minutes ]

26.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes   [ Time Frame: 30 minutes ]

27.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes   [ Time Frame: 60 minutes ]

28.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes   [ Time Frame: 110 minutes ]

29.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes   [ Time Frame: 140 minutes ]

30.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes   [ Time Frame: 170 minutes ]

31.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes   [ Time Frame: 240 minutes ]

32.  Secondary:   Visual Analog Scale (VAS) HIGH - Baseline   [ Time Frame: Baseline ]

33.  Secondary:   Visual Analog Scale (VAS) HIGH - 10 Minutes   [ Time Frame: 10 minutes ]

34.  Secondary:   Visual Analog Scale (VAS) HIGH - 30 Minutes   [ Time Frame: 30 minutes ]

35.  Secondary:   Visual Analog Scale (VAS) HIGH - 60 Minutes   [ Time Frame: 60 minutes ]

36.  Secondary:   Visual Analog Scale (VAS) HIGH - 110 Minutes   [ Time Frame: 110 minutes ]

37.  Secondary:   Visual Analog Scale (VAS) HIGH - 140 Minutes   [ Time Frame: 140 minutes ]

38.  Secondary:   Visual Analog Scale (VAS) HIGH - 170 Minutes   [ Time Frame: 170 minutes ]

39.  Secondary:   Visual Analog Scale (VAS) HIGH - 240 Minutes   [ Time Frame: 240 minutes ]

40.  Secondary:   Visual Analog Scale (VAS) Drowsy - Baseline   [ Time Frame: Baseline ]

41.  Secondary:   Visual Analog Scale (VAS) Drowsy - 10 Minutes   [ Time Frame: 10 minutes ]

42.  Secondary:   Visual Analog Scale (VAS) Drowsy - 30 Minutes   [ Time Frame: 30 minutes ]

43.  Secondary:   Visual Analog Scale (VAS) Drowsy - 60 Minutes   [ Time Frame: 60 minutes ]

44.  Secondary:   Visual Analog Scale (VAS) Drowsy - 110 Minutes   [ Time Frame: 110 minutes ]

45.  Secondary:   Visual Analog Scale (VAS) Drowsy - 140 Minutes   [ Time Frame: 140 minutes ]

46.  Secondary:   Visual Analog Scale (VAS) Drowsy - 170 Minutes   [ Time Frame: 170 minutes ]

47.  Secondary:   Visual Analog Scale (VAS) Drowsy - 230 Minutes   [ Time Frame: 230 minutes ]

48.  Secondary:   Hopkins Verbal Learning Task - Immediate Recall - Trial 1   [ Time Frame: 30 minutes - Trial 1 ]

49.  Secondary:   Hopkins Verbal Learning Task - Immediate Recall - Trial 2   [ Time Frame: 30 minutes - Trial 2 ]

50.  Secondary:   Hopkins Verbal Learning Task - Immediate Recall - Trial 3   [ Time Frame: 30 minutes - Trial 3 ]

51.  Secondary:   Hopkins Verbal Learning Task - Delay Recall   [ Time Frame: 60 minutes ]

52.  Secondary:   Pegboard Task - Baseline (Dominant Hand)   [ Time Frame: Baseline ]

53.  Secondary:   Pegboard Task - Baseline (Dominant Hand)   [ Time Frame: 30 minutes ]

54.  Secondary:   Pegboard Task - Baseline (Non-Dominant Hand)   [ Time Frame: Baseline ]

55.  Secondary:   Pegboard Task - Baseline (Non-Dominant Hand)   [ Time Frame: 30 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ismene Petrakis
Organization: Yale University
e-mail: ismene.petrakis@yale.edu


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00612352     History of Changes
Other Study ID Numbers: 0304025194
VA Alcohol Research Center ( Other Grant/Funding Number: VA Alcohol Research Center Grant )
P50AA012870 ( US NIH Grant/Contract Award Number )
Study First Received: December 27, 2007
Results First Received: January 3, 2017
Last Updated: January 3, 2017