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GABA Mechanisms Underlying the Vulnerability to Alcohol Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00611767
First Posted: February 11, 2008
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Yale University
Results First Submitted: November 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Alcoholism
Interventions: Drug: Thiopental
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Family History Negative for Alcoholism Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
Family History Positive for Alcoholism Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).

Participant Flow:   Overall Study
    Family History Negative for Alcoholism   Family History Positive for Alcoholism
STARTED   49   24 
Thiopental Test Day   3   1 
Placebo Test Day   6   1 
COMPLETED   40   22 
NOT COMPLETED   9   2 
Withdrawal by Subject                4                1 
Thiopental not available                3                0 
didn't like the medication                1                1 
Physician Decision                1                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Family History Negative for Alcoholism Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
Family History Positive for Alcoholism Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
Total Total of all reporting groups

Baseline Measures
   Family History Negative for Alcoholism   Family History Positive for Alcoholism   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   24   73 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      49 100.0%      24 100.0%      73 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.02  (2.5)   24.63  (3.06)   24.22  (2.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  51.0%      10  41.7%      35  47.9% 
Male      24  49.0%      14  58.3%      38  52.1% 
Region of Enrollment 
[Units: Participants]
     
United States   49   24   73 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analog Scales of Similarity to Alcohol - Baseline   [ Time Frame: Baseline ]

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

3.  Primary:   Visual Analog Scales of Similarity to Alcohol - 45 Minutes   [ Time Frame: 45 minutes ]

4.  Primary:   Visual Analog Scales of Similarity to Alcohol - 80 Minutes   [ Time Frame: 80 minutes ]

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

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

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

8.  Secondary:   Number of Drinks Felt Consumed at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Number of Drinks Felt Consumed - 15 Minutes   [ Time Frame: 15 minutes ]

10.  Secondary:   Number of Drinks Felt Consumed - 45 Minutes   [ Time Frame: 45 minutes ]

11.  Secondary:   Number of Drinks Felt Consumed - 80 Minutes   [ Time Frame: 80 minutes ]

12.  Secondary:   Number of Drinks Felt Consumed - 110 Minutes   [ Time Frame: 110 minutes ]

13.  Secondary:   Number of Drinks Felt Consumed - 170 Minutes   [ Time Frame: 170 minutes ]

14.  Secondary:   Number of Drinks Felt Consumed - 230 Minutes   [ Time Frame: 230 minutes ]

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

16.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 15 Minutes   [ Time Frame: 15 minutes ]

17.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 45 Minutes   [ Time Frame: 45 minutes ]

18.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 80 Minutes   [ Time Frame: 80 minutes ]

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

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

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

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

23.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 15 Minutes   [ Time Frame: 15 minutes ]

24.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 45 Minutes   [ Time Frame: 45 minutes ]

25.  Secondary:   Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 80 Minutes   [ Time Frame: 80 minutes ]

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

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

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

29.  Secondary:   Visual Analog Scales (VAS) - High - Baseline   [ Time Frame: Baseline ]

30.  Secondary:   Visual Analog Scales (VAS) - High - 15 Minutes   [ Time Frame: 15 minutes ]

31.  Secondary:   Visual Analog Scales (VAS) - High - 45 Minutes   [ Time Frame: 45 minutes ]

32.  Secondary:   Visual Analog Scales (VAS) - High - 80 Minutes   [ Time Frame: 80 minutes ]

33.  Secondary:   Visual Analog Scales (VAS) - High - 110 Minutes   [ Time Frame: 110 minutes ]

34.  Secondary:   Visual Analog Scales (VAS) - High - 170 Minutes   [ Time Frame: 170 minutes ]

35.  Secondary:   Visual Analog Scales (VAS) - High - 230 Minutes   [ Time Frame: 230 minutes ]

36.  Secondary:   Visual Analog Scales (VAS) - Buzzed - Baseline   [ Time Frame: Baseline ]

37.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 15 Minutes   [ Time Frame: 15 minutes ]

38.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 45 Minutes   [ Time Frame: 45 minutes ]

39.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 80 Minutes   [ Time Frame: 80 minutes ]

40.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 110 Minutes   [ Time Frame: 110 minutes ]

41.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 170 Minutes   [ Time Frame: 170 minutes ]

42.  Secondary:   Visual Analog Scales (VAS) - Buzzed - 230 Minutes   [ Time Frame: 230 minutes ]

43.  Secondary:   Visual Analog Scales (VAS) - Drowsy - Baseline   [ Time Frame: Baseline ]

44.  Secondary:   Visual Analog Scales (VAS) - Drowsy - 15 Minutes   [ Time Frame: 15 minutes ]

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

46.  Secondary:   Visual Analog Scales (VAS) - Drowsy - 80 Minutes   [ Time Frame: 80 minutes ]

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

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

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

50.  Secondary:   Visual Analog Scales (VAS) - Depressed - Baseline   [ Time Frame: Baseline ]

51.  Secondary:   Visual Analog Scales (VAS) - Depressed - 15 Minutes   [ Time Frame: 15 minutes ]

52.  Secondary:   Visual Analog Scales (VAS) - Depressed - 45 Minutes   [ Time Frame: 45 minutes ]

53.  Secondary:   Visual Analog Scales (VAS) - Depressed - 80 Minutes   [ Time Frame: 80 minutes ]

54.  Secondary:   Visual Analog Scales (VAS) - Depressed - 110 Minutes   [ Time Frame: 110 minutes ]

55.  Secondary:   Visual Analog Scales (VAS) - Depressed - 170 Minutes   [ Time Frame: 170 minutes ]

56.  Secondary:   Visual Analog Scales (VAS) - Depressed - 230 Minutes   [ Time Frame: 230 minutes ]

57.  Secondary:   Visual Analog Scales (VAS) - Anxious - Baseline   [ Time Frame: Baseline ]

58.  Secondary:   Visual Analog Scales (VAS) - Anxious - 15 Minutes   [ Time Frame: 15 minutes ]

59.  Secondary:   Visual Analog Scales (VAS) - Anxious - 45 Minutes   [ Time Frame: 45 minutes ]

60.  Secondary:   Visual Analog Scales (VAS) - Anxious - 80 Minutes   [ Time Frame: 80 minutes ]

61.  Secondary:   Visual Analog Scales (VAS) - Anxious - 110 Minutes   [ Time Frame: 110 minutes ]

62.  Secondary:   Visual Analog Scales (VAS) - Anxious - 170 Minutes   [ Time Frame: 170 minutes ]

63.  Secondary:   Visual Analog Scales (VAS) - Anxious - 230 Minutes   [ Time Frame: 230 minutes ]

64.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Patient Rated - Baseline   [ Time Frame: Baseline ]

65.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Patient Rated - 15 Minutes   [ Time Frame: 15 minutes ]

66.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Patient Rated - 80 Minutes   [ Time Frame: 80 minutes ]

67.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Patient Rated - 110 Minutes   [ Time Frame: 110 minutes ]

68.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Clinician Rated - Baseline   [ Time Frame: Baseline ]

69.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 15 Minutes   [ Time Frame: 15 minutes ]

70.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 80 Minutes   [ Time Frame: 80 minutes ]

71.  Secondary:   Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 110 Minutes   [ Time Frame: 110 minutes ]

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

73.  Secondary:   Pegboard Task - 15 Minutes (Dominant Hand)   [ Time Frame: 15 minutes ]

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

75.  Secondary:   Pegboard Task - 15 Minutes (Non-Dominant Hand)   [ Time Frame: 15 minutes ]

76.  Secondary:   Hopkins Verbal Learning Task (HVLT) - Total Recall   [ Time Frame: 15 minutes ]

77.  Secondary:   Hopkins Verbal Learning Task (HVLT) - Delayed Recall   [ Time Frame: 45 minutes ]

78.  Secondary:   Verbal Fluency   [ Time Frame: 15 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: Dr. Ismene L. Petrakis, Professor of Psychiatry
Organization: Yale University School of Medicine
phone: 203-932-5711 ext 2244
e-mail: Ismene.petrakis@yale.edu


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00611767     History of Changes
Other Study ID Numbers: 0510000664
VA Merit Grant
First Submitted: December 27, 2007
First Posted: February 11, 2008
Results First Submitted: November 17, 2016
Results First Posted: March 17, 2017
Last Update Posted: March 17, 2017