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CRF1 Antagonist GSK561679 in Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01187511
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : November 6, 2016
Last Update Posted : November 6, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: GSK561679
Drug: Placebo
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet. Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Period Title: Overall Study
Started 22 22
Completed 14 21
Not Completed 8 1
Arm/Group Title GSK561679 Placebo Total
Hide Arm/Group Description GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet. Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679 Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
22
 100.0%
22
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Hispanic or Latino
1
   4.5%
0
   0.0%
1
   2.3%
Not Hispanic or Latino
21
  95.5%
22
 100.0%
43
  97.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 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
5
  22.7%
12
  54.5%
17
  38.6%
White
16
  72.7%
10
  45.5%
26
  59.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.5%
0
   0.0%
1
   2.3%
1.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
11.6932  (1.6713) 14.6126  (1.2775)
2.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.7646  (1.6713) 10.413  (1.295)
3.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
11.4075  (1.6713) 13.0412  (1.2775)
4.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.6218  (1.6713) 12.1841  (1.2775)
5.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
13.9789  (1.6713) 15.946  (1.2775)
6.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.9075  (1.6713) 12.1841  (1.2775)
7.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.6218  (1.6713) 11.6603  (1.2775)
8.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.9075  (1.6713) 13.1841  (1.2775)
9.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
12.1376  (1.6926) 13.1086  (1.3065)
10.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.7805  (1.6926) 10.6194  (1.297)
11.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
11.7091  (1.6926) 13.1432  (1.297)
12.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
11.3519  (1.6926) 12.1432  (1.297)
13.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
14.1376  (1.6926) 16.9051  (1.297)
14.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
11.2805  (1.6926) 12.0956  (1.297)
15.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
12.2091  (1.6926) 10.3813  (1.297)
16.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
13.1376  (1.6926) 10.0004  (1.297)
17.Secondary Outcome
Title Alcohol Craving in Response to the Trier/Cue-reactivity Procedure
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed the full Trier/cue-reactivity procedure
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 16 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
12.977  (2.0207) 12.0475  (1.7483)
18.Secondary Outcome
Title Alcohol Craving in Response to the Trier/Cue-reactivity Procedure
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed the full Trier/cue-reactivity procedure
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 16 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
15.1645  (2.0207) 12.0116  (1.7163)
19.Secondary Outcome
Title Alcohol Craving in Response to the Trier/Cue-reactivity Procedure
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed the full Trier/cue-reactivity procedure
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 16 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
18.4145  (2.0207) 15.2497  (1.7163)
20.Secondary Outcome
Title Alcohol Craving in Response to the Trier/Cue-reactivity Procedure
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed the full Trier/cue-reactivity procedure
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 16 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
20.352  (2.0207) 18.0116  (1.7163)
21.Secondary Outcome
Title Alcohol Craving in Response to the Trier/Cue-reactivity Procedure
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed the full Trier/cue-reactivity procedure
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 16 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
13.7895  (2.0207) 13.0592  (1.7163)
22.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 1 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.8582  (1.2811) 8.7076  (1.0221)
23.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 11 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.4777  (1.2117) 7.041  (1.0221)
24.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 14 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.5443  (1.2117) 6.6122  (1.0558)
25.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 18 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.011  (1.2117) 5.4219  (1.0221)
26.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.611  (1.2117) 5.7835  (1.0386)
27.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 25 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.3112  (1.239) 5.1362  (1.0221)
28.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 28 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.2231  (1.2449) 4.5648  (1.0221)
29.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 32 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.2365  (1.2878) 4.2791  (1.0221)
30.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 4 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.6777  (1.2117) 5.9457  (1.0221)
31.Secondary Outcome
Title Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 7 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.6078  (1.2379) 6.66  (1.0221)
32.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 1 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
10.002  (1.4252) 8.7759  (1.1)
33.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 11 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.3187  (1.3626) 6.2997  (1.1)
34.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 14 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.6521  (1.3626) 8.0633  (1.1268)
35.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 18 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.0521  (1.3626) 6.5855  (1.1)
36.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.0521  (1.3626) 5.9353  (1.1142)
37.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 25 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.8092  (1.3845) 4.9188  (1.1)
38.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 28 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.149  (1.3958) 4.2997  (1.1)
39.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 32 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.8071  (1.4396) 4.2045  (1.1)
40.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 4 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.2521  (1.3626) 7.1569  (1.1)
41.Secondary Outcome
Title Depression Symptom Ratings Measured Bi-weekly During the Treatment Period
Hide Description Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).
Time Frame Day 7 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.6366  (1.383) 6.9188  (1.1)
42.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 1 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
9.5572  (1.4164) 12.2152  (1.1474)
43.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 11 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.7  (1.4164) 8.8468  (1.1474)
44.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 14 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.7  (1.4164) 7.3205  (1.1474)
45.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 18 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
6.2715  (1.4164) 6.9521  (1.1474)
46.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 21 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.2715  (1.4164) 6.531  (1.1474)
47.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 25 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.6286  (1.4164) 6.6363  (1.1474)
48.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 28 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.6083  (1.4455) 6.5836  (1.1474)
49.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 32 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.7666  (1.4634) 6.531  (1.1474)
50.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 4 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
7.9858  (1.4164) 9.7942  (1.1474)
51.Secondary Outcome
Title Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period
Hide Description Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).
Time Frame Day 7 of the treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description:
GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Overall Number of Participants Analyzed 14 19
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
8.1286  (1.4164) 8.7942  (1.1474)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK561679 Placebo
Hide Arm/Group Description GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet. Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
All-Cause Mortality
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK561679 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/22 (100.00%)   22/22 (100.00%) 
Gastrointestinal disorders     
Constipation †  0/22 (0.00%)  2/22 (9.09%) 
Diarrhea †  7/22 (31.82%)  7/22 (31.82%) 
Heartburn †  1/22 (4.55%)  1/22 (4.55%) 
Nausea †  9/22 (40.91%)  7/22 (31.82%) 
Stomach pain †  7/22 (31.82%)  10/22 (45.45%) 
Upset Stomach †  8/22 (36.36%)  8/22 (36.36%) 
General disorders     
Fatigue †  15/22 (68.18%)  15/22 (68.18%) 
Musculoskeletal and connective tissue disorders     
Back Pain †  2/22 (9.09%)  2/22 (9.09%) 
Pain in Extremity †  1/22 (4.55%)  4/22 (18.18%) 
Nervous system disorders     
Dizziness †  9/22 (40.91%)  5/22 (22.73%) 
Headache †  19/22 (86.36%)  15/22 (68.18%) 
Somnolence †  21/22 (95.45%)  20/22 (90.91%) 
Psychiatric disorders     
Anxiety †  2/22 (9.09%)  1/22 (4.55%) 
Depression †  1/22 (4.55%)  1/22 (4.55%) 
Insomnia †  2/22 (9.09%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hiccups †  2/22 (9.09%)  2/22 (9.09%) 
Nasal Congestion †  15/22 (68.18%)  12/22 (54.55%) 
Skin and subcutaneous tissue disorders     
Acne †  11/22 (50.00%)  9/22 (40.91%) 
Pruritus †  3/22 (13.64%)  1/22 (4.55%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leggio, Lorenzo
Organization: National Institute on Alcohol Abuse and Alcoholism
Phone: +1 301 435 9398
EMail: lorenzo.leggio@nih.gov
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier: NCT01187511    
Other Study ID Numbers: 100046
10-AA-0046 ( Other Identifier: NIH )
First Submitted: August 21, 2010
First Posted: August 24, 2010
Results First Submitted: September 19, 2016
Results First Posted: November 6, 2016
Last Update Posted: November 6, 2016