Trial Outcomes & Findings for CRF1 Antagonist GSK561679 in Alcoholism (NCT NCT01187511)

NCT ID: NCT01187511

Last Updated: 2016-11-07

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period
• Results posted on: 2016-11-07

Participant Flow

Participant milestones

Measure	GSK561679 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 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 Study STARTED	22	22
Overall Study COMPLETED	14	21
Overall Study NOT COMPLETED	8	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CRF1 Antagonist GSK561679 in Alcoholism

Baseline characteristics by cohort

Measure	GSK561679 n=22 Participants 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 n=22 Participants 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 n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	11.6932 Units on a scale Standard Error 1.6713	14.6126 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	8.7646 Units on a scale Standard Error 1.6713	10.413 Units on a scale Standard Error 1.295

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	11.4075 Units on a scale Standard Error 1.6713	13.0412 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	9.6218 Units on a scale Standard Error 1.6713	12.1841 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	13.9789 Units on a scale Standard Error 1.6713	15.946 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	9.9075 Units on a scale Standard Error 1.6713	12.1841 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	9.6218 Units on a scale Standard Error 1.6713	11.6603 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Alcohol Cue Script	8.9075 Units on a scale Standard Error 1.6713	13.1841 Units on a scale Standard Error 1.2775

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	12.1376 Units on a scale Standard Error 1.6926	13.1086 Units on a scale Standard Error 1.3065

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	9.7805 Units on a scale Standard Error 1.6926	10.6194 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	11.7091 Units on a scale Standard Error 1.6926	13.1432 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	11.3519 Units on a scale Standard Error 1.6926	12.1432 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	14.1376 Units on a scale Standard Error 1.6926	16.9051 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	11.2805 Units on a scale Standard Error 1.6926	12.0956 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	12.2091 Units on a scale Standard Error 1.6926	10.3813 Units on a scale Standard Error 1.297

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Stress Script	13.1376 Units on a scale Standard Error 1.6926	10.0004 Units on a scale Standard Error 1.297

SECONDARY outcome

Timeframe: 100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Population: The analyses included only those subjects who completed the full Trier/cue-reactivity procedure

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).

Outcome measures

Measure	GSK561679 n=16 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Trier/Cue-reactivity Procedure	12.977 Units on a scale Standard Error 2.0207	12.0475 Units on a scale Standard Error 1.7483

SECONDARY outcome

Timeframe: 15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Population: The analyses included only those subjects who completed the full Trier/cue-reactivity procedure

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).

Outcome measures

Measure	GSK561679 n=16 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Trier/Cue-reactivity Procedure	15.1645 Units on a scale Standard Error 2.0207	12.0116 Units on a scale Standard Error 1.7163

SECONDARY outcome

Timeframe: 20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Population: The analyses included only those subjects who completed the full Trier/cue-reactivity procedure

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).

Outcome measures

Measure	GSK561679 n=16 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Trier/Cue-reactivity Procedure	18.4145 Units on a scale Standard Error 2.0207	15.2497 Units on a scale Standard Error 1.7163

SECONDARY outcome

Timeframe: 40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Population: The analyses included only those subjects who completed the full Trier/cue-reactivity procedure

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).

Outcome measures

Measure	GSK561679 n=16 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Trier/Cue-reactivity Procedure	20.352 Units on a scale Standard Error 2.0207	18.0116 Units on a scale Standard Error 1.7163

SECONDARY outcome

Timeframe: 70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Population: The analyses included only those subjects who completed the full Trier/cue-reactivity procedure

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).

Outcome measures

Measure	GSK561679 n=16 Participants 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 n=21 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Alcohol Craving in Response to the Trier/Cue-reactivity Procedure	13.7895 Units on a scale Standard Error 2.0207	13.0592 Units on a scale Standard Error 1.7163

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	7.8582 Units on a scale Standard Error 1.2811	8.7076 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 11 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.4777 Units on a scale Standard Error 1.2117	7.041 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.5443 Units on a scale Standard Error 1.2117	6.6122 Units on a scale Standard Error 1.0558

SECONDARY outcome

Timeframe: Day 18 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.011 Units on a scale Standard Error 1.2117	5.4219 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.611 Units on a scale Standard Error 1.2117	5.7835 Units on a scale Standard Error 1.0386

SECONDARY outcome

Timeframe: Day 25 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	5.3112 Units on a scale Standard Error 1.239	5.1362 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	7.2231 Units on a scale Standard Error 1.2449	4.5648 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 32 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	5.2365 Units on a scale Standard Error 1.2878	4.2791 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 4 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.6777 Units on a scale Standard Error 1.2117	5.9457 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	6.6078 Units on a scale Standard Error 1.2379	6.66 Units on a scale Standard Error 1.0221

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	10.002 Units on a scale Standard Error 1.4252	8.7759 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 11 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	6.3187 Units on a scale Standard Error 1.3626	6.2997 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	7.6521 Units on a scale Standard Error 1.3626	8.0633 Units on a scale Standard Error 1.1268

SECONDARY outcome

Timeframe: Day 18 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	8.0521 Units on a scale Standard Error 1.3626	6.5855 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	7.0521 Units on a scale Standard Error 1.3626	5.9353 Units on a scale Standard Error 1.1142

SECONDARY outcome

Timeframe: Day 25 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	4.8092 Units on a scale Standard Error 1.3845	4.9188 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	7.149 Units on a scale Standard Error 1.3958	4.2997 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 32 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	4.8071 Units on a scale Standard Error 1.4396	4.2045 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 4 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	8.2521 Units on a scale Standard Error 1.3626	7.1569 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	6.6366 Units on a scale Standard Error 1.383	6.9188 Units on a scale Standard Error 1.1

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	9.5572 Units on a scale Standard Error 1.4164	12.2152 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 11 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	7.7 Units on a scale Standard Error 1.4164	8.8468 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	5.7 Units on a scale Standard Error 1.4164	7.3205 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 18 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	6.2715 Units on a scale Standard Error 1.4164	6.9521 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	5.2715 Units on a scale Standard Error 1.4164	6.531 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 25 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	4.6286 Units on a scale Standard Error 1.4164	6.6363 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	3.6083 Units on a scale Standard Error 1.4455	6.5836 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 32 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	3.7666 Units on a scale Standard Error 1.4634	6.531 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 4 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	7.9858 Units on a scale Standard Error 1.4164	9.7942 Units on a scale Standard Error 1.1474

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: 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

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).

Outcome measures

Measure	GSK561679 n=14 Participants 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 n=19 Participants Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	8.1286 Units on a scale Standard Error 1.4164	8.7942 Units on a scale Standard Error 1.1474

Adverse Events

GSK561679

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GSK561679 n=22 participants at risk 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 n=22 participants at risk Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Gastrointestinal disorders Constipation	0.00% 0/22	9.1% 2/22
Gastrointestinal disorders Diarrhea	31.8% 7/22	31.8% 7/22
Gastrointestinal disorders Heartburn	4.5% 1/22	4.5% 1/22
Gastrointestinal disorders Nausea	40.9% 9/22	31.8% 7/22
Gastrointestinal disorders Stomach pain	31.8% 7/22	45.5% 10/22
Gastrointestinal disorders Upset Stomach	36.4% 8/22	36.4% 8/22
General disorders Fatigue	68.2% 15/22	68.2% 15/22
Musculoskeletal and connective tissue disorders Back Pain	9.1% 2/22	9.1% 2/22
Musculoskeletal and connective tissue disorders Pain in Extremity	4.5% 1/22	18.2% 4/22
Nervous system disorders Dizziness	40.9% 9/22	22.7% 5/22
Nervous system disorders Headache	86.4% 19/22	68.2% 15/22
Nervous system disorders Somnolence	95.5% 21/22	90.9% 20/22
Psychiatric disorders Anxiety	9.1% 2/22	4.5% 1/22
Psychiatric disorders Depression	4.5% 1/22	4.5% 1/22
Psychiatric disorders Insomnia	9.1% 2/22	0.00% 0/22
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 2/22	9.1% 2/22
Respiratory, thoracic and mediastinal disorders Nasal Congestion	68.2% 15/22	54.5% 12/22
Skin and subcutaneous tissue disorders Acne	50.0% 11/22	40.9% 9/22
Skin and subcutaneous tissue disorders Pruritus	13.6% 3/22	4.5% 1/22

Additional Information

Leggio, Lorenzo

National Institute on Alcohol Abuse and Alcoholism

Phone: +1 301 435 9398

Email: lorenzo.leggio@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place