Trial Outcomes & Findings for A Study in the Treatment of Alcohol Dependence. (NCT NCT00805441)
NCT ID: NCT00805441
Last Updated: 2019-09-17
Results Overview
The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
COMPLETED
PHASE2
190 participants
Baseline, Weeks 4 and 8 and 12 and 16
2019-09-17
Participant Flow
Participant milestones
| Measure |
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
96
|
|
Overall Study
Full Analysis Set (FAS)
|
92
|
91
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
34
|
36
|
Reasons for withdrawal
| Measure |
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
4
|
8
|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
|
Overall Study
Withdrawal by Subject
|
15
|
9
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Acute Alcohol Withdrawal
|
0
|
1
|
Baseline Characteristics
A Study in the Treatment of Alcohol Dependence.
Baseline characteristics by cohort
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=91 Participants
Daily by oral route for 12 weeks.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
173 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4 and 8 and 12 and 16Population: All randomized participants who received at least one dose of study drug and had daily drinking assessed at both baseline and post-baseline.
The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
Outcome measures
| Measure |
LY686017
n=91 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=90 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Heavy Drinking Days
Week 4
|
-45.63 percent of heavy drinking days
Standard Deviation 36.58
|
-39.72 percent of heavy drinking days
Standard Deviation 36.52
|
|
Percent Change From Baseline in Heavy Drinking Days
Week 8
|
-60.98 percent of heavy drinking days
Standard Deviation 39.25
|
-49.88 percent of heavy drinking days
Standard Deviation 48.43
|
|
Percent Change From Baseline in Heavy Drinking Days
Week 12
|
-68.56 percent of heavy drinking days
Standard Deviation 40.01
|
-57.44 percent of heavy drinking days
Standard Deviation 42.02
|
|
Percent Change From Baseline in Heavy Drinking Days
Week 16
|
-69.46 percent of heavy drinking days
Standard Deviation 35.84
|
-59.12 percent of heavy drinking days
Standard Deviation 40.42
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4 and 8 and 12 and 16.Population: All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.
The Alcohol Timeline Followback (TLFB) is used in calculating the percentage of days abstinent (days where no alcoholic drinks were consumed). The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Percentage days per month= (number of days where no alcoholic beverages were consumed/number of days in a month)\*100.
Outcome measures
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=91 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Percent Days Abstinent Per Month
Baseline
|
11.63 percentage days abstinent per month
Standard Deviation 12.55
|
14.54 percentage days abstinent per month
Standard Deviation 17.32
|
|
Percent Days Abstinent Per Month
Week 4
|
30.28 percentage days abstinent per month
Standard Deviation 28.13
|
29.44 percentage days abstinent per month
Standard Deviation 26.56
|
|
Percent Days Abstinent Per Month
Week 8
|
40.73 percentage days abstinent per month
Standard Deviation 32.97
|
40.07 percentage days abstinent per month
Standard Deviation 33.68
|
|
Percent Days Abstinent Per Month
Week 12
|
51.43 percentage days abstinent per month
Standard Deviation 32.59
|
45.81 percentage days abstinent per month
Standard Deviation 34.74
|
|
Percent Days Abstinent Per Month
Week 16
|
52.92 percentage days abstinent per month
Standard Deviation 32.07
|
44.63 percentage days abstinent per month
Standard Deviation 36.84
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4 and 8 and12 and 16Population: All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.
The Alcohol Timeline Followback (TLFB) is used in calculating the number of drinks per drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv).
Outcome measures
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=91 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Number of Drinks Per Drinking Day During a Month
Week 12
|
2.32 drinks/drinking day/month
Standard Deviation 2.25
|
2.99 drinks/drinking day/month
Standard Deviation 3.70
|
|
Number of Drinks Per Drinking Day During a Month
Baseline
|
7.04 drinks/drinking day/month
Standard Deviation 3.07
|
7.35 drinks/drinking day/month
Standard Deviation 3.78
|
|
Number of Drinks Per Drinking Day During a Month
Week 4
|
3.92 drinks/drinking day/month
Standard Deviation 2.37
|
4.69 drinks/drinking day/month
Standard Deviation 3.64
|
|
Number of Drinks Per Drinking Day During a Month
Week 8
|
3.03 drinks/drinking day/month
Standard Deviation 2.52
|
3.36 drinks/drinking day/month
Standard Deviation 3.31
|
|
Number of Drinks Per Drinking Day During a Month
Week 16
|
2.31 drinks/drinking day/month
Standard Deviation 2.83
|
2.92 drinks/drinking day/month
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: All randomized participants who received at least one dose of study drug and had daily drinking assessed. The numbers of participants censored are 4 for LY686017 group and 3 for placebo group.
The Alcohol Timeline Followback (TLFB) is used to assess the time to first heavy drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. Those who did not drink are considered to be "censored."
Outcome measures
| Measure |
LY686017
n=91 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=90 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Time to First Heavy Drinking Day
|
7.3 days
Standard Deviation 16.8
|
8.0 days
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of study drug and had DrInC assessed at both baseline and post-baseline.
DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. All items for the DrInC are scored from 0-3 with higher scores indicating worse adverse consequences. Interpersonal subscale (10 items: scores range from 0-30) measures the impact of drinking on the participants' relationships. Physical subscale (8 items: scores range from 0-24) measures adverse physical states resulting from excessive drinking. Social subscale (7 items: scores range from 0-21) measures role fulfillment. Impulsive subscale (12 items: scores range from 0-36) measures sequelae of over drinking. Intrapersonal subscale (8 items: scores range from 0-24) measures subjective perceptions that may not be readily observable by others. Total scores range from 0-150, with higher scores indicating greater severity of symptoms.
Outcome measures
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=91 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Interpersonal
|
-2.9 units on a scale
Standard Deviation 5.5
|
-3.9 units on a scale
Standard Deviation 6.8
|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Physical
|
-3.1 units on a scale
Standard Deviation 4.0
|
-2.3 units on a scale
Standard Deviation 4.3
|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Social
|
-2.0 units on a scale
Standard Deviation 3.4
|
-2.1 units on a scale
Standard Deviation 4.1
|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Impulsive
|
-2.5 units on a scale
Standard Deviation 4.4
|
-2.5 units on a scale
Standard Deviation 5.8
|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Intrapersonal
|
-4.2 units on a scale
Standard Deviation 6.7
|
-3.7 units on a scale
Standard Deviation 6.2
|
|
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Total
|
-16.2 units on a scale
Standard Deviation 22.2
|
-16.4 units on a scale
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12Population: All randomized participants who received at least one dose of study drug and had AUQ assessed at both baseline and post-baseline.
AUQ measures participant's feeling and thoughts about drinking, and uses a 7 point (1-7) Likert scale for each of 8 items (questions). Scores range from 8 (less urge to drink) to 56 (more urge to drink).
Outcome measures
| Measure |
LY686017
n=91 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=90 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 1
|
-2.9 units on a scale
Standard Deviation 10.2
|
-2.9 units on a scale
Standard Deviation 8.8
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 2
|
-5.0 units on a scale
Standard Deviation 11.5
|
-3.6 units on a scale
Standard Deviation 11.1
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 3
|
-5.3 units on a scale
Standard Deviation 10.5
|
-6.0 units on a scale
Standard Deviation 9.6
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 4
|
-5.9 units on a scale
Standard Deviation 10.9
|
-5.9 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 6
|
-6.4 units on a scale
Standard Deviation 11.0
|
-8.5 units on a scale
Standard Deviation 11.7
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 8
|
-5.8 units on a scale
Standard Deviation 10.6
|
-7.7 units on a scale
Standard Deviation 11.8
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 10
|
-5.7 units on a scale
Standard Deviation 11.0
|
-7.7 units on a scale
Standard Deviation 12.7
|
|
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Week 12
|
-6.3 units on a scale
Standard Deviation 10.6
|
-9.0 units on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12Population: All randomized participants who received at least one dose of study drug and had PACS assessed at both baseline and post-baseline.
PACS is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, ability to resist drinking and craving. Each item ranges from 0-6 with 6 indicating worse symptoms.
Outcome measures
| Measure |
LY686017
n=90 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=90 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 1
|
-1.0 units on a scale
Standard Deviation 1.2
|
-0.6 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 2
|
-1.2 units on a scale
Standard Deviation 1.3
|
-0.9 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 1
|
-1.0 units on a scale
Standard Deviation 1.4
|
-0.6 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 2
|
-1.3 units on a scale
Standard Deviation 1.4
|
-1.0 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 3
|
-1.4 units on a scale
Standard Deviation 1.5
|
-1.0 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 4
|
-1.5 units on a scale
Standard Deviation 1.6
|
-1.3 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 6
|
-1.5 units on a scale
Standard Deviation 1.6
|
-1.3 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 8
|
-1.5 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 10
|
-1.7 units on a scale
Standard Deviation 1.6
|
-1.3 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Frequency: Week 12
|
-1.7 units on a scale
Standard Deviation 1.5
|
-1.4 units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 1
|
-1.2 units on a scale
Standard Deviation 1.7
|
-0.7 units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 2
|
-1.6 units on a scale
Standard Deviation 1.6
|
-1.0 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 3
|
-1.7 units on a scale
Standard Deviation 1.7
|
-1.3 units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 4
|
-1.8 units on a scale
Standard Deviation 1.8
|
-1.4 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 6
|
-2.0 units on a scale
Standard Deviation 2.0
|
-1.6 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 8
|
-2.0 units on a scale
Standard Deviation 1.8
|
-1.5 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 10
|
-2.1 units on a scale
Standard Deviation 1.8
|
-1.6 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Intensity: Week 12
|
-2.2 units on a scale
Standard Deviation 1.6
|
-1.8 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 1
|
-0.9 units on a scale
Standard Deviation 1.6
|
-0.4 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 2
|
-1.1 units on a scale
Standard Deviation 1.7
|
-0.6 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 3
|
-1.2 units on a scale
Standard Deviation 1.8
|
-0.7 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 4
|
-1.1 units on a scale
Standard Deviation 1.7
|
-0.8 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 6
|
-1.3 units on a scale
Standard Deviation 1.9
|
-0.9 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 8
|
-1.2 units on a scale
Standard Deviation 1.6
|
-1.0 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 10
|
-1.2 units on a scale
Standard Deviation 1.8
|
-1.0 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Duration: Week 12
|
-1.4 units on a scale
Standard Deviation 1.8
|
-1.0 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 1
|
-1.2 units on a scale
Standard Deviation 1.6
|
-0.9 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 2
|
-1.4 units on a scale
Standard Deviation 1.7
|
-1.0 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 3
|
-1.4 units on a scale
Standard Deviation 1.8
|
-1.2 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 4
|
-1.6 units on a scale
Standard Deviation 1.9
|
-1.3 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 6
|
-1.6 units on a scale
Standard Deviation 2.0
|
-1.5 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 8
|
-1.8 units on a scale
Standard Deviation 1.9
|
-1.5 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 10
|
-1.7 units on a scale
Standard Deviation 1.9
|
-1.5 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Resistance: Week 12
|
-1.9 units on a scale
Standard Deviation 1.8
|
-1.4 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 3
|
-1.4 units on a scale
Standard Deviation 1.3
|
-1.1 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 4
|
-1.5 units on a scale
Standard Deviation 1.4
|
-1.2 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 6
|
-1.7 units on a scale
Standard Deviation 1.4
|
-1.4 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 8
|
-1.7 units on a scale
Standard Deviation 1.4
|
-1.4 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 10
|
-1.6 units on a scale
Standard Deviation 1.4
|
-1.4 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Craving: Week 12
|
-1.8 units on a scale
Standard Deviation 1.4
|
-1.5 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12Population: All randomized participants who received at least one dose of study drug and had BDI-II assessed at both baseline and post-baseline.
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. There is a 4-point scale for each item ranging from 0 (no depression) to 3 (very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression.
Outcome measures
| Measure |
LY686017
n=91 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=90 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 1
|
0.0 units on a scale
Standard Deviation 4.1
|
-1.4 units on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 2
|
-0.9 units on a scale
Standard Deviation 4.1
|
-1.0 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 3
|
-1.5 units on a scale
Standard Deviation 4.7
|
-1.2 units on a scale
Standard Deviation 3.9
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 4
|
-1.7 units on a scale
Standard Deviation 5.7
|
-2.0 units on a scale
Standard Deviation 4.5
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 6
|
-0.8 units on a scale
Standard Deviation 5.8
|
-1.7 units on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 8
|
-1.4 units on a scale
Standard Deviation 5.3
|
-3.2 units on a scale
Standard Deviation 5.9
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 10
|
-1.5 units on a scale
Standard Deviation 6.3
|
-2.8 units on a scale
Standard Deviation 6.7
|
|
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Week 12
|
-2.0 units on a scale
Standard Deviation 5.9
|
-3.0 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 6 and 12Population: All randomized participants who received at least one dose of study drug and had BAI assessed at both baseline and post-baseline.
BAI is a 21-item participant-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0= not present; 3= present in the extreme). Total scores range from 0 to 63. Higher total scores indicate greater severity of anxiety symptoms.
Outcome measures
| Measure |
LY686017
n=75 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=73 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline Beck Anxiety Index (BAI) Total Score
Week 6
|
-1.9 units on a scale
Standard Deviation 6.6
|
-2.3 units on a scale
Standard Deviation 7.2
|
|
Change From Baseline Beck Anxiety Index (BAI) Total Score
Week 12
|
-1.3 units on a scale
Standard Deviation 6.7
|
-2.0 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12Population: All randomized participants who received at least one dose of study drug and had GGT assessed at both baseline and post-baseline.
Outcome measures
| Measure |
LY686017
n=91 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=89 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 1
|
-5.4 units per liter (U/L)
Standard Deviation 18.8
|
-1.3 units per liter (U/L)
Standard Deviation 9.4
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 2
|
-6.6 units per liter (U/L)
Standard Deviation 20.2
|
-2.1 units per liter (U/L)
Standard Deviation 12.9
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 3
|
-9.7 units per liter (U/L)
Standard Deviation 26.1
|
-3.7 units per liter (U/L)
Standard Deviation 13.7
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 4
|
-8.0 units per liter (U/L)
Standard Deviation 27.3
|
-3.0 units per liter (U/L)
Standard Deviation 14.2
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 6
|
-10.9 units per liter (U/L)
Standard Deviation 33.4
|
-4.1 units per liter (U/L)
Standard Deviation 17.8
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 8
|
-10.9 units per liter (U/L)
Standard Deviation 36.2
|
-3.4 units per liter (U/L)
Standard Deviation 20.6
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 10
|
-12.2 units per liter (U/L)
Standard Deviation 35.8
|
-4.0 units per liter (U/L)
Standard Deviation 26.4
|
|
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Week 12
|
-11.5 units per liter (U/L)
Standard Deviation 42.6
|
-2.1 units per liter (U/L)
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12Population: All randomized participants who received at least one dose of study drug and had CDT assessed at both baseline and post-baseline.
Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.
Outcome measures
| Measure |
LY686017
n=82 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=83 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 1
|
-0.1 percent CDT
Standard Deviation 0.5
|
-0.0 percent CDT
Standard Deviation 0.7
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 2
|
-0.2 percent CDT
Standard Deviation 0.7
|
-0.1 percent CDT
Standard Deviation 0.8
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 3
|
-0.1 percent CDT
Standard Deviation 0.9
|
-0.0 percent CDT
Standard Deviation 1.2
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 4
|
-0.2 percent CDT
Standard Deviation 0.9
|
0.1 percent CDT
Standard Deviation 1.5
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 6
|
-0.1 percent CDT
Standard Deviation 1.2
|
0.2 percent CDT
Standard Deviation 1.5
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 8
|
-0.0 percent CDT
Standard Deviation 1.4
|
0.1 percent CDT
Standard Deviation 1.3
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 10
|
-0.1 percent CDT
Standard Deviation 1.5
|
0.1 percent CDT
Standard Deviation 0.8
|
|
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Week 12
|
-0.0 percent CDT
Standard Deviation 1.2
|
0.1 percent CDT
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.
Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing \[physical component score (PCS)\] and mental wellbeing \[mental component score (MCS)\]. The PCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.
Outcome measures
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=88 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
PCS: Baseline
|
49.2 units on a scale
Standard Deviation 8.7
|
50.2 units on a scale
Standard Deviation 8.3
|
|
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
PCS: Week 12
|
53.0 units on a scale
Standard Deviation 8.6
|
51.4 units on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.
Short Form 12 (SF-12) is a 12-item assessment used to measure participant's physical wellbeing \[physical component score (PCS)\] and mental wellbeing \[mental component score (MCS)\]. The MCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.
Outcome measures
| Measure |
LY686017
n=92 Participants
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=88 Participants
Daily by oral route for 12 weeks.
|
|---|---|---|
|
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
MCS: Baseline
|
45.7 units on a scale
Standard Deviation 11.6
|
44.2 units on a scale
Standard Deviation 11.2
|
|
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
MCS: Week 12
|
48.5 units on a scale
Standard Deviation 10.0
|
49.7 units on a scale
Standard Deviation 9.6
|
Adverse Events
LY686017
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY686017
n=92 participants at risk
50 milligrams (mg) daily by oral route for 12 weeks.
|
Placebo
n=91 participants at risk
Daily by oral route for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
5/92 • Number of events 6
|
3.3%
3/91 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
9.8%
9/92 • Number of events 9
|
6.6%
6/91 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
7.6%
7/92 • Number of events 8
|
15.4%
14/91 • Number of events 17
|
|
General disorders
Fatigue
|
8.7%
8/92 • Number of events 9
|
7.7%
7/91 • Number of events 8
|
|
General disorders
Irritability
|
0.00%
0/92
|
4.4%
4/91 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/92 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
10/92 • Number of events 11
|
15.4%
14/91 • Number of events 14
|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
4/92 • Number of events 4
|
2.2%
2/91 • Number of events 2
|
|
Metabolism and nutrition disorders
Increased appetite
|
4.3%
4/92 • Number of events 4
|
2.2%
2/91 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
5/92 • Number of events 7
|
4.4%
4/91 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
7.6%
7/92 • Number of events 7
|
3.3%
3/91 • Number of events 3
|
|
Nervous system disorders
Headache
|
6.5%
6/92 • Number of events 7
|
9.9%
9/91 • Number of events 13
|
|
Nervous system disorders
Somnolence
|
7.6%
7/92 • Number of events 7
|
0.00%
0/91
|
|
Psychiatric disorders
Insomnia
|
5.4%
5/92 • Number of events 5
|
3.3%
3/91 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60