Alcohol Dependence
Conditions
Keywords
Alcoholic
Brief summary
H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management. This study is an outpatient study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for twelve weeks.
Interventions
DRUGLY686017
50 milligrams (mg) daily by oral route for 12 weeks
DRUGPlacebo
Daily by oral route for 12 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have Alcohol Dependence. * Are men or women who are ambulatory outpatients between 21 to 65 years of age (inclusive) showing evidence of living in a non-custodial stable residence and with no plans to move during the next 5 months. * Females of childbearing potential (not surgically sterilized and between menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. They must agree to use a reliable method of birth control during the study and for 2 months following the last dose of study drug. * Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least 2 heavy drinking days per week. * Endorse abstinence or reduction in drinking as an interim goal toward abstinence.
Exclusion criteria
* Are investigator site personnel directly affiliated with this study and/or their immediate families. * Are Lilly employees. * Are currently enrolled in or discontinued within the last 30 days from a clinical trial. * Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are currently or during this study at significant risk of suffering an acute alcohol withdrawal syndrome. * Have a history of serious head injury, neoplasm or hemorrhage, prior seizure (other than a history of childhood febrile seizure), or other condition that would place the subject at increased risk for seizures. * Are taking or have taken anticonvulsant medications for seizures. * Are diagnosed with substance dependence or substance abuse other than alcohol, cannabis, nicotine, or caffeine within 12 months prior to first visit. * Are receiving medications or intensive behavioral or psychological therapy delivered by a licensed or certified alcohol treatment specialist for alcohol dependence. * Have signs and symptoms or an active illness within the past 2 weeks of first visit that meet criteria diagnosis of Major Depressive Disorder. In addition, meet criteria as diagnosis for any comorbid Axis I disorders (such as anxiety disorders, obsessive compulsive disorder (OCD), Posttraumatic stress disorder (PTSD), panic disorder, or dysthymia). * Have a positive urine drug screen for any non-prescribed substances of abuse. * Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality. * Ever had electroconvulsive therapy (ECT). * Have abnormal thyroid stimulating hormone (TSH) concentrations or are taking thyroid supplements. * Have a history of cirrhosis or laboratory evidence of hepatocellular injury. * An abnormality in serum Prothrombin time. * Are unable to make themselves available for the duration of the study or abide by study procedures and restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Heavy Drinking Days | Baseline, Weeks 4 and 8 and 12 and 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinks Per Drinking Day During a Month | Baseline and Weeks 4 and 8 and12 and 16 | 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). |
| Time to First Heavy Drinking Day | Baseline up to Week 12 | 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. |
| Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Baseline, Week 12 | 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. |
| Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12 | 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). |
| Change From Baseline in Penn Alcohol Craving Scale (PACS) | Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12 | 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. |
| Percent Days Abstinent Per Month | Baseline and Weeks 4 and 8 and 12 and 16. | 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. |
| Change From Baseline Beck Anxiety Index (BAI) Total Score | Baseline, Weeks 6 and 12 | 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. |
| Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12 | — |
| Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12 | Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption. |
| 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS) | Baseline and Week 12 | 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. |
| 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS) | Baseline and Week 12 | 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. |
| Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY686017 50 milligrams (mg) daily by oral route for 12 weeks. | 92 |
| Placebo Daily by oral route for 12 weeks. | 91 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Acute Alcohol Withdrawal | 0 | 1 |
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 10 | 13 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 8 |
| Overall Study | Withdrawal by Subject | 15 | 9 |
Baseline characteristics
| Characteristic | LY686017 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 10.5 | 43.7 years STANDARD_DEVIATION 10.8 | 43.0 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 173 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 39 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 69 Participants | 136 Participants | 67 Participants |
| Region of Enrollment United States | 92 Participants | 183 Participants | 91 Participants |
| Sex: Female, Male Female | 33 Participants | 69 Participants | 36 Participants |
| Sex: Female, Male Male | 59 Participants | 114 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 92 | 68 / 91 |
| serious Total, serious adverse events | 0 / 92 | 0 / 91 |
Outcome results
Primary
Percent Change From Baseline in Heavy Drinking Days
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.
Time frame: Baseline, 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 both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Percent Change From Baseline in Heavy Drinking Days | Week 4 | -45.63 percent of heavy drinking days | Standard Deviation 36.58 |
| LY686017 | Percent Change From Baseline in Heavy Drinking Days | Week 8 | -60.98 percent of heavy drinking days | Standard Deviation 39.25 |
| LY686017 | Percent Change From Baseline in Heavy Drinking Days | Week 12 | -68.56 percent of heavy drinking days | Standard Deviation 40.01 |
| LY686017 | Percent Change From Baseline in Heavy Drinking Days | Week 16 | -69.46 percent of heavy drinking days | Standard Deviation 35.84 |
| Placebo | Percent Change From Baseline in Heavy Drinking Days | Week 16 | -59.12 percent of heavy drinking days | Standard Deviation 40.42 |
| Placebo | Percent Change From Baseline in Heavy Drinking Days | Week 4 | -39.72 percent of heavy drinking days | Standard Deviation 36.52 |
| Placebo | Percent Change From Baseline in Heavy Drinking Days | Week 12 | -57.44 percent of heavy drinking days | Standard Deviation 42.02 |
| Placebo | Percent Change From Baseline in Heavy Drinking Days | Week 8 | -49.88 percent of heavy drinking days | Standard Deviation 48.43 |
Secondary
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
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.
Time frame: Baseline and Week 12
Population: All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | 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 |
| LY686017 | 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 |
| Placebo | 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS) | MCS: Baseline | 44.2 units on a scale | Standard Deviation 11.2 |
| Placebo | 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS) | MCS: Week 12 | 49.7 units on a scale | Standard Deviation 9.6 |
Secondary
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
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.
Time frame: Baseline and Week 12
Population: All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | 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 |
| LY686017 | 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 |
| Placebo | 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS) | PCS: Baseline | 50.2 units on a scale | Standard Deviation 8.3 |
| Placebo | 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS) | PCS: Week 12 | 51.4 units on a scale | Standard Deviation 7.5 |
Secondary
Change From Baseline Beck Anxiety Index (BAI) Total Score
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.
Time frame: Baseline, Weeks 6 and 12
Population: All randomized participants who received at least one dose of study drug and had BAI assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline Beck Anxiety Index (BAI) Total Score | Week 6 | -1.9 units on a scale | Standard Deviation 6.6 |
| LY686017 | Change From Baseline Beck Anxiety Index (BAI) Total Score | Week 12 | -1.3 units on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline Beck Anxiety Index (BAI) Total Score | Week 6 | -2.3 units on a scale | Standard Deviation 7.2 |
| Placebo | Change From Baseline Beck Anxiety Index (BAI) Total Score | Week 12 | -2.0 units on a scale | Standard Deviation 6.8 |
Secondary
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
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).
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Population: All randomized participants who received at least one dose of study drug and had AUQ assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 6 | -6.4 units on a scale | Standard Deviation 11 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 3 | -5.3 units on a scale | Standard Deviation 10.5 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 8 | -5.8 units on a scale | Standard Deviation 10.6 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 1 | -2.9 units on a scale | Standard Deviation 10.2 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 10 | -5.7 units on a scale | Standard Deviation 11 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 4 | -5.9 units on a scale | Standard Deviation 10.9 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 12 | -6.3 units on a scale | Standard Deviation 10.6 |
| LY686017 | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 2 | -5.0 units on a scale | Standard Deviation 11.5 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 12 | -9.0 units on a scale | Standard Deviation 12.5 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 1 | -2.9 units on a scale | Standard Deviation 8.8 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 3 | -6.0 units on a scale | Standard Deviation 9.6 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 4 | -5.9 units on a scale | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 6 | -8.5 units on a scale | Standard Deviation 11.7 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 8 | -7.7 units on a scale | Standard Deviation 11.8 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 10 | -7.7 units on a scale | Standard Deviation 12.7 |
| Placebo | Change From Baseline in Alcohol Urge Questionnaire (AUQ) | Week 2 | -3.6 units on a scale | Standard Deviation 11.1 |
Secondary
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
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.
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Population: All randomized participants who received at least one dose of study drug and had BDI-II assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 6 | -0.8 units on a scale | Standard Deviation 5.8 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 1 | 0.0 units on a scale | Standard Deviation 4.1 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 8 | -1.4 units on a scale | Standard Deviation 5.3 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 3 | -1.5 units on a scale | Standard Deviation 4.7 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 10 | -1.5 units on a scale | Standard Deviation 6.3 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 4 | -1.7 units on a scale | Standard Deviation 5.7 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 12 | -2.0 units on a scale | Standard Deviation 5.9 |
| LY686017 | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 2 | -0.9 units on a scale | Standard Deviation 4.1 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 12 | -3.0 units on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 1 | -1.4 units on a scale | Standard Deviation 3.6 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 2 | -1.0 units on a scale | Standard Deviation 3.9 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 4 | -2.0 units on a scale | Standard Deviation 4.5 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 6 | -1.7 units on a scale | Standard Deviation 5.5 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 8 | -3.2 units on a scale | Standard Deviation 5.9 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 10 | -2.8 units on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score | Week 3 | -1.2 units on a scale | Standard Deviation 3.9 |
Secondary
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
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.
Time frame: Baseline, Week 12
Population: All randomized participants who received at least one dose of study drug and had DrInC assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Interpersonal | -2.9 units on a scale | Standard Deviation 5.5 |
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Physical | -3.1 units on a scale | Standard Deviation 4 |
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Social | -2.0 units on a scale | Standard Deviation 3.4 |
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Impulsive | -2.5 units on a scale | Standard Deviation 4.4 |
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Intrapersonal | -4.2 units on a scale | Standard Deviation 6.7 |
| LY686017 | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Total | -16.2 units on a scale | Standard Deviation 22.2 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Intrapersonal | -3.7 units on a scale | Standard Deviation 6.2 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Interpersonal | -3.9 units on a scale | Standard Deviation 6.8 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Impulsive | -2.5 units on a scale | Standard Deviation 5.8 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Physical | -2.3 units on a scale | Standard Deviation 4.3 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Total | -16.4 units on a scale | Standard Deviation 25.5 |
| Placebo | Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale | Social | -2.1 units on a scale | Standard Deviation 4.1 |
Secondary
Change From Baseline in Penn Alcohol Craving Scale (PACS)
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.
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Population: All randomized participants who received at least one dose of study drug and had PACS assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 1 | -1.2 units on a scale | Standard Deviation 1.7 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 8 | -1.8 units on a scale | Standard Deviation 1.9 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 1 | -1.0 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 2 | -1.3 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 3 | -1.4 units on a scale | Standard Deviation 1.5 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 4 | -1.5 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 6 | -1.5 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 8 | -1.5 units on a scale | Standard Deviation 1.5 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 10 | -1.7 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 12 | -1.7 units on a scale | Standard Deviation 1.5 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 3 | -1.2 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 2 | -1.6 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 3 | -1.7 units on a scale | Standard Deviation 1.7 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 4 | -1.8 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 6 | -2.0 units on a scale | Standard Deviation 2 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 8 | -2.0 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 10 | -2.1 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 12 | -2.2 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 1 | -0.9 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 2 | -1.1 units on a scale | Standard Deviation 1.7 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 4 | -1.1 units on a scale | Standard Deviation 1.7 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 6 | -1.3 units on a scale | Standard Deviation 1.9 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 8 | -1.2 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 10 | -1.2 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 12 | -1.4 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 1 | -1.2 units on a scale | Standard Deviation 1.6 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 2 | -1.4 units on a scale | Standard Deviation 1.7 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 3 | -1.4 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 4 | -1.6 units on a scale | Standard Deviation 1.9 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 6 | -1.6 units on a scale | Standard Deviation 2 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 10 | -1.7 units on a scale | Standard Deviation 1.9 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 12 | -1.9 units on a scale | Standard Deviation 1.8 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 1 | -1.0 units on a scale | Standard Deviation 1.2 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 2 | -1.2 units on a scale | Standard Deviation 1.3 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 3 | -1.4 units on a scale | Standard Deviation 1.3 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 4 | -1.5 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 6 | -1.7 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 8 | -1.7 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 10 | -1.6 units on a scale | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 12 | -1.8 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 8 | -1.4 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 3 | -0.7 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 4 | -0.8 units on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 8 | -1.5 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 10 | -1.5 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 1 | -0.6 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 6 | -0.9 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 2 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 4 | -1.2 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 3 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 8 | -1.0 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 4 | -1.3 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 12 | -1.4 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 6 | -1.3 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 10 | -1.0 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 8 | -1.3 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 12 | -1.5 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 10 | -1.3 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 12 | -1.0 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Frequency: Week 12 | -1.4 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 1 | -0.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 1 | -0.7 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 1 | -0.9 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 2 | -1.0 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 6 | -1.4 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 3 | -1.3 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 2 | -1.0 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 4 | -1.4 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 2 | -0.9 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 6 | -1.6 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 3 | -1.2 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 8 | -1.5 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 10 | -1.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 10 | -1.6 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 4 | -1.3 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Intensity: Week 12 | -1.8 units on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Craving: Week 3 | -1.1 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 1 | -0.4 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Resistance: Week 6 | -1.5 units on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Penn Alcohol Craving Scale (PACS) | Duration: Week 2 | -0.6 units on a scale | Standard Deviation 1.7 |
Secondary
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Population: All randomized participants who received at least one dose of study drug and had CDT assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 1 | -0.1 percent CDT | Standard Deviation 0.5 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 2 | -0.2 percent CDT | Standard Deviation 0.7 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 3 | -0.1 percent CDT | Standard Deviation 0.9 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 4 | -0.2 percent CDT | Standard Deviation 0.9 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 6 | -0.1 percent CDT | Standard Deviation 1.2 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 8 | -0.0 percent CDT | Standard Deviation 1.4 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 10 | -0.1 percent CDT | Standard Deviation 1.5 |
| LY686017 | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 12 | -0.0 percent CDT | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 12 | 0.1 percent CDT | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 1 | -0.0 percent CDT | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 6 | 0.2 percent CDT | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 2 | -0.1 percent CDT | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 10 | 0.1 percent CDT | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 3 | -0.0 percent CDT | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 8 | 0.1 percent CDT | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) | Week 4 | 0.1 percent CDT | Standard Deviation 1.5 |
Secondary
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Time frame: Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12
Population: All randomized participants who received at least one dose of study drug and had GGT assessed at both baseline and post-baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 4 | -8.0 units per liter (U/L) | Standard Deviation 27.3 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 1 | -5.4 units per liter (U/L) | Standard Deviation 18.8 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 2 | -6.6 units per liter (U/L) | Standard Deviation 20.2 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 3 | -9.7 units per liter (U/L) | Standard Deviation 26.1 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 6 | -10.9 units per liter (U/L) | Standard Deviation 33.4 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 8 | -10.9 units per liter (U/L) | Standard Deviation 36.2 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 10 | -12.2 units per liter (U/L) | Standard Deviation 35.8 |
| LY686017 | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 12 | -11.5 units per liter (U/L) | Standard Deviation 42.6 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 12 | -2.1 units per liter (U/L) | Standard Deviation 20.1 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 6 | -4.1 units per liter (U/L) | Standard Deviation 17.8 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 1 | -1.3 units per liter (U/L) | Standard Deviation 9.4 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 10 | -4.0 units per liter (U/L) | Standard Deviation 26.4 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 2 | -2.1 units per liter (U/L) | Standard Deviation 12.9 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 8 | -3.4 units per liter (U/L) | Standard Deviation 20.6 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 3 | -3.7 units per liter (U/L) | Standard Deviation 13.7 |
| Placebo | Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) | Week 4 | -3.0 units per liter (U/L) | Standard Deviation 14.2 |
Secondary
Number of Drinks Per Drinking Day During a Month
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).
Time frame: Baseline and Weeks 4 and 8 and12 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Number of Drinks Per Drinking Day During a Month | Week 4 | 3.92 drinks/drinking day/month | Standard Deviation 2.37 |
| LY686017 | Number of Drinks Per Drinking Day During a Month | Week 12 | 2.32 drinks/drinking day/month | Standard Deviation 2.25 |
| LY686017 | Number of Drinks Per Drinking Day During a Month | Week 8 | 3.03 drinks/drinking day/month | Standard Deviation 2.52 |
| LY686017 | Number of Drinks Per Drinking Day During a Month | Week 16 | 2.31 drinks/drinking day/month | Standard Deviation 2.83 |
| LY686017 | Number of Drinks Per Drinking Day During a Month | Baseline | 7.04 drinks/drinking day/month | Standard Deviation 3.07 |
| Placebo | Number of Drinks Per Drinking Day During a Month | Week 16 | 2.92 drinks/drinking day/month | Standard Deviation 3.38 |
| Placebo | Number of Drinks Per Drinking Day During a Month | Baseline | 7.35 drinks/drinking day/month | Standard Deviation 3.78 |
| Placebo | Number of Drinks Per Drinking Day During a Month | Week 4 | 4.69 drinks/drinking day/month | Standard Deviation 3.64 |
| Placebo | Number of Drinks Per Drinking Day During a Month | Week 8 | 3.36 drinks/drinking day/month | Standard Deviation 3.31 |
| Placebo | Number of Drinks Per Drinking Day During a Month | Week 12 | 2.99 drinks/drinking day/month | Standard Deviation 3.7 |
Secondary
Percent Days Abstinent Per Month
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY686017 | Percent Days Abstinent Per Month | Week 4 | 30.28 percentage days abstinent per month | Standard Deviation 28.13 |
| LY686017 | Percent Days Abstinent Per Month | Week 12 | 51.43 percentage days abstinent per month | Standard Deviation 32.59 |
| LY686017 | Percent Days Abstinent Per Month | Week 8 | 40.73 percentage days abstinent per month | Standard Deviation 32.97 |
| LY686017 | Percent Days Abstinent Per Month | Week 16 | 52.92 percentage days abstinent per month | Standard Deviation 32.07 |
| LY686017 | Percent Days Abstinent Per Month | Baseline | 11.63 percentage days abstinent per month | Standard Deviation 12.55 |
| Placebo | Percent Days Abstinent Per Month | Week 16 | 44.63 percentage days abstinent per month | Standard Deviation 36.84 |
| Placebo | Percent Days Abstinent Per Month | Baseline | 14.54 percentage days abstinent per month | Standard Deviation 17.32 |
| Placebo | Percent Days Abstinent Per Month | Week 4 | 29.44 percentage days abstinent per month | Standard Deviation 26.56 |
| Placebo | Percent Days Abstinent Per Month | Week 8 | 40.07 percentage days abstinent per month | Standard Deviation 33.68 |
| Placebo | Percent Days Abstinent Per Month | Week 12 | 45.81 percentage days abstinent per month | Standard Deviation 34.74 |
Secondary
Time to First Heavy Drinking Day
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.
Time frame: Baseline up to Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LY686017 | Time to First Heavy Drinking Day | 7.3 days | Standard Deviation 16.8 |
| Placebo | Time to First Heavy Drinking Day | 8.0 days | Standard Deviation 22.2 |