A Study in the Treatment of Alcohol Dependence.

ID: NCT00805441
Status: Completed
Phase: Phase 2
Start Date: December 01, 2008
First Submitted: December 05, 2008
Last Updated: February 12, 2018
Results: Available
Success Rate: 63%
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company
Location: United States
Conditions: Alcohol Dependence
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Alcohol Dependence
Drug: LY686017
Other Names
Drug: Placebo
Other Names
Phase 2

Tracking Information

First Submitted DateDecember 05, 2008
Last Update Posted DateFebruary 12, 2018
Start DateDecember 01, 2008
Actual Completion DateJuly 01, 2009
Primary Completion DateJuly 01, 2009
Results First Submitted DateOctober 21, 2017
Received Results Disposit DateMay 27, 2010

Current Primary Outcome Measures

  • Percent Change From Baseline in Heavy Drinking Days [Time Frame: 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.

Original Primary Outcome Measures

  • 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.

Current Secondary Outcome Measures

  • Percent Days Abstinent Per Month [Time Frame: 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.

  • Number of Drinks Per Drinking Day During a Month [Time Frame: 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 [Time Frame: 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 [Time Frame: 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) [Time Frame: 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) [Time Frame: 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.

  • Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score [Time Frame: 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.

  • Change From Baseline Beck Anxiety Index (BAI) Total Score [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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) [Time Frame: 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.

Original Secondary Outcome Measures

  • 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.

  • 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.

  • 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.

  • Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)

  • 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.

  • 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.

  • 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.

  • 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).

  • 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 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."

  • 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).

  • 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.

Study Design

Brief TitleA Study in the Treatment of Alcohol Dependence.
Official TitleA Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
190
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Alcohol Dependence
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: LY686017

50 milligrams (mg) daily by oral route for 12 weeks

Other Names
Drug: Placebo

Daily by oral route for 12 weeks

Other Names
Study Groups/Cohorts
Placebo

LY686017

Study Arms
Experimental LY686017
Drug : LY686017
50 milligrams (mg) daily by oral route for 12 weeks

Placebo Comparator Placebo
Drug : Placebo
Daily by oral route for 12 weeks

Arm Intervention/Treatment
Experimental LY686017
Drug : LY686017
Placebo Comparator Placebo
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment190
Completion DateJuly 01, 2009
Eligibility Criteria: 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.
GenderAll
Age21 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00805441
Other Study ID Numbers
12422
H8R-MC-HJAQ
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
Not Available
Investigators
Study Director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Participant Flow: Overall

LY686017Placebo
9291
Started9496
Completed6060
Not Completed3436
Acute Alcohol Withdrawal01
Adverse Event52
Lack of Efficacy02
Lost to Follow-up1013
Physician Decision01
Protocol Violation48
Withdrawal by Subject159

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set: all randomized participants who received ≥1 dose study drug and contributed to post-baseline data.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.
Total
Total of all reporting groups

Baseline Measures

LY686017PlaceboTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
9291183
9291183
Age
Units: years - Mean (Standard Deviation)
Participants Analyzed
9291183
44.3 (10.5)43.0 (11.1)43.7 (10.8)
Sex: Female, Male
Units: Participants - Count of Participants
Participants Analyzed
9291183
Female333669
Male5955114
Ethnicity (NIH/OMB)
Units: Participants - Count of Participants
Participants Analyzed
9291183
Hispanic or Latino6410
Not Hispanic or Latino8687173
Unknown or Not Reported000
Race (NIH/OMB)
Units: Participants - Count of Participants
Participants Analyzed
9291183
American Indian or Alaska Native101
Asian101
Black or African American182139
More than one race000
Native Hawaiian or Other Pacific Islander000
Unknown or Not Reported336
White6967136
Region of Enrollment
Units: Participants - Count of Participants
Participants Analyzed
9291183
United States9291183

Outcome Measures

1. Primary: Percent Change From Baseline in Heavy Drinking Days

Measure Type
Primary
Measure Title
Percent Change From Baseline in Heavy Drinking Days
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had daily drinking assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9190
Percent Change From Baseline in Heavy Drinking Days
Units: percent of heavy drinking days - Mean (Standard Deviation)
Week 12-68.56 (40.01)-57.44 (42.02)
Week 16-69.46 (35.84)-59.12 (40.42)
Week 4-45.63 (36.58)-39.72 (36.52)
Week 8-60.98 (39.25)-49.88 (48.43)

2. Secondary: Percent Days Abstinent Per Month

Measure Type
Secondary
Measure Title
Percent Days Abstinent Per Month
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9291
Percent Days Abstinent Per Month
Units: percentage days abstinent per month - Mean (Standard Deviation)
Baseline11.63 (12.55)14.54 (17.32)
Week 1251.43 (32.59)45.81 (34.74)
Week 1652.92 (32.07)44.63 (36.84)
Week 430.28 (28.13)29.44 (26.56)
Week 840.73 (32.97)40.07 (33.68)

3. Secondary: Number of Drinks Per Drinking Day During a Month

Measure Type
Secondary
Measure Title
Number of Drinks Per Drinking Day During a Month
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9291
Number of Drinks Per Drinking Day During a Month
Units: drinks/drinking day/month - Mean (Standard Deviation)
Baseline7.04 (3.07)7.35 (3.78)
Week 122.32 (2.25)2.99 (3.70)
Week 162.31 (2.83)2.92 (3.38)
Week 43.92 (2.37)4.69 (3.64)
Week 83.03 (2.52)3.36 (3.31)

4. Secondary: Time to First Heavy Drinking Day

Measure Type
Secondary
Measure Title
Time to First Heavy Drinking Day
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9190
Time to First Heavy Drinking Day
Units: days - Mean (Standard Deviation)
7.3 (16.8)8.0 (22.2)

5. Secondary: Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale

Measure Type
Secondary
Measure Title
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had DrInC assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9291
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Units: units on a scale - Mean (Standard Deviation)
Impulsive-2.5 (4.4)-2.5 (5.8)
Interpersonal-2.9 (5.5)-3.9 (6.8)
Intrapersonal-4.2 (6.7)-3.7 (6.2)
Physical-3.1 (4.0)-2.3 (4.3)
Social-2.0 (3.4)-2.1 (4.1)
Total-16.2 (22.2)-16.4 (25.5)

6. Secondary: Change From Baseline in Alcohol Urge Questionnaire (AUQ)

Measure Type
Secondary
Measure Title
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had AUQ assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9190
Change From Baseline in Alcohol Urge Questionnaire (AUQ)
Units: units on a scale - Mean (Standard Deviation)
Week 1-2.9 (10.2)-2.9 (8.8)
Week 10-2.9 (10.2)0-2.9 (8.8)0
Week 12-2.9 (10.2)2-2.9 (8.8)2
Week 2-5.0 (11.5)-3.6 (11.1)
Week 3-5.3 (10.5)-6.0 (9.6)
Week 4-5.9 (10.9)-5.9 (10.1)
Week 6-6.4 (11.0)-8.5 (11.7)
Week 8-5.8 (10.6)-7.7 (11.8)

7. Secondary: Change From Baseline in Penn Alcohol Craving Scale (PACS)

Measure Type
Secondary
Measure Title
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had PACS assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9090
Change From Baseline in Penn Alcohol Craving Scale (PACS)
Units: units on a scale - Mean (Standard Deviation)
Craving: Week 1-1.0 (1.2)-0.6 (1.2)
Craving: Week 10-1.0 (1.2)0-0.6 (1.2)0
Craving: Week 12-1.0 (1.2)2-0.6 (1.2)2
Craving: Week 2-1.2 (1.3)-0.9 (1.2)
Craving: Week 3-1.4 (1.3)-1.1 (1.2)
Craving: Week 4-1.5 (1.4)-1.2 (1.2)
Craving: Week 6-1.7 (1.4)-1.4 (1.3)
Craving: Week 8-1.7 (1.4)-1.4 (1.3)
Duration: Week 1-0.9 (1.6)-0.4 (1.6)
Duration: Week 10-0.9 (1.6)0-0.4 (1.6)0
Duration: Week 12-0.9 (1.6)2-0.4 (1.6)2
Duration: Week 2-1.1 (1.7)-0.6 (1.7)
Duration: Week 3-1.2 (1.8)-0.7 (1.5)
Duration: Week 4-1.1 (1.7)-0.8 (1.5)
Duration: Week 6-1.3 (1.9)-0.9 (1.6)
Duration: Week 8-1.2 (1.6)-1.0 (1.8)
Frequency: Week 1-1.0 (1.4)-0.6 (1.3)
Frequency: Week 10-1.0 (1.4)0-0.6 (1.3)0
Frequency: Week 12-1.0 (1.4)2-0.6 (1.3)2
Frequency: Week 2-1.3 (1.4)-1.0 (1.3)
Frequency: Week 3-1.4 (1.5)-1.0 (1.3)
Frequency: Week 4-1.5 (1.6)-1.3 (1.3)
Frequency: Week 6-1.5 (1.6)-1.3 (1.3)
Frequency: Week 8-1.5 (1.5)-1.3 (1.4)
Intensity: Week 1-1.2 (1.7)-0.7 (1.4)
Intensity: Week 10-1.2 (1.7)0-0.7 (1.4)0
Intensity: Week 12-1.2 (1.7)2-0.7 (1.4)2
Intensity: Week 2-1.6 (1.6)-1.0 (1.3)
Intensity: Week 3-1.7 (1.7)-1.3 (1.4)
Intensity: Week 4-1.8 (1.8)-1.4 (1.6)
Intensity: Week 6-2.0 (2.0)-1.6 (1.7)
Intensity: Week 8-2.0 (1.8)-1.5 (1.7)
Resistance: Week 1-1.2 (1.6)-0.9 (1.7)
Resistance: Week 10-1.2 (1.6)0-0.9 (1.7)0
Resistance: Week 12-1.2 (1.6)2-0.9 (1.7)2
Resistance: Week 2-1.4 (1.7)-1.0 (1.8)
Resistance: Week 3-1.4 (1.8)-1.2 (1.6)
Resistance: Week 4-1.6 (1.9)-1.3 (1.7)
Resistance: Week 6-1.6 (2.0)-1.5 (2.0)
Resistance: Week 8-1.8 (1.9)-1.5 (1.9)

8. Secondary: Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score

Measure Type
Secondary
Measure Title
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had BDI-II assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9190
Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score
Units: units on a scale - Mean (Standard Deviation)
Week 10.0 (4.1)-1.4 (3.6)
Week 100.0 (4.1)0-1.4 (3.6)0
Week 120.0 (4.1)2-1.4 (3.6)2
Week 2-0.9 (4.1)-1.0 (3.9)
Week 3-1.5 (4.7)-1.2 (3.9)
Week 4-1.7 (5.7)-2.0 (4.5)
Week 6-0.8 (5.8)-1.7 (5.5)
Week 8-1.4 (5.3)-3.2 (5.9)

9. Secondary: Change From Baseline Beck Anxiety Index (BAI) Total Score

Measure Type
Secondary
Measure Title
Change From Baseline Beck Anxiety Index (BAI) Total Score
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had BAI assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
7573
Change From Baseline Beck Anxiety Index (BAI) Total Score
Units: units on a scale - Mean (Standard Deviation)
Week 12-1.3 (6.7)-2.0 (6.8)
Week 6-1.9 (6.6)-2.3 (7.2)

10. Secondary: Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)

Measure Type
Secondary
Measure Title
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Measure Description
Not Available
Time Frame
Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had GGT assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9189
Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)
Units: units per liter (U/L) - Mean (Standard Deviation)
Week 1-5.4 (18.8)-1.3 (9.4)
Week 10-5.4 (18.8)0-1.3 (9.4)0
Week 12-5.4 (18.8)2-1.3 (9.4)2
Week 2-6.6 (20.2)-2.1 (12.9)
Week 3-9.7 (26.1)-3.7 (13.7)
Week 4-8.0 (27.3)-3.0 (14.2)
Week 6-10.9 (33.4)-4.1 (17.8)
Week 8-10.9 (36.2)-3.4 (20.6)

11. Secondary: Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)

Measure Type
Secondary
Measure Title
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had CDT assessed at both baseline and post-baseline.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
8283
Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)
Units: percent CDT - Mean (Standard Deviation)
Week 1-0.1 (0.5)-0.0 (0.7)
Week 10-0.1 (0.5)0-0.0 (0.7)0
Week 12-0.1 (0.5)2-0.0 (0.7)2
Week 2-0.2 (0.7)-0.1 (0.8)
Week 3-0.1 (0.9)-0.0 (1.2)
Week 4-0.2 (0.9)0.1 (1.5)
Week 6-0.1 (1.2)0.2 (1.5)
Week 8-0.0 (1.4)0.1 (1.3)

12. Secondary: 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)

Measure Type
Secondary
Measure Title
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9288
12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)
Units: units on a scale - Mean (Standard Deviation)
PCS: Baseline49.2 (8.7)50.2 (8.3)
PCS: Week 1253.0 (8.6)51.4 (7.5)

13. Secondary: 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)

Measure Type
Secondary
Measure Title
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Outcome Measures

LY686017Placebo
Participants Analyzed
Units: Participants
9288
12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)
Units: units on a scale - Mean (Standard Deviation)
MCS: Baseline45.7 (11.6)44.2 (11.2)
MCS: Week 1248.5 (10.0)49.7 (9.6)

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Serious Adverse Events

LY686017Placebo
Total, serious adverse events
No. of participants affected / at risk0/92 (0.00%)0/91 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold4% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
LY686017
50 milligrams (mg) daily by oral route for 12 weeks.
Placebo
Daily by oral route for 12 weeks.

Other Adverse Events

LY686017Placebo
Total, other adverse events
No. of participants affected / at risk73/92 (0.00%)68/91 (0.00%)
Diarrhoea
No. of participants affected / at risk5/92 (0.00%)3/91 (0.00%)
Dry mouth
No. of participants affected / at risk9/92 (0.00%)6/91 (0.00%)
Nausea
No. of participants affected / at risk7/92 (0.00%)14/91 (0.00%)
Fatigue
No. of participants affected / at risk8/92 (0.00%)7/91 (0.00%)
Irritability
No. of participants affected / at risk0/92 (0.00%)4/91 (0.00%)
Nasopharyngitis
No. of participants affected / at risk2/92 (0.00%)4/91 (0.00%)
Upper respiratory tract infection
No. of participants affected / at risk10/92 (0.00%)14/91 (0.00%)
Blood creatine phosphokinase increased
No. of participants affected / at risk4/92 (0.00%)2/91 (0.00%)
Increased appetite
No. of participants affected / at risk4/92 (0.00%)2/91 (0.00%)
Back pain
No. of participants affected / at risk5/92 (0.00%)4/91 (0.00%)
Dizziness
No. of participants affected / at risk7/92 (0.00%)3/91 (0.00%)
Headache
No. of participants affected / at risk6/92 (0.00%)9/91 (0.00%)
Somnolence
No. of participants affected / at risk7/92 (0.00%)0/91 (0.00%)
Insomnia
No. of participants affected / at risk5/92 (0.00%)3/91 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Chief Medical Officer
Eli Lilly and Company
800-545-5979