Conditions

Alcohol Dependence

Keywords

Alcoholic

Outcome Measures

Primary Outcomes (1)

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.
Baseline, Weeks 4 and 8 and 12 and 16

Secondary Outcomes (12)

Percent Days Abstinent Per Month
Baseline and Weeks 4 and 8 and 12 and 16.
Number of Drinks Per Drinking Day During a Month
Baseline and Weeks 4 and 8 and12 and 16
Time to First Heavy Drinking Day
Baseline up to Week 12
Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale
Baseline, Week 12
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
+7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

LY686017

EXPERIMENTAL

Drug: LY686017

Interventions

LY686017DRUG

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

LY686017

PlaceboDRUG

Daily by oral route for 12 weeks

Placebo

Eligibility Criteria

Age21 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+1 more criteria

Contact the study team to confirm eligibility.