A Study in the Treatment of Alcohol Dependence.

A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence

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.

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.