a study in the treatment of alcohol dependence.

Conditions: Alcohol Dependence

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.


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.

Keywords: alcoholic