A Study in the Treatment of Alcohol Dependence.
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: LY686017; Placebo
Intervention description: 50 milligrams (mg) daily by oral route for 12 weeks; Daily by oral route for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcoholic

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.