A Study for the Treatment of Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: LY2196044; placebo
Intervention description: 250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks; once daily, orally, 16 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The Primary objective of this study is to test whether LY2196044 can reduce the number of
      heavy drinking days per month in people with alcohol dependence. Each subject will undergo a
      screening and assessment period (including medication washout) prior to randomization into a
      16 week double blind treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Alcohol Dependence. Subjects must manifest at least the following 3 requirements
             for their diagnosis of Alcohol Dependence:

               1. Be tolerant, as defined by either of the following:

                    1. A need for markedly increased amounts of alcohol to achieve intoxication or
                       desired effect.

                    2. Markedly diminished effect with continued use of the same amount of alcohol.

               2. Consume alcohol, often in larger amounts or over a longer period than was
                  intended.

               3. Have a persistent desire or unsuccessful effort(s) to reduce or control alcohol
                  use.

          -  Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least
             2 heavy drinking days per week (≥4 drinks/day for women and ≥5 drinks/day for men)
             during the consecutive 30 day period prior to Screening and maintained through
             Randomization.

          -  Endorse abstinence or reduction in drinking.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test
             and agree to use a reliable method of birth control during the study and for 2 months
             following the last dose of study drug.

        Exclusion Criteria:

          -  Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are
             currently at significant risk of suffering an acute alcohol withdrawal syndrome.

          -  Have a history of serious head injury, intracranial neoplasm or hemorrhage, prior
             seizure (other than remote history of childhood febrile seizure), or other condition
             that would place the subject at increased risk of seizure.

          -  Have ever taken anticonvulsants for seizure control.

          -  Are diagnosed with substance dependence or abuse (other than alcohol, cannabis,
             nicotine, or caffeine) within 6 months prior to Screening.

          -  Are receiving intensive behavioral or psychological therapy, delivered by a licensed
             or certified alcohol treatment specialist, for alcohol dependence.

          -  Meet criteria for a lifetime diagnosis of Schizophrenia, Schizoaffective Disorder,
             Bipolar I Disorder, or other psychoses.

          -  Have signs and symptoms of an active illness within the past 6 months of Screening for
             a diagnosis of Major Depressive Disorder (MDD) or Anxiety Disorder, or have a
             Cognitive Disorder diagnosed by clinical assessment. Subjects who were diagnosed with
             MDD in the more distant past, but have had a recent diagnosis of an active Major
             Depressive Episode, will not be eligible.

          -  Are actively suicidal, in the opinion of the investigator.

          -  Have taken any opiate or opioid analgesic (for example, codeine, hydrocodone) or an
             opiate receptor antagonist (for example, naltrexone) within 14 days prior to
             Screening.

          -  Are currently taking any medication excluded by the protocol.

               -  Note: Subjects who discontinue/washout excluded medications prior to
                  Randomization are not excluded from participation.

          -  Have evidence of significant active cardiac, respiratory, renal, gastrointestinal, or
             hematologic disease.

          -  Have acute or active hepatitis or hepatic inflammation.

          -  Have a history of cirrhosis or laboratory evidence of significant hepatocellular
             injury.

          -  Have plasma levels of sodium, potassium, calcium, magnesium, or phosphorous that fall
             outside of established reference ranges of the central laboratory for those analytes
             [that is, below lower limit of normal (LLN) or above upper limit of normal (ULN)]
             unless corrected prior to randomization.

          -  Have electrocardiogram (ECG) abnormalities obtained at Screening that are clinically
             significant with regard to the subject's participation in the study.

          -  Are women who are either pregnant or breast feeding.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY2196044.

          -  Are unable, unreliable, and/or unwilling to provide informed consent, make themselves
             available for the duration of the study or abide by study procedures and restrictions.