Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

Percentage of Heavy Drinking Days at Week 16 Endpoint
The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used.
Week 16

Secondary Outcomes (26)

Change From Baseline in Drinks Per Day at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint
Baseline, Week 16
Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint
Baseline, Week 16
+21 more secondary outcomes

Study Arms (2)

LY2196044

EXPERIMENTAL

Drug: LY2196044

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

LY2196044DRUG

250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks

LY2196044

placeboDRUG

once daily, orally, 16 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. Subjects must manifest at least the following 3 requirements for their diagnosis of Alcohol Dependence:
Be tolerant, as defined by either of the following:
A need for markedly increased amounts of alcohol to achieve intoxication or desired effect.
Markedly diminished effect with continued use of the same amount of alcohol.
Consume alcohol, often in larger amounts or over a longer period than was intended.
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.

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.