A Study in the Treatment of Alcohol Dependence.

Lilly

Status and phase

Completed

Phase 2

Conditions

Alcohol Dependence

Treatments

Drug: Placebo

Drug: LY686017

Study type

Interventional

Funder types

Industry

Identifiers

NCT00805441

H8R-MC-HJAQ (Other Identifier)

12422

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.