A Study in the Treatment of Alcohol Dependence.



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 65
Updated:2/15/2018
Start Date:December 2008
End Date:July 2009

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A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence

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.


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.
We found this trial at
21
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