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

Use our guide to learn which trials are right for you!

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
sites
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1213
mi
from 91732
Austin, TX
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2044
mi
from 91732
Canton, OH
Click here to add this to my saved trials
2208
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
2312
mi
from 91732
Deerfield Beach, FL
Click here to add this to my saved trials
1223
mi
from 91732
Desoto, TX
Click here to add this to my saved trials
2367
mi
from 91732
Havertown, PA
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
967
mi
from 91732
Kirkland, WA
Click here to add this to my saved trials
1757
mi
from 91732
Lafayette, IN
Click here to add this to my saved trials
1702
mi
from 91732
Naperville, IL
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
2319
mi
from 91732
North Miami, FL
Click here to add this to my saved trials
73
mi
from 91732
Oceanside, CA
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
1401
mi
from 91732
Shreveport, LA
Click here to add this to my saved trials