Status:
COMPLETED
A Study in the Treatment of Alcohol Dependence.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alcohol Dependence
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
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 appro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00805441
Start Date
December 1 2008
End Date
July 1 2009
Last Update
September 17 2019
Active Locations (21)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Oceanside, California, United States, 92056
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States, 92103
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Deerfield Beach, Florida, United States, 33441
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North Miami, Florida, United States, 33161