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A Study in the Treatment of Alcohol Dependence.

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: December 5, 2008
Last updated: May 27, 2010
Last verified: May 2010
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.

Condition Intervention Phase
Alcohol Dependence
Drug: LY686017
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percent reduction in heavy drinking days. [ Time Frame: Baseline, week 4, week 8, week 12 and week 16. ]

Secondary Outcome Measures:
  • Percent days abstinent per month. [ Time Frame: baseline, week 4, week 8, week 12 and week 16. ]
  • Number of drinks per drinking day during a month. [ Time Frame: baseline, week 4, week 8, week 12 and week 16. ]
  • Drinker inventory of Consequences (DrInC) [ Time Frame: baseline, week 12 ]
  • Alcohol Urge questionnaire - change from baseline. [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 10 and week 12. ]
  • Penn Alcohol Craving Scale - change from baseline. [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 10 and week 12. ]
  • Beck Depression Inventory II (BDI-II) - change from baseline. [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 10 and week 12. ]
  • Beck Anxiety Index - change from baseline. [ Time Frame: baseline, week 6 and week 12 ]
  • Gamma-glutamyl transferase -change from baseline. [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 10 and week 12. ]
  • Plasma carbohydrate deficient transferring (CDT) - change from baseline. [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 6, week 8, week 10 and week 12. ]
  • Health outcomes (Short Form 12) [ Time Frame: baseline and week 12 ]

Enrollment: 190
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Daily by oral route for 12 weeks
Experimental: LY686017 Drug: LY686017
50 mg daily by oral route for 12 weeks


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, OCD, 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00805441

  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00805441     History of Changes
Other Study ID Numbers: 12422
H8R-MC-HJAQ ( Other Identifier: Eli Lilly and Company )
Study First Received: December 5, 2008
Last Updated: May 27, 2010

Keywords provided by Eli Lilly and Company:

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on April 28, 2017