A Study in the Treatment of Alcohol Dependence.

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00805441
First received: December 5, 2008
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent days abstinent per month. [ Time Frame: baseline, week 4, week 8, week 12 and week 16. ] [ Designated as safety issue: Yes ]
  • Number of drinks per drinking day during a month. [ Time Frame: baseline, week 4, week 8, week 12 and week 16. ] [ Designated as safety issue: Yes ]
  • Drinker inventory of Consequences (DrInC) [ Time Frame: baseline, week 12 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Beck Anxiety Index - change from baseline. [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • Health outcomes (Short Form 12) [ Time Frame: baseline and week 12 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805441

  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00805441     History of Changes
Other Study ID Numbers: 12422, H8R-MC-HJAQ
Study First Received: December 5, 2008
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Alcoholic

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014