A Study for the Treatment of Alcohol Dependence.

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00804570
First received: December 5, 2008
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

The Primary objective of this study is to test whether LY2196044 can reduce the number of heavy drinking days per month in people with alcohol dependence. Each subject will undergo a screening and assessment period (including medication washout) prior to randomization into a 16 week double blind treatment period.


Condition Intervention Phase
Alcohol Dependence
Drug: LY2196044
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)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY2196044 Compared With Placebo in the Treatment of Alcohol Dependence.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean % reduction in heavy drinking days using the Timeline Followback Method. [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obsessive Compulsive Drinking Scale [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Drinker Inventory of Consequences [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Gamma-Glutamyltransferase and Carbohydrate-Deficient Transferrin [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • The Beck Depression Inventory II [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • The Beck Anxiety Inventory [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • The Barratt Impulsivity Scale-11 [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Thoughts About Abstinence Scale [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire Short Form [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Endicott Work Productivity Scale [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Population PK methodology [ Time Frame: Over 16 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory Values [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Discontinuation rates due to Adverse Events [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Treatment-emergent adverse events [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Orthostatic hypotension [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Institute Withdrawal Assessment for Alcohol [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]
  • Gastrointestinal Symptom Rating Scale [ Time Frame: Over 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 371
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2196044 Drug: LY2196044
250 mg (titrate via 1 week at 50 mg and 1 week at 125 mg), QD, PO, 16 weeks
Placebo Comparator: Placebo Drug: placebo
QD, PO, 16 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. Subjects must manifest at least the following 3 requirements for their diagnosis of Alcohol Dependence:

    1. Be tolerant, as defined by either of the following:

      1. A need for markedly increased amounts of alcohol to achieve intoxication or desired effect.
      2. Markedly diminished effect with continued use of the same amount of alcohol.
    2. Consume alcohol, often in larger amounts or over a longer period than was intended.
    3. Have a persistent desire or unsuccessful effort(s) to reduce or control alcohol use.
  • Drink on average more than 14 drinks (women) or 21 drinks (men) per week with at least 2 heavy drinking days per week (≥4 drinks/day for women and ≥5 drinks/day for men) during the consecutive 30 day period prior to Screening and maintained through Randomization.
  • Endorse abstinence or reduction in drinking.
  • Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use a reliable method of birth control during the study and for 2 months following the last dose of study drug.

Exclusion Criteria:

  • Have experienced an acute alcohol withdrawal syndrome within the past 6 months or are currently at significant risk of suffering an acute alcohol withdrawal syndrome.
  • Have a history of serious head injury, intracranial neoplasm or hemorrhage, prior seizure (other than remote history of childhood febrile seizure), or other condition that would place the subject at increased risk of seizure.
  • Have ever taken anticonvulsants for seizure control.
  • Are diagnosed with substance dependence or abuse (other than alcohol, cannabis, nicotine, or caffeine) within 6 months prior to Screening.
  • Are receiving intensive behavioral or psychological therapy, delivered by a licensed or certified alcohol treatment specialist, for alcohol dependence.
  • Meet criteria for a lifetime diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, or other psychoses.
  • Have signs and symptoms of an active illness within the past 6 months of Screening for a diagnosis of Major Depressive Disorder (MDD) or Anxiety Disorder, or have a Cognitive Disorder diagnosed by clinical assessment. Subjects who were diagnosed with MDD in the more distant past, but have had a recent diagnosis of an active Major Depressive Episode, will not be eligible.
  • Are actively suicidal, in the opinion of the investigator.
  • Have taken any opiate or opioid analgesic (for example, codeine, hydrocodone) or an opiate receptor antagonist (for example, naltrexone) within 14 days prior to Screening.
  • Are currently taking any medication excluded by the protocol.

    • Note: Subjects who discontinue/washout excluded medications prior to Randomization are not excluded from participation.
  • Have evidence of significant active cardiac, respiratory, renal, gastrointestinal, or hematologic disease.
  • Have acute or active hepatitis or hepatic inflammation.
  • Have a history of cirrhosis or laboratory evidence of significant hepatocellular injury.
  • Have plasma levels of sodium, potassium, calcium, magnesium, or phosphorous that fall outside of established reference ranges of the central laboratory for those analytes (that is, below LLN or above ULN) unless corrected prior to randomization.
  • Have ECG abnormalities obtained at Screening that are clinically significant with regard to the subject's participation in the study.
  • Are women who are either pregnant or breast feeding.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Have previously completed or withdrawn from this study or any other study investigating LY2196044.
  • Are unable, unreliable, and/or unwilling to provide informed consent, 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: NCT00804570

Locations
United States, Indiana
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.
Indianapolis, Indiana, United States, 46260
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.
Lafayette, Indiana, United States, 47905
United States, Maryland
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.
Baltimore, Maryland, United States, 21205
United States, Massachusetts
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.
Belmont, Massachusetts, United States, 02478
United States, Minnesota
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.
Rochester, Minnesota, United States, 55905
United States, Nebraska
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.
Omaha, Nebraska, United States, 68133
United States, New Hampshire
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.
Lebanon, New Hampshire, United States, 03756
United States, New York
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.
New York, New York, United States, 10016
United States, North Carolina
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.
Chapel Hill, North Carolina, United States, 27599
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.
Charlotte, North Carolina, United States, 28211
United States, Ohio
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.
Cincinnati, Ohio, United States, 45237
United States, Oregon
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.
Portland, Oregon, United States, 97210
United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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.
Providence, Rhode Island, United States, 02908
United States, South Carolina
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.
Charleston, South Carolina, United States, 29425
United States, Texas
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 Antonio, Texas, United States, 78229
United States, Washington
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.
Seattle, Washington, United States, 98104
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: NCT00804570     History of Changes
Other Study ID Numbers: 11359, H9T-MC-NABJ
Study First Received: December 5, 2008
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014