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A Study for the Treatment of Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LY2196044

placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 lower limit of normal (LLN) or above upper limit of normal (ULN)] unless corrected prior to randomization.
Have electrocardiogram (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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY2196044

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Heavy Drinking Days at Week 16 Endpoint

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Secondary Outcome Measures

Change From Baseline in Drinks Per Day at Week 16 Endpoint

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint

Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender*history, treatment*visit, baseline*visit, gender*treatment, gender*treatment*visit. Subject was treated as a random effect. An unstructured covariance structure was used.

Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint

DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. Subject was treated as a random effect. An unstructured covariance structure was used.

Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint

GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint

Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint

AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint

The BDI-II contains 21 items that characterize how the subject was feeling in the past 2 weeks. There is a 4-point scale for each item ranging from 0 to 3 (0=no depression; 3=very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint

BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Participant was asked to rate how much he or she has been bothered by each symptom over the past week. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). Total scores range from 0 to 63. The higher the score, the more severe the anxiety symptoms. LS Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint

The BIS-11 is a 30-item, self-administered impulsivity scale. Motor, cognitive, and non-planning domains are assessed and a total score is computed. This scale has previously been used in substance-abusing populations. Total scores range from 30-120. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.

Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint

Thoughts About Abstinence Scale was to measure participant's commitment to abstinence. It includes 3 items on a scale of 1-10: own desire to stop drinking (1=no desire to quit); own expectation of success in quitting (1=lowest expectation of success); how difficult to quit and remain abstinent (1=lowest amount of difficulty); and their goal related to alcohol use (scale of 1-7: 1=having no goal, up to total abstinence at 6 [7 was none of 6 above]). Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.

Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint

Q-LES-Q-SF is a self-report instrument that assesses the degree of enjoyment and satisfaction in daily life activities. The domains include: social relationships, living or house situation, and physical health. Total scores range from 14-70. Higher scores indicate better quality of life. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint

EWPS is a self-rated work productivity scale that assesses such topics as work hours, work missed, and behaviors and feelings related to the workplace. The EWPS will be completed only by subjects who work outside the home. There are 25 items and total scores range from 0-100. Higher scores indicate poorer productivity. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Population Pharmacokinetic (PK) - Apparent Clearance

Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.

Population Pharmacokinetic (PK) - Apparent Volume of Distribution

Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.

Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Change From Baseline in Supine Pulse Rate at Week 16 Endpoint

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Percentage of Participants Discontinuation Due to Adverse Events (AEs)

Percentage of participants discontinued study due to one or more AEs.

Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)

Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.

Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint

Orthostatic BP is the BP measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint

Orthostatic pulse rate is the pulse rate measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint

The revised CIWA-Ar scale measured the severity of alcohol withdrawal by rating 10 signs and symptoms: nausea; tremor; autonomic hyperactivity; anxiety; agitation; tactile, visual, and auditory disturbances; headache; and disorientation. Total scores range from 0-67. Higher scores indicate greater severity of withdrawal.

Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint

The GSRS is a clinician-administered scale used to assess upper and lower gastrointestinal physical symptoms. 15 items covering domains of abdominal pain, reflux syndrome, indigestion syndrome, diarrhea syndrome, and constipation syndrome were assessed with a 1-week recall period. Total scores range from 0-45. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.

Full Information

NCT ID

NCT00804570

First Posted

December 5, 2008

Last Updated

September 10, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00804570

Brief Title

A Study for the Treatment of Alcohol Dependence

Official Title

A Phase 2 Study of LY2196044 Compared With Placebo in the Treatment of Alcohol Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

375 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2196044

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LY2196044

Intervention Description

250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

once daily, orally, 16 weeks

Primary Outcome Measure Information:

Title

Percentage of Heavy Drinking Days at Week 16 Endpoint

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Drinks Per Day at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint

Description

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint

Description

The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint

Description

Time Frame

Week 16

Title

Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint

Description

Time Frame

Week 16

Title

Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint

Description

Time Frame

Week 16

Title

Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Population Pharmacokinetic (PK) - Apparent Clearance

Description

Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.

Time Frame

Over 16 weeks

Title

Population Pharmacokinetic (PK) - Apparent Volume of Distribution

Description

Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.

Time Frame

Over 16 weeks

Title

Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint

Description

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Supine Pulse Rate at Week 16 Endpoint

Description

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Time Frame

Baseline, Week 16

Title

Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint

Description

Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.

Time Frame

Baseline, Week 16

Title

Percentage of Participants Discontinuation Due to Adverse Events (AEs)

Description

Percentage of participants discontinued study due to one or more AEs.

Time Frame

Baseline through Week 16

Title

Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)

Description

Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.

Time Frame

Baseline through Week 16

Title

Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

Title

Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint

Description

Time Frame

Baseline through Week 16

Title

Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint

Description

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have Alcohol Dependence. Subjects must manifest at least the following 3 requirements for their diagnosis of Alcohol Dependence: Be tolerant, as defined by either of the following: A need for markedly increased amounts of alcohol to achieve intoxication or desired effect. Markedly diminished effect with continued use of the same amount of alcohol. Consume alcohol, often in larger amounts or over a longer period than was intended. 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 lower limit of normal (LLN) or above upper limit of normal (ULN)] unless corrected prior to randomization. Have electrocardiogram (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

Facility Name

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68133

Country

United States

Facility Name

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45237

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study for the Treatment of Alcohol Dependence

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