Phase 2
Completed N=190
A Study in the Treatment of Alcohol Dependence.
Source: ClinicalTrials.gov NCT00805441 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Percent Change From Baseline in Heavy Drinking Days — -45.63; -39.72; -60.98; -49.88 percent of heavy drinking days
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Heavy Drinking Days |
-45.63; -39.72; -60.98; -49.88; -68.56; -57.44 | — |
| SECONDARY Percent Days Abstinent Per Month |
11.63; 14.54; 30.28; 29.44; 40.73; 40.07 | — |
| SECONDARY Number of Drinks Per Drinking Day During a Month |
7.04; 7.35; 3.92; 4.69; 3.03; 3.36 | — |
| SECONDARY Time to First Heavy Drinking Day |
7.3; 8.0 | — |
| SECONDARY Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale |
-2.9; -3.9; -3.1; -2.3; -2.0; -2.1 | — |
| SECONDARY Change From Baseline in Alcohol Urge Questionnaire (AUQ) |
-2.9; -2.9; -5.0; -3.6; -5.3; -6.0 | — |
| SECONDARY Change From Baseline in Penn Alcohol Craving Scale (PACS) |
-1.0; -0.6; -1.3; -1.0; -1.4; -1.0 | — |
| SECONDARY Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score |
0.0; -1.4; -0.9; -1.0; -1.5; -1.2 | — |
| SECONDARY Change From Baseline Beck Anxiety Index (BAI) Total Score |
-1.9; -2.3; -1.3; -2.0 | — |
| SECONDARY Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT) |
-5.4; -1.3; -6.6; -2.1; -9.7; -3.7 | — |
| SECONDARY Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT) |
-0.1; -0.0; -0.2; -0.1; -0.1; -0.0 | — |
| SECONDARY 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS) |
49.2; 50.2; 53.0; 51.4 | — |
| SECONDARY 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS) |
45.7; 44.2; 48.5; 49.7 | — |
Eligibility 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, 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.
Data sourced from ClinicalTrials.gov (NCT00805441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.