A Phase 2 Study of LY686017 Compared With Placebo for the Treatment of Alcohol Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Heavy Drinking Days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
LY686017
干预措施: LY686017 (Drug)
结局指标
主要结局
Percent Change From Baseline in Heavy Drinking Days
时间窗: Baseline, Weeks 4 and 8 and 12 and 16
The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer \[5% alcohol by volume (abv)\], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.
次要结局
- Change From Baseline Beck Anxiety Index (BAI) Total Score(Baseline, Weeks 6 and 12)
- Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)(Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12)
- Percent Days Abstinent Per Month(Baseline and Weeks 4 and 8 and 12 and 16.)
- Number of Drinks Per Drinking Day During a Month(Baseline and Weeks 4 and 8 and12 and 16)
- Time to First Heavy Drinking Day(Baseline up to Week 12)
- Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale(Baseline, Week 12)
- Change From Baseline in Alcohol Urge Questionnaire (AUQ)(Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12)
- Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score(Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12)
- Change From Baseline in Penn Alcohol Craving Scale (PACS)(Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12)
- Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)(Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12)
- 12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)(Baseline and Week 12)
- 12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)(Baseline and Week 12)