NCT00804570已完成2 期
A Phase 2 Study of LY2196044 Compared With Placebo in the Treatment of Alcohol Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Percentage of Heavy Drinking Days at Week 16 Endpoint
研究概览
简要总结
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.
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
- Triple (Participant, Care Provider, Investigator)
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. 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.
排除标准
- •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 LY
- •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.
研究组 & 干预措施
LY2196044
Experimental
干预措施: LY2196044 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Heavy Drinking Days at Week 16 Endpoint
时间窗: Week 16
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.
次要结局
- Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint(Week 16)
- Change From Baseline in Drinks Per Day at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint(Week 16)
- Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Supine Pulse Rate at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint(Baseline, Week 16)
- Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint(Week 16)
- Population Pharmacokinetic (PK) - Apparent Volume of Distribution(Over 16 weeks)
- Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Population Pharmacokinetic (PK) - Apparent Clearance(Over 16 weeks)
- Percentage of Participants Discontinuation Due to Adverse Events (AEs)(Baseline through Week 16)
- Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint(Baseline, Week 16)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)(Baseline through Week 16)
- Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint(Baseline, Week 16)
- Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint(Baseline, Week 16)
- Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint(Baseline through Week 16)
- Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint(Baseline, Week 16)
研究者
研究点 (1)
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