NCT00764660终止2 期
A Prospective, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Subjects With Alcohol Dependence.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 141
- 主要终点
- Percentage of Heavy Drinking Days
研究概览
简要总结
The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent after the scope and nature of the investigation, have been explained to the participant before screening;
- •Diagnosis of alcohol dependence - meeting at least 5 out of 7 criteria according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) specifier; one of which should be criterion 1 (tolerance) or 2 (withdrawal);
- •Primary complaints according to Mini-International Neuropsychiatric Interview (MINI) should be alcohol problems;
- •Participants must have gone through a detoxification program, have a clearly stated desire to stay abstinent and present at baseline with the following: be alcohol abstinent for at least 3 days, benzodiazepine free for at least 3 days, and a Clinical Institute Withdrawal Assessment (CIWA) score <10;
- •Age 18-65 years at screening;
- •Males, or females who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or who are non-pregnant, non-lactating and using a medically accepted method of contraception; these include condoms with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and hormonal contraceptives;
- •Body Mass Index (BMI) >16 kg/m^2;
- •Breath alcohol concentration < 0.02% (at screening and baseline)
排除标准
- •Participants requiring pharmacological treatment for a primary diagnosis of major depressive disorder, anxiety, panic disorder or social phobia;
- •Participants with psychotic disorders (according to MINI);
- •Participants with a medium or high suicidality risk (as assessed by MINI)
- •Active substance abuse (resulting in either physical or mental damage as defined by International Statistical Classification of Diseases and Related Health Problems, 10th revision [ICD10] or dependence other than alcohol (excluding nicotine) within 12 months prior to screening, e.g. cannabis, benzodiazepine, amphetamines, chlo(r)methiazole, opiates, cocaine, hallucinogens or other substances;
- •Use of one of the following drugs during the last 14 days prior to screening: cannabis, amphetamines, opiates, cocaine, hallucinogens;
- •Use of any medication that can have an effect on alcohol consumption within 30 days of study initiation, including naltrexone, acamprosate, disulfiram, ondansetron, topiramate, selective serotonin reuptake inhibitors (SSRIs), mirtazapine, varencicline, gabapentin, levetiracetam;
- •A clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma or retinal disease;
- •Untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, hematological, immunological or cerebrovascular disease, malignancy, or other chronic and/or degenerative process at screening;
- •Any clinically meaningful abnormal laboratory, vital sign, physical examination or electrocardiogram (ECG) finding which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations;
- •QTc interval (Fridericia corrected) at screening >450 ms (male), >470 ms (female);
- •Serious neuropsychiatric condition that can impair judgment or cognitive function (including dementia or amnestic disorder) to an extent that providing informed consent or complying with treatment is precluded;
- •History or present evidence of epileptic disorders or withdrawal seizures;
- •History of substance withdrawal delirium;
- •Breast-feeding woman, or a positive result of urine pregnancy test (at screening), or plan to become pregnant during the course of the trial (females only);
- •Pending legal charges with the potential for incarceration, probation, or parole;
- •Homelessness (less than 2 months stable residence);
- •Participation in a clinical trial during the 3 months prior to screening.
研究组 & 干预措施
SCH 900435
Experimental
Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
干预措施: SCH 900435 (Drug)
Placebo
Placebo Comparator
Participants received matching placebo tablets by mouth twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Heavy Drinking Days
时间窗: 12 weeks
Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval.
次要结局
- Number of Drinks Per Drinking Day(12 weeks)
- Number of Relapses Into Heavy Drinking(12 weeks)
- Number of Lapses Into Any Drinking(12 weeks)
- Time to First Relapse Into Drinking(12 weeks)
- Percentage of Abstinent Days(12 weeks)
- Percentage of Participants With Complete Abstinence(12 weeks)
- Global Functioning: Clinical Global Impression (CGI) - Severity of Illness(Day 84)
- Global Functioning: CGI - Therapeutic Effect(Day 84)
- Change From Baseline in Craving Visual Analog Scale (VAS) Score(Baseline and Day 84)
- Change From Baseline in Motivation VAS Score(Baseline and Day 84)
- Change From Baseline in Mood VAS Score(Baseline and Day 84)
- Number of Participants Who Experienced an Adverse Event (AE)(Up to 16 weeks)
- Number of Participants Who Discontinued Study Drug Due to an AE(Up to 12 weeks)
研究者
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