NCT00846859已完成2 期
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Sahlgrenska University Hospital, Sweden3 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women
研究概览
简要总结
The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30-70 years at screening
- •Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
- •≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days
- •Participants must have signed the informed consent
排除标准
- •Subject to treatment of alcohol withdrawal within 30 days of study initiation
- •Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation
- •Subject to treatment of depression within 3 months of study initiation
- •The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
- •Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
- •History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
- •Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values.
- •Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
- •Any ongoing serious psychiatric or somatic disorder
- •Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
- •The concurrent use of illicit drugs based on urine-toxicity test
- •The need for detoxification
- •Diabetes Mellitus Type 1
- •Suicidal risk
- •Homelessness
- •Additional factors that implies to the investigator/physician that the participant will not be completing the study
研究组 & 干预措施
varenicline
Experimental
干预措施: varenicline (Champix/Chantix) (Drug)
placebo
Placebo Comparator
干预措施: placebo for varenicline (Drug)
结局指标
主要结局
Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women
次要结局
- Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline.
- Percentage (and number) of abstaining days compared to baseline.
- Drinks per drinking day compared to baseline.
- Alcohol consumption as measured by alcohol markers in blood compared to baseline.
- Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline.
- Compliance as measured by diary and returned medication packages.
研究者
研究点 (3)
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