NCT01071187Unknown2 期
Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study
Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010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
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
研究概览
简要总结
The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.
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
- Double (Participant, Investigator)
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
- •diagnosis of alcohol dependence according to DSM IV
- •inpatient or outpatient
- •last alcohol consumption within 7-21 days before randomisation
- •subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation
- •diagnosis of nicotine dependence according to DSM IV
- •sufficient knowledge of the german language
- •subject is able to follow verbal and written instructions
- •subject is enabled to consent
- •ability of subject to understand character and individual consequences of the clinical trial
- •signed and dated informed consent of the subject must bei available before start of any specific trial procedures
- •subject must have a clearly stated desire to stay abstinent
- •women who are postmenopausal for more than two years or women with childbearing potential who practicing two years can participate in the study
排除标准
- •alcohol withdrawal delirium during last alcohol detoxification
- •alcohol induced dementia
- •severe renal insufficiency
- •detoxification against subject's will
- •women who are pregnant or breastfeeding or planning to become pregnant during the trial
- •women with childbearing potential who not practicing a medically accepted contraception during the trial
- •subjects with a known psychiatric disorder requiring treatment including a major depressive disorder, a substance dependence or abuse (besides nicotine, alcohol and cannabis)a psychosis or a dissocial personality disorder according to DSM-IV
- •elevated suicide risk, defined as one positive question in the suicide section of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
- •subjects with acute depression, defined as a HAMD17 (german version) sum score > 9 or a BDI (german version) sum score > 12
- •clinically relevant acute or chronic progressive neurologic, gastrointestinel, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
- •severe infection, a alcohol-induced hepatitis or a uncontrolled arterial hypertension
- •use of any medication that can effect on alcohol consumption within 14 days of study initiation including antidepressants, antipsychotics, anticonvulsives, benzodiazepines (besides given in the contect of the detoxification program, anticraving drugs as naltrexone, acamprosate and disulfiram and nicotine substitutes
- •subjects with following lab parameters: AST upper fivehold normal limit, PTT < 50%, leucocytes <2/nl, haemoglobin < 9g/dl, thrombocytes < 80/nl, creatinine > 1,5mg/dl and creatinine clearance < 30ml/min
- •history of cancer in 5 last years
- •known allergy against ingredient of study drug
- •history of myocardial infarction or stroke
- •participation in a clinical trial during last 90 days prior to screening
- •clinically relevant visual disturbance or ear disease
研究组 & 干预措施
Varenicline
Experimental
Treatment with varenicline with 0,5mg daily on day 1-3, 1mg daily on day 4-7 and 2mg daily on day 8-84.
干预措施: Varenicline (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days
时间窗: 12 weeks
次要结局
- Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview.(12 weeks)
- Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI)(12 weeks)
- Proportion of abstinent patients during the study, percentage of all patients(12 weeks)
- Compliance of the subjects(12 weeks)
- alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS)(12 weeks)
- Number of cigarettes per day(12 weeks)
- Number of nicotine abstinent days, percentage of the treatment days(12 weeks)
- Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview(12 weeks)
- Time in days to first heavy drinking, assessed by the time-line-follow-back-interview.(12 weeks)
- Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview.(12 weeks)
- Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence(12 weeks)
- Occurrence of adverse events(12 weeks)
- Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12)(12 weeks)
- Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI)(12 weeks)
- Changes in gamma-glutamyl transpeptidase levels(12 weeks)
- Absolute change in the Clinical Global Impression of Change (CGI)(12 weeks)
研究者
研究点 (2)
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