NCT00004552已完成2 期
Etiology and Treatment of Alcohol Dependence
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
研究概览
简要总结
This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol abuse or dependence.
- •Able to read English at 6th grade level or higher and to complete study evaluations.
- •Average weekly alcohol consumption of standard drinks of at least 25 drinks for men and 20 drinks for women.
- •No more than 3 days abstinence/week.
排除标准
- •Current abuse or dependence on other substances, other than nicotine and marijuana.
- •Positive test results for opiates, cocaine, benzodiazepines and barbiturates.
- •Regular use of psychoactive drugs including anxiolytics and antidepressants.
- •Psychiatrically disabled.
- •Hepatocellular disease or a history of cirrhosis.
- •Medical conditions that would prevent the consumption of alcohol, increase the risk of complicated alcohol withdrawal, or prevent the use of acamprosate such as a history of neurological trauma or disease, seizures, delirium, or hallucinations, hepatic, cardiovascular, metabolic, endocrine, gastrointestinal, or kidney disease.
- •Individuals who have had any significant physical illnesses during the two weeks prior to receiving study medication or during the medication treatment period prior to the withdrawal study.
- •Medically detoxified from alcohol more than once within the past five years.
- •Alcohol withdrawal symptoms requiring management with benzodiazepines.
- •Females who are pregnant, nursing or not using a reliable method of birth control.
- •Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past six months.
- •Individuals who report disliking spirits and have taken investigational drug or naltrexone within 4 weeks immediately preceding admission to study.
- •Individuals who report any daily drug use during the thirty days prior to randomization for the following: anxiolytics, beta blockers, central nervous system stimulants, hypnotics, non-therapeutic doses of neuroleptics and antidepressants, drugs with psychotropic activity or drugs which cause excessive sedation.
- •Subjects who have donated blood within the past six weeks.
研究者
研究点 (2)
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