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临床试验/NCT00120601
NCT00120601Unknown4 期

The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

University of Sydney2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年3月最近更新:
适应症
相关药物

试验速览

阶段
4 期
入组人数
200
试验地点
2
主要终点
Time (days) to relapse

研究概览

简要总结

The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.

详细描述

The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.

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

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

入选标准

  • Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
  • Ages 18-65
  • Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
  • Willingness to give written informed consent
  • Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal

排除标准

  • Opiate abuse within the last one month
  • Sensitivity to study medications or therapy with these drugs within 6 months
  • Active major psychiatric disorder associated with psychosis or significant suicide risk
  • Pregnancy or lactation
  • Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)

结局指标

主要结局

Time (days) to relapse

Time (days) to lapse

Days abstinence

Drinks per drinking day

Biochemical measures of liver function

次要结局

  • Anxiety
  • Depression
  • Global physical health
  • Craving
  • Stress
  • Global mental health

研究者

申办方类型
Other

研究点 (2)

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