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临床试验/ACTRN12607000039482
ACTRN12607000039482
招募中
不适用

ovel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity to improve drinking outcomes and reduce comorbid mood or anxiety symptoms.

niversity of Sydney0 个研究点目标入组 60 人2007年1月12日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Alcohol Dependence
发起方
niversity of Sydney
入组人数
60
状态
招募中
最后更新
6年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2007年1月12日
结束日期
待定
最后更新
6年前
研究类型
Interventional
性别
All

研究者

入排标准

入选标准

  • Inclusion criteria for step 1: (i) alcohol dependence according to DSM\-IV criteria (Diagnostic and Statistical Manual of Mental Disorders 4th edition), with alcohol as the subject’s drug of choice, (ii) adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination), (iii) willingness to give written consent, (iv) abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone), (v) resolution of any clinically evident alcohol withdrawal (score 0\-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).
  • Entry criteria to step 2: (i) Completion of 3 weeks on acamprosate and/or natlrexone, (ii) resolution of any clinically evident alcohol withdrawal (score 0\-1 on RPA hospital alcohol withdrawal scale), (iii) case formulation and diagnosis for anxiety or depression (see below).

排除标准

  • Exclusion criteria for step 1: (i) sensitivity to study medications or therapy with these drugs within 6 months, (ii) active major psychiatric disorder associated with significant suicide risk, (iii) pregnancy or lactation, (iv) advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy), (v) other serious medical illness that would interfere with adherence to the study protocol.
  • Exclusion criteria 2: (i) Non\-compliance on acamprosate and/or naltrexone, (ii) alcohol consumption at baseline levels, (iii) resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment as appropriate within the service and continue to be monitored.

结局指标

主要结局

未指定

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