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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 人开始时间: 2007年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

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.

研究者

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