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.
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。
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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