Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Alcohol consumption
研究概览
简要总结
There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.
详细描述
In summary, the specific aims of this project are:
- To assess the effectiveness of a novel stepped care intervention for alcohol dependent patients with co-morbid anxiety and/or depression compared to usual treatment for alcohol dependence in promoting abstinence from alcohol and increased quality of life and in reducing symptoms of anxiety and depression.
- To describe important factors relating to the maintenance of alcohol-related psychiatric comorbidity.
Step 1: All subjects will complete 12 weeks of pharmacotherapy (n = 120) on naltexone (50 mg, 1 tablet daily), acamprosate (333 mg, 2 tablets 3 times daily, reduced to 4/day for women <65kg), or a combination of the two. After a 3 week stabilization period, subjects will undergo complete formal assessment for anxiety and depression. Those subjects with a diagnosis of anxiety or depressive disorder regardless of drinking outcome will be offered the next step of care and followed up at 12-16 weeks.
Step 2: Subjects to undergo the next step of care (n = 30 per group, 60 in total) will be randomized by referring to the consecutively assigned subject identification number to a matched numbered envelope containing a random assignment card. Randomization will be stratified according to concomitant SSRI use. The treatment groups will be:
- Intervention for comorbid anxiety or depression, and
- Usual counseling care.
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
- Single (Outcomes Assessor)
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
- 否
入选标准
- •for Step 1:
- •alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
- •age 18-65,
- •adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
- •willingness to give written consent,
- •abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
- •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).
排除标准
- •for Step 1:
- •sensitivity to study medications or therapy with these drugs within 6 months,
- •active major psychiatric disorder associated with significant suicide risk,
- •pregnancy or lactation,
- •advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
- •other serious medical illness that would interfere with adherence to the study protocol.
- •Entry criteria to step 2:
- •Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
- •case formulation and diagnosis for anxiety or depression (see below).
- •Exclusion criteria 2:
- •Non-compliance on acamprosate and/or naltrexone,
- •alcohol consumption at baseline levels,
- •resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment
结局指标
主要结局
Alcohol consumption
时间窗: 12 weeks
Time to relapse (\>5 drinks on any one day)
Time to lapse
时间窗: 12 weeks
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
amount of alcohol consumption
时间窗: 12 weeks
expressed as the average consumption per drinking day
次要结局
- Improvement in depressive or anxiety symptoms(12 weeks)
- Diagnosis severity(16 weeks)
研究者
Professor Paul Haber
Medical Director
South West Sydney Local Health District