Initiating Acamprosate Within Versus Post-detoxification in the Rehabilitative Treatment of Alcohol Dependence.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6) % days heavy drinking.
研究概览
简要总结
Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with acamprosate.
详细描述
Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment phase (RP).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2
Placebo
干预措施: Placebo (Drug)
1
Acamprosate
干预措施: Acamprosate (Drug)
结局指标
主要结局
6) % days heavy drinking.
时间窗: Phase II: 10 weeks
5) % days abstinent;
时间窗: Phase II: 10 weeks
1) the mean number of adverse events rated moderate to severe;
时间窗: Phase II: 10 weeks
2) the week of detoxification treatment discontinuation;
时间窗: Phase I: up to 2 weeks
4) % pills taken over what was proposed to be prescribed (medication exposure);
时间窗: Phase II: 10 weeks
3) the total amount of oxazepam given;
时间窗: Phase I: up to 2 weeks
4) the rate of change in CIWA scores.
时间窗: Phase I: up to 2 weeks
2) the week of open-label treatment discontinuation;
时间窗: Phase II: 10 weeks
3) any reemergence of detoxification symptoms;
时间窗: Phase II: 10 weeks
次要结局
- Changes in alcohol craving will be measured by Penn Alcohol Craving Scale (PACS; Flannery et al, 1999)(12 weeks)
- Changes in social functioning will be measured by several of the subscales of the Addiction Severity Index (ASI; McLellan et al, 1992); namely, medical, legal, psychiatric, and family/social.(12 weeks)
- Changes in depressive symptoms will be measured by the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D; Hamilton 1967)(12 weeks)
- Quality of Life, measured by the Short Form-36 Health Status Questionnaire (SF-36; Ware & Sherbourne, 1999)(12 weeks)
- Changes in anxiety symptoms will be measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A; Hamilton, 1969)(12 weeks)
- Overall clinical impression of improvement will be measured by the Clinical Global Impression Scale (CGI)(12 weeks)