Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Rate of relapse in alcohol drinking
研究概览
简要总结
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.
However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.
The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.
详细描述
- inclusion at Day 5 of the outpatient alcohol detoxification procedure
- randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"
- tapering of diazepam over the 10 days following the beginning of the detoxification procedure in the first arm; tapering of diazepam over the 30 days following the beginning of the detoxification procedure in the second arm.
- 3-month-long follow-up after detoxification. Objective of maintaining abstinence from alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support based on the BRENDA model.
- Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back method.
- Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and 90 (final assessment).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-Tr criteria for alcohol dependence
- •Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion
排除标准
- •contraindication for outpatient detoxification
- •occurrence of delirium tremens or seizures during the pre-inclusion period
- •contraindication for using diazepam
- •any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year (except from tobacco)
- •concurrent axis-I psychiatric disorder
- •concurrent neurological pathology or cognitive impairment
- •concurrent social risk, i.e., homelessness or social isolation
- •liver failure, cancer, or significant breathing disorder
研究组 & 干预措施
PD = "prolonged diazepam"
Diazepam will be slowly tapered to be stopped at day 30
干预措施: Diazepam (Drug)
AD = "as-usual diazepam"
Diazepam treatment duration will not exceed 10 days (commonly recommended duration for alcohol detoxification).
干预措施: Diazepam (Drug)
结局指标
主要结局
Rate of relapse in alcohol drinking
时间窗: at 3 months
Proportion of patients who will have reported any alcohol drinking over the three months following the beginning of the detoxification procedure (using the alcohol timeline follow-back method).
次要结局
- Occurrence of adverse events(Over the first month, at 3 months)
- Level of self-reported anxiety(at 1 month; at 3 months)
- Ratio of drinking days/heavy drinking days(over the first month, at 3 months)
- Level of alcohol craving(at 1 month; at 3 months)
- Average weekly alcohol consumption(at 1 month; at 3 months)
- Rate of relapse in heavy drinking(at 1 month; at 3 months)
- Level of clinician-assessed anxiety(at 1 month; at 3 months)