Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of days abstinent
研究概览
简要总结
The goal of this clinical trial is to determine the efficacy of baclofen for the treatment of alcohol use disorder (AUD) in patients with or without comorbid anxiety symptoms. The main questions it aims to answer are:
- Do we see more abstinent days after the study period in patients with high anxiety symptoms compared to low anxiety symptoms?
- Do we observe additional differences between patients with high- and low anxiety symptoms in: any drinking at the end of treatment (yes/no), number of patients who respond to treatment, anxiety score reduction, autonomic responses, craving scores, drinking motives and side effects?
Participants already taking baclofen as part of routine clinical care for treatment of AUD will be asked to answer several questionnaires over a 6 week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Meeting DSM-5 criteria for AUD
- •Able to understand and provide written consent
- •Already receiving baclofen or started with baclofen at start of hospitalization
- •Therapeutic desire towards alcohol abstinence
排除标准
- •Concurrent substance use disorder other than nicotine or cannabis
- •Clinically significant psychiatric illness that requires pharmacotherapy, unless stable and no changes in medication has been made in the last 30 days
- •Clinically significant medical diseases that may pose a risk to continuing baclofen use
- •Pregnant or currently breastfeeding women
研究组 & 干预措施
Baclofen
SIngle arm study, investigating baclofen as standard care uptitrated to maximal tolerated dosage upon clinical judgment and not part of the trial. The active intervention involves questionnaires.
干预措施: Questionnaires (Other)
结局指标
主要结局
Number of days abstinent
时间窗: Weekly during 6 week study period
Number of days abstinent during baclofen treatment between AUD patients with and without comorbid anxiety, as measured by the TLFB.
次要结局
- Drinking motives(At start of 6 week study period)
- Any drinking(After 6 week study period)
- Treatment response(After 6 week study period)
- Autonomic symptom responses(At start and after 6 week study period)
- Craving scores(Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period)
- Anxiety score reduction(At start and after 6 week study period)
- Side effects(Weekly during 6 week study period)