Does glucagon-like peptide-1 (GLP-1) receptor agonist stimulation reduce alcohol intake in patients with alcohol dependence: study protocol of a randomised, double-blinded, placebo-controlled clinical trial.
Does glucagon-like peptide-1 (GLP-1) receptor agonist stimulation reduce alcohol intake in patients with alcohol dependence: study protocol of a randomised, double-blinded, placebo-controlled clinical trial.
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DOI：
10.1136/bmjopen-2017-019562
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发表时间：
2018-07-16
期刊：
影响因子：
2.9
通讯作者：
Fink-Jensen A
中科院分区：
文献类型：
--
作者：
Antonsen KK;Klausen MK;Brunchmann AS;le Dous N;Jensen ME;Miskowiak KW;Fisher PM;Thomsen GK;Rindom H;Fahmy TP;Vollstaedt-Klein S;Benveniste H;Volkow ND;Becker U;Ekstrøm C;Knudsen GM;Vilsbøll T;Fink-Jensen A
酒精依赖是一个重大的公共卫生问题。它被诊断和治疗不足。即使接受治疗，超过2/3的禁欲治疗患者在第一年内会复发。因此，迫切需要对酒精依赖进行有效的医学治疗。在临床前实验中，胰高血糖素样肽-1（GLP-1）受体刺激已被证明可减少饮酒量。然而，据我们所知，尚未研究GLP-1受体激动剂在人体中的作用。设计、受试者和干预：将在一项双盲、安慰剂对照、随机临床试验中研究每周一次GLP-1受体激动剂艾塞那肽的作用。将招募114名门诊患者，并随机接受安慰剂或艾塞那肽治疗，每周一次，持续26周，作为认知行为治疗的补充。主要终点是减少“大量饮酒日”的数量。次要终点包括总饮酒量的变化、不饮酒天数、脑活动和功能的变化、吸烟状况、认知、生活质量指标以及磷脂酰乙醇作为饮酒生物标志物从基线至第26周随访的变化。状态：目前正在招募患者。已获得伦理批准。筛选前，将向所有患者提供有关试验的口头和书面信息。研究结果将通过同行评审出版物和会议报告传播，并有可能揭示酒精依赖的全新医学治疗方法。
Alcohol dependence is a major public health problem. It is underdiagnosed and undertreated. Even when treated, more than 2/3 of patients in abstinence-oriented treatment will relapse within the first year. Thus, there is an urgent need for efficacious medical treatment of alcohol dependence. Glucagon-like peptide-1 (GLP-1) receptor stimulation has proven to reduce alcohol consumption in preclinical experiments. However, the effect of GLP-1 receptor agonists in humans has to our knowledge, not yet been investigated. Design, participants and intervention: The effect of the once-weekly GLP-1-receptor-agonist exenatide will be investigated in a double-blinded, placebo-controlled, randomised clinical trial. 114 outpatients will be recruited and randomised to treatment with either placebo or exenatide once weekly for 26 weeks as a supplement to cognitive–behavioural therapy. The primary endpoint is reduction in number of ‘heavy drinking days’. The secondary endpoints include changes in total alcohol consumption, days without consumption, changes in brain activity and function, smoking status, cognition, measures of quality of life and changes in phosphatidylethanol as a biomarker of alcohol consumption from baseline to follow-up at week 26. Status: Currently recruiting patients. Ethical approval has been obtained. Before screening, all patients will be provided oral and written information about the trial. The study results will be disseminated by peer-review publications and conference presentations and has the potential to reveal a completely new medical treatment of alcohol dependence.
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影响因子：
3.4
作者：
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