Exenatide as an adjunct to nicotine patch for smoking cessation and prevention of postcessation weight gain among treatment-seeking smokers with pre-diabetes and/or overweight: study protocol for a randomised, placebo-controlled clinical trial.
Exenatide as an adjunct to nicotine patch for smoking cessation and prevention of postcessation weight gain among treatment-seeking smokers with pre-diabetes and/or overweight: study protocol for a randomised, placebo-controlled clinical trial.
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DOI：
10.1136/bmjopen-2023-072707
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发表时间：
2023-06-14
期刊：
影响因子：
2.9
通讯作者：
Schmitz, Joy M.
中科院分区：
文献类型：
--
作者：
Yammine, Luba;Verrico, Christopher D.;Versace, Francesco;Webber, Heather E.;Suchting, Robert;Weaver, Michael F.;Kosten, Thomas R.;Alibhai, Husein;Cinciripini, Paul M.;Lane, Scott D.;Schmitz, Joy M.
在美国，肥胖和吸烟是可预防死亡的两大主要原因。不幸的是，大多数吸烟者在戒烟后体重增加。戒烟后体重增加(PCWG)经常被认为是戒烟尝试的主要障碍之一，也是复发的常见原因。此外，过量的PCWG可能会导致代谢疾病的发生或进展，如高血糖和肥胖。目前戒烟疗法的疗效不大，这些疗法对减轻PCWG没有临床意义。在这里，我们概述了一种使用胰升糖素样肽1受体激动剂(GLP-1RA)的新方法，该方法已证明在减少食物和尼古丁摄入量方面有效。这份报告描述了一项双盲、安慰剂对照、随机临床试验的设计，该试验评估了GLP-1RA exenatide作为尼古丁贴片的辅助药物在戒烟和PCWG方面的效果。这项研究将在德克萨斯州休斯敦的两个大学附属研究地点进行，分别是德克萨斯大学健康中心成瘾神经行为研究中心和贝勒医学院迈克尔·E·德贝基退伍军人医学中心。样本将包括216名寻求治疗的吸烟者，他们患有糖尿病前期(血红蛋白A1c为5.7%-6.4%)和/或超重(体重指数为25公斤/平方米或以上)。参与者将被随机(1：1)接受皮下注射安慰剂或2 mg埃塞那肽，每周一次，为期14周。所有参与者都将接受经皮尼古丁替代疗法和短暂的戒烟咨询，为期14周。主要结果是持续4周的禁欲和治疗结束时体重的变化。次要结果是(1)戒酒和治疗结束后12周体重的变化，以及(2)脑电图仪测量的对香烟和食物相关线索的神经情感反应的变化。这项研究已经得到了德克萨斯大学保护人体健康委员会(HSC-MS-21-0639)和贝勒医学院机构审查委员会(H-50543)的批准。所有参与者都将签署知情同意书。研究结果将通过同行评议的出版物和会议发言予以传播。NCT05610800。
Obesity and smoking are the two leading causes of preventable death in the USA. Unfortunately, most smokers gain weight after quitting. Postcessation weight gain (PCWG) is frequently cited as one of the primary barriers to a quit attempt and a common cause of relapse. Further, excessive PCWG may contribute to the onset or progression of metabolic conditions, such as hyperglycaemia and obesity. The efficacy of the current treatments for smoking cessation is modest, and these treatments have no clinically meaningful impact on mitigating PCWG. Here, we outline a novel approach using glucagon-like peptide 1 receptor agonists (GLP-1RA), which have demonstrated efficacy in reducing both food and nicotine intake. This report describes the design of a double-blind, placebo-controlled, randomised clinical trial that evaluates the effects of the GLP-1RA exenatide as an adjunct to nicotine patches on smoking abstinence and PCWG. The study will be conducted at two university-affiliated research sites in Houston, Texas, the UTHealth Center for Neurobehavioral Research on Addiction and Baylor College of Medicine Michael E. DeBakey VA Medical Centre. The sample will consist of 216 treatment-seeking smokers with pre-diabetes (haemoglobin A1c of 5.7%–6.4%) and/or overweight (body mass index of 25 kg/m2 or above). Participants will be randomised (1:1) to receive subcutaneous injections of placebo or 2 mg exenatide, once weekly for 14 weeks. All participants will receive transdermal nicotine replacement therapy and brief smoking cessation counselling for 14 weeks. The primary outcomes are 4-week continuous abstinence and changes in body weight at the end of treatment. The secondary outcomes are (1) abstinence and changes in body weight at 12 weeks post end of treatment and (2) changes in neuroaffective responses to cigarette-related and food-related cues as measured by electroencephalogram. The study has been approved by the UTHealth Committee for the Protection of Human Subjects (HSC-MS-21-0639) and Baylor College of Medicine Institutional Review Board (H-50543). All participants will sign informed consent. The study results will be disseminated via peer-reviewed publications and conference presentations. NCT05610800.
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影响因子：
4.4
作者：
Borrelli, B;Mermelstein, R
通讯作者：
Mermelstein, R
使用晚期积极潜力估算事件相关潜在研究的统计能力。
影响因子：
3.7
作者：
Gibney KD;Kypriotakis G;Cinciripini PM;Robinson JD;Minnix JA;Versace F
通讯作者：
Versace F
影响因子：
3.1
作者：
Reimann F
通讯作者：
Reimann F
影响因子：
25.8
作者：
Cinciripini, Paul M.;Robinson, Jason D.;Karam-Hage, Maher;Minnix, Jennifer A.;Lam, Cho;Versace, Francesco;Brown, Victoria L.;Engelmann, Jeffrey M.;Wetter, David W.
通讯作者：
Wetter, David W.
影响因子：
5.9
作者：
Cinciripini, Paul M.;Blalock, Janice A.;Karam-Hage, Maher
通讯作者：
Karam-Hage, Maher