Randomized controlled trial of varenicline for cessation of nicotine vaping in adolescent non-smokers

项目总结/摘要 青少年尼古丁vaping的流行率比任何已知的药物都上升得更快。部分地区 在美国，超过三分之一的高中生经常吸食尼古丁。这种迅速上升的受欢迎程度 电子尼古丁输送装置（ENDS，"电子香烟"，vapes）已经扭转了50年的非正常化 青少年吸烟，使青少年处于尼古丁依赖的高风险，吸烟，其他药物使用， 和直接对健康的负面影响。虽然合理的监管提高了购买年龄， 消除甜味和薄荷味应该抑制青少年尼古丁vaping的新吸收， 吸烟者，这些政策导致许多人寻求戒烟治疗。据估计， 在美国，有100万青少年对尼古丁上瘾。没有治疗试验的vaping停止 据我们所知，迄今已出版。有效的干预措施对于帮助估计100万美国人至关重要。 现在对尼古丁上瘾的青少年应该戒烟，不要开始吸烟。伐尼克兰，最 有效的已知戒烟药物，已被良好耐受，并与显着较高的 在最近两个小型随机研究中， 青少年吸烟者的对照试验。在我们小组最近的一个系列中，varenicline与文本vaping一起 戒烟支持与65%（52例患者中的34例）的长期电子烟戒烟率（3 - 9 在依赖vaped尼古丁的非吸烟青少年中， 到目前为止，在这一人群中，替代疗法与约21%的戒烟率相关。 在目前的研究中，我们建议测试已知的尼古丁最有效的治疗方法伐尼克兰 成瘾，帮助尼古丁依赖的青少年戒烟尼古丁。为此，我们将招收300名 16 - 20岁的青少年，谁vape，尼古丁依赖，不吸烟，并希望戒烟。青少年将 通过高中，大学和大波士顿的社区招募，那些符合条件的人将被 入组一项伐尼克兰高达1 mg bid的双盲、安慰剂对照、平行组、意向治疗试验 在12周的主动行为控制干预中加入12周的短信， 专门为青少年戒烟而设计的团体行为支持。药物依从性和试验 保留，之前青少年戒烟试验的挑战，将得到激励和支持， 创新的AiCure智能手机应用程序，用于远程直接观察每日vaping的剂量和收集 和其他数据。该提案是对紧急和日益增长的要求vaping停止治疗的回应， 来自患者、其家人和学校的青少年。积极的结果将定义一种有效的治疗方法， 可以用于这种快速移动的年轻人vaping流行病，并将从根本上改变临床实践。

PROJECT SUMMARY/ABSTRACT The prevalence of adolescent nicotine vaping is rising more rapidly than any prior known drug. In some areas of the US, over one third of high school seniors vape nicotine regularly. This rapid rise in popularity of electronic nicotine delivery devices (ENDS, “e-cigarettes”, vapes) has reversed five decades of denormalizing youth tobacco use, putting adolescents at high risk for nicotine dependence, tobacco smoking, other drug use, and direct negative health effects of vapor exposure. While sensible regulation raising the purchasing age and eliminating sweet and mint flavors should curb new uptake of adolescent nicotine vaping among never smokers, these policies are causing many to seek vaping cessation treatment. There are an estimated one million adolescents in the US with an addiction to vaped nicotine. No treatment trials for vaping cessation have been published to date to our knowledge. Effective interventions are critical to aid the estimated one million US adolescents now with addiction to vaped nicotine to quit vaping and not start smoking. Varenicline, the most effective known smoking cessation medication, has been well tolerated and associated with significantly higher tobacco abstinence rates and faster time to abstinence in secondary outcomes in two recent small randomized controlled trials in adolescent smokers. In a recent series in our group, varenicline together with text vaping cessation support has been associated with 65% (34 of 52 patients) prolonged vaping abstinence rates (at 3-9 months follow up) in non-smoking adolescents who are dependent on vaped nicotine, while nicotine replacement therapy has been associated with approximately 21% abstinence rates to date in this population. In the current study, we propose to test whether varenicline, the most effective treatment known for nicotine addiction, helps nicotine dependent adolescents to quit vaping nicotine. To do so, we will enroll 300 adolescents, aged 16 - 20, who vape, are nicotine dependent, do not smoke, and want to quit. Adolescents will be recruited through high schools, colleges, and the community in Greater Boston, and those eligible will be enrolled into a double-blind, placebo-controlled, parallel group, intent-to-treat trial of varenicline up to 1 mg bid for 12 weeks added to an active behavioral control intervention involving 12 weeks of text messaging and group behavioral support specifically designed for teen vaping cessation. Medication adherence and trial retention, challenges in prior adolescent smoking cessation trials, will be incentivized and supported with the innovative AiCure smartphone application for remotely directly observed dosing and collection of daily vaping and other data. This proposal is responsive to urgent and growing requests for vaping cessation treatment for adolescents from patients, their families, and schools. Positive results will define an effective treatment that can be used in this rapidly moving epidemic of youth vaping, and will fundamentally change clinical practice.