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

项目总结/摘要 青少年尼古丁电子烟的流行率很高，超过三分之一的高中生报告说， 他们经常吸尼古丁电子尼古丁输送装置（ENDS，“电子尼古丁输送装置”）的迅速普及， 香烟”，vapes）已经扭转了50年来青少年烟草使用非正常化的趋势， 尼古丁依赖、吸烟、其他药物使用和蒸汽对健康的直接负面影响的风险 exposure.虽然提高购买年龄和消除甜味和薄荷味的合理规定应该 遏制从未吸烟者中青少年尼古丁vaping的新吸收，这些政策导致许多人寻求 vaping戒烟治疗。到目前为止，我们还没有发表关于戒烟的治疗试验。 知识有效的干预措施对于帮助现在对尼古丁成瘾的青少年戒烟至关重要 vaping电子烟and not start开始smoking吸烟.伐尼克兰是已知最有效的戒烟药物， 耐受性良好，与显著更高的戒烟率和更快的戒烟时间相关， 最近在青少年吸烟者中进行的两项小型随机对照试验的次要结局。在最近的一系列 在我们组中，伐尼克兰与文本vaping停止支持一起与65%（52例中的34例）相关 患者）在非吸烟青少年中的长期电子烟戒烟率（3-9个月随访） 依赖于尼古丁，而尼古丁替代疗法与大约21%的 到目前为止，这一人群的禁欲率。在目前的研究中，我们建议测试伐伦克林， 最有效的治疗尼古丁成瘾，帮助尼古丁依赖的青少年戒烟 尼古丁。要做到这一点，我们将招募300名青少年，年龄在16 - 25岁，谁vape，尼古丁依赖，不 吸烟，想戒烟。青少年将通过高中，大学和社区招募， 大波士顿，那些符合条件的将被招募到一个双盲，安慰剂对照，平行组， 一项在主动行为控制干预的基础上增加伐尼克兰（1 mg bid，持续12周）的意向治疗试验 包括12周的短信和专门为青少年vaping设计的群体行为支持 停止药物依从性和试验保留，既往青少年戒烟试验中的挑战， 我们将通过创新的EMocha智能手机应用程序， 观察剂量和收集每日vaping和其他数据。这一建议是对紧急和 越来越多的青少年患者，他们的家人和学校要求停止使用vaping治疗。 积极的结果将确定一种有效的治疗方法，可用于这一迅速蔓延的青年流行病 这将从根本上改变临床实践。

PROJECT SUMMARY/ABSTRACT The prevalence of adolescent nicotine vaping is high with over one third of high school seniors reporting that they 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. No treatment trials for vaping cessation have been published to date to our knowledge. Effective interventions are critical to aid 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 - 25, 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 EMocha 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.