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

行政补充：伐尼克兰用于青少年非吸烟者戒烟尼古丁的随机对照试验

• 批准号: 10878378
• 负责人: A EDEN EVINS
• 金额: $ 16.62万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10878378
• 关键词: Abstinence; Administrative Supplement; Adolescent; Age; Behavior Control; Behavioral; Boston; Child; Collection; Communities; Data; Dose; Double-Blind Method; Drug usage; Electronic Nicotine Delivery Systems; Electronic cigarette; Eligibility Determination; Enrollment; Epidemic; Explosion; Exposure to; Family; Genus Mentha; Goals; Harm Reduction; Health; Incentives; Intervention; Marketing; Nicotine Dependence; Patients; Pharmaceutical Preparations; Placebo Control; Policies; Population; Prevalence; Publishing; Randomized, Controlled Trials; Regulation; Reporting; Schools; Series; Smoker; Smoking; Teenagers; Testing; Text; Text Messaging; Time; Tobacco smoke; Tobacco smoking behavior; Tobacco use; Youth; addiction; adolescent patient; adolescent smoking; aged; clinical care; clinical practice; college; design; effective intervention; effective therapy; follow-up; high risk; high school; innovation; medication compliance; never smoker; nicotine cessation; nicotine replacement; non-smoker; non-smoking; recruit; secondary outcome; smartphone application; smoking cessation; tobacco abstinence; tobacco products; tobacco smokers; treatment trial; twelfth grade; uptake; vaping; vaping nicotine; vapor; varenicline

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.

项目概要/摘要 青少年吸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 他们定期吸食尼古丁，电子尼古丁输送设备（ENDS，“电子- 香烟”（vapes）扭转了五年来青少年烟草使用非正常化的趋势，使青少年处于高位 尼古丁依赖、吸烟、使用其他药物的风险以及蒸气对健康的直接负面影响 合理的监管措施应该提高购买年龄并消除甜味和薄荷味。 为了遏制从不吸烟者中青少年吸食尼古丁电子烟，这些政策正在促使许多人寻求 迄今为止，我们尚未发布戒烟治疗的治疗试验。 有效的干预措施对于帮助现在对电子烟上瘾的青少年戒烟至关重要。 伐尼克兰是已知最有效的戒烟药物。 耐受性良好，与显着提高的戒烟率和更快的戒烟时间相关 在最近的一系列青少年吸烟者中进行的两项小型随机对照试验中的次要结果。 在我们的小组中，伐尼克兰和文字戒烟支持与 65% 的人相关（52 人中的 34 人 患者）长期不吸烟的青少年的电子烟戒断率（随访 3-9 个月） 依赖电子烟尼古丁，而尼古丁替代疗法与大约 21% 相关 迄今为止，该人群的戒断率在当前的研究中，我们建议测试伐尼克兰是否是一种有效的药物。 针对尼古丁成瘾最有效的治疗方法，帮助尼古丁依赖青少年戒掉电子烟 为此，我们将招募 300 名 16 至 25 岁的青少年，他们吸电子烟、不依赖尼古丁。 将通过高中、大学和社区招募吸烟并想戒烟的青少年。 大波士顿地区和符合条件的人将被纳入双盲、安慰剂对照、平行组， 在主动行为控制干预的基础上，进行为期 12 周的伐尼克兰意向治疗试验，每天两次服用 1 毫克 包括专为青少年电子烟设计的 12 周短信和团体行为支持 戒烟。药物依从性和试验保留，之前青少年戒烟试验中的挑战， 将通过创新的 EMocha 智能手机应用程序直接远程进行激励和支持 观察剂量并收集每日电子烟和其他数据。该提案是针对紧急和其他数据的响应。 患者、其家庭和学校对青少年戒烟治疗的要求越来越多。 积极的结果将确定一种有效的治疗方法，可用于这一快速蔓延的青少年流行病 电子烟将从根本上改变临床实践。

项目成果

A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.

一项针对青少年戒烟问题的伐尼克兰和简短行为咨询的随机对照试验：研究方案。

• 发表时间: 2023
• 作者: Schuster, Randi M;Cather, Corinne;Pachas, Gladys N;Nielsen, Lindsay;Iroegbulem, Vanessa;Dufour, Jason;Potter, Kevin;Levy, Sharon;Gray, Kevin M;Evins, A Eden
• 通讯作者: Evins, A Eden