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

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

基本信息

批准号：
10298337
负责人：
A EDEN EVINS
金额：
$ 66.96万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
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/10298337
关键词：
Abstinence Address Adolescent Adverse event Advertising Age Alcohol consumption Area Attention Behavior Control Behavior Therapy Behavioral Boston Cannabis Clinic Collection Communities Controlled Study Cotinine Data Dependence Dose Double-Blind Method Drug Prescriptions Drug usage Electronic Nicotine Delivery Systems Electronic cigarette Enrollment Environment Epidemic Family Future Genus Mentha Harm Reduction Health Incentives Incidence Intervention Lead Literature Lung Modeling Monitor Nicotine Nicotine Dependence Nicotine Withdrawal Patients Pharmaceutical Preparations Pharmacotherapy Placebos Policies Population Positioning Attribute Prevalence Publishing Randomized Controlled Trials Regulation Relapse Reporting Risk Safety Schools Series Severities Signal Transduction Smoker Smoking Surveys Teenagers Testing Text Text Messaging Time Tobacco Tobacco smoke Tobacco smoking behavior Tobacco use Visit Withdrawal Symptom Youth addiction adolescent patient adolescent smoking adolescent substance use aged base cigarette smoking clinical care clinical practice college craving design early onset effective intervention effective therapy efficacy evaluation efficacy study follow-up high risk high school improved innovation medication compliance meetings mood symptom negative mood never smoker nicotine cessation nicotine replacement nicotine use non-smoker non-smoking placebo group randomized placebo controlled trial recruit remote delivery secondary outcome smartphone Application smoking cessation social media substance use tobacco abstinence tobacco products tobacco smokers treatment trial twelfth grade uptake vaper vaping vaping nicotine vapor varenicline

项目摘要

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.

项目概要/摘要在某些地区，青少年吸尼古丁电子烟的流行率上升速度比任何已知的药物都要快。在美国，超过三分之一的高中生经常吸食尼古丁，这种现象迅速流行。电子尼古丁输送装置（ENDS、“电子烟”、vapes）扭转了五年来的非正常化青少年吸烟，使青少年面临尼古丁依赖、吸烟、其他药物使用的高风险，以及蒸气暴露对健康的直接负面影响，同时合理的监管提高了购买年龄和消除甜味和薄荷口味应该可以抑制青少年对尼古丁电子烟的新吸收对于吸烟者来说，这些政策导致许多人寻求戒烟治疗。美国有 100 万青少年对电子烟上瘾，目前尚无戒烟治疗试验。据我们所知，有效的干预措施对于援助大约 100 万美国人至关重要。现在对电子烟上瘾的青少年要戒掉电子烟而不是开始吸烟。已知有效的戒烟药物，具有良好的耐受性，并且与显着升高相关最近两项小型随机研究中次要结果的戒烟率和更快的戒烟时间在我们小组最近的一系列对照试验中，伐尼克兰与文本电子烟一起使用。戒烟支持与 65%（52 名患者中的 34 名患者）长期戒烟率（3-9 几个月的随访）在依赖电子烟尼古丁的非吸烟青少年中，而尼古丁迄今为止，替代疗法与该人群中约 21% 的戒断率相关。在当前的研究中，我们建议测试伐尼克兰（varenicline）是否是已知的尼古丁最有效的治疗方法戒烟瘾，帮助尼古丁依赖青少年戒掉尼古丁电子烟。为此，我们将招募 300 名青少年。 16 - 20 岁吸电子烟的青少年对尼古丁有依赖性，不吸烟，并且想要戒烟。通过大波士顿地区的高中、大学和社区招募，符合条件的人将被参加一项双盲、安慰剂对照、平行组意向性治疗试验，伐尼克兰剂量高达 1 mg bid 为期 12 周的积极行为控制干预包括 12 周的短信和专门为青少年戒烟药物设计的团体行为支持和试验。保留，先前青少年戒烟试验中的挑战，将得到激励和支持创新的 AiCure 智能手机应用程序，用于远程观察剂量和收集每日电子烟数据该提案是为了响应日益增长的戒烟治疗请求。来自患者、其家庭和学校的青少年的积极结果将确定有效的治疗方法。可以用于这种快速发展的青少年电子烟流行病，并将从根本上改变临床实践。