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.

项目总结/文摘

项目成果

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

• DOI: 10.3389/fpsyt.2023.1083791
• 发表时间: 2023
• 期刊: FRONTIERS IN PSYCHIATRY
• 影响因子: 4.7
• 作者: Schuster, Randi M. M.;Cather, Corinne;Pachas, Gladys N. N.;Nielsen, Lindsay;Iroegbulem, Vanessa;Dufour, Jason;Potter, Kevin;Levy, Sharon;Gray, Kevin M. M.;Evins, A. Eden
• 通讯作者: Evins, A. Eden