A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.
A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.
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DOI：
10.3389/fpsyt.2023.1083791
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发表时间：
2023
影响因子：
4.7
通讯作者：
Evins, A. Eden
中科院分区：
文献类型：
--
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
目前约有五分之一的高中生和大学生吸食尼古丁。青少年表达了戒烟的愿望，案例报告显示，通过行为和药物双重疗法，电子烟有望逐渐减少。然而，到目前为止，还没有公开发表的临床试验来测试这些干预方法对青少年尼古丁蒸发停止的影响。在这项三组随机、安慰剂对照、平行分组的研究中，我们的目标是评估varenicline与短暂的行为咨询和短信支持相结合对依赖蒸发尼古丁的青少年停止蒸发的疗效。这项研究将招募300名年龄在16-25岁之间、每天或几乎每天都吸食尼古丁的人，他们居住在大波士顿地区。参与者将被按1：1：1的比例随机分配，每组6个，每组1个：(1)为期12周的varenicline疗程，滴定至1 mg Bid，由非专业顾问提供简短的行为咨询，并介绍戒烟(TIQ)由真理倡议创建的短信支持；(2)为期12周的安慰剂疗程、简短的行为咨询和TIQ；以及(3)12周的强化日常护理，包括戒烟建议和TIQ入门。主要结果将是在治疗结束时(第12周)经过生化验证的持续汽化戒断。次要结果包括在随访时(第24周)持续戒断，在第12周和第24周连续戒断7天，在青少年蒸发人群中使用varenicline的安全性和耐受性，以及在整个干预期间情绪和尼古丁戒断症状的变化。探索性结果包括共病药物使用行为和尼古丁依赖的改变。分析将是意向治疗，对结果数据缺失或不完整的参与者进行多重归因敏感性分析。这是第一项评估varenicline与一种新颖的、简短的非专业顾问为吸食尼古丁的青少年提供的吸食戒烟计划相结合的研究。结果将使临床医生了解这一有希望但尚未测试的干预措施的有效性和可接受性。临床试验注册：ClinicalTrials.gov，标识NCT05367492。
Approximately one-fifth of high-school seniors and college students currently vape nicotine. Adolescents express a desire to quit vaping, and case reports have shown promise for e-cigarette tapering with dual behavioral and pharmacologic therapies. However, there are no published clinical trials to date that test these intervention approaches for adolescent nicotine vaping cessation. In this three-arm randomized, placebo-controlled, parallel-group study, we aim to assess the efficacy of varenicline in combination with brief behavioral counseling and texting support on vaping cessation in adolescents dependent on vaped nicotine. The study will enroll 300 individuals between the ages of 16–25 with daily or near-daily nicotine vaping who reside in the Greater Boston area. Participants will be randomly assigned in a 1:1:1 ratio in blocks of six to one of the three arms: (1) a 12-week course of varenicline titrated to 1 mg bid, brief behavioral counseling delivered by a lay counselor, and an introduction to This is Quitting (TIQ) texting support created by the Truth Initiative; (2) a 12-week course of placebo, brief behavioral counseling, and TIQ; and (3) 12 weeks of enhanced usual care, consisting of advice to quit and an introduction to TIQ. The primary outcome will be biochemically verified continuous vaping abstinence at the end of the treatment (week 12). Secondary outcomes include continuous abstinence at follow-up (week 24), 7-day point prevalence abstinence at weeks 12 and 24, safety and tolerability of varenicline in an adolescent vaping population, as well as change in mood and nicotine withdrawal symptoms across the intervention period. Exploratory outcomes include change in comorbid substance use behaviors and nicotine dependence. Analysis will be intent-to-treat, with multiple imputation sensitivity analyses for participants with missing or incomplete outcome data. This is the first study to evaluate varenicline in combination with a novel, brief, lay counselor delivered vaping cessation program for adolescents who vape nicotine. Results will inform clinicians on the effectiveness and acceptability of this promising, but not yet tested intervention. Clinical trial registration: ClinicalTrials.gov, identifier NCT05367492.
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影响因子：
36.4
作者：
Gray, Kevin M.;Rubinstein, Mark L.;McRae, Thomas D.
通讯作者：
McRae, Thomas D.
影响因子：
39
作者：
Graham AL;Amato MS;Cha S;Jacobs MA;Bottcher MM;Papandonatos GD
通讯作者：
Papandonatos GD
影响因子：
2.9
作者：
Evins, A. Eden;Benowitz, Neal L.;Anthenelli, Robert M.
通讯作者：
Anthenelli, Robert M.
影响因子：
3.5
作者：
Chadi, Nicholas;Hadland, Scott E.;Harris, Sion K.
通讯作者：
Harris, Sion K.
影响因子：
2.9
作者：
Faessel, Helene M.;Gibbs, Megan A.;Burstein, Aaron H.
通讯作者：
Burstein, Aaron H.