Evins A Eden, Cather Corinne, Reeder Harrison T, Evohr Bryn, Potter Kevin, Pachas Gladys N, Gray Kevin M, Levy Sharon, Rigotti Nancy A, Iroegbulem Vanessa, Dufour Jason, Casottana Kelly, Costello Meghan A, Gilman Jodi M, Schuster Randi M
Center for Addiction Medicine, Department of Psychiatry, Massachusetts General Hospital, Boston.
Harvard Medical School, Boston, Massachusetts.
JAMA. 2025 Apr 23. doi: 10.1001/jama.2025.3810.
Electronic cigarette use (vaping) among adolescents and young adults is common. Few treatments have been tested in this population.
To evaluate the efficacy of varenicline for nicotine vaping cessation in youth who do not smoke tobacco regularly.
DESIGN, SETTING, AND PARTICIPANTS: A 3-group randomized clinical trial compared 12 weeks of double-blind varenicline vs placebo, each added to brief, remotely delivered behavioral counseling and compared with single-blind enhanced usual care, with monthly follow-up to 24 weeks. The trial was conducted among youth, aged 16 to 25 years, who vaped nicotine daily or near daily, did not regularly smoke tobacco, and wanted to reduce or quit vaping, in a single US state from June 2022 to May 2024. Data collection ended May 28, 2024.
Participants were randomized (1:1:1) to 12 weeks of varenicline titrated to 1 mg twice daily over 7 days (standard titration), weekly counseling, and referral to text messaging vaping cessation support (This is Quitting [TIQ]) (n = 88); identical placebo, weekly counseling, and referral to TIQ (n = 87); or enhanced usual care (referral to TIQ only) (n = 86).
Biochemically verified continuous vaping abstinence for the last 4 weeks of varenicline treatment vs placebo (primary outcome). Secondary outcomes included bioverified continuous abstinence from weeks 9 through 24 in the varenicline and placebo groups. Additional analyses compared varenicline group and placebo group with enhanced usual care.
Of 261 randomized participants (mean age, 21.4 years; 53% female), 254 completed the trial (97.3%). For varenicline and placebo, continuous abstinence rates were 51% vs 14% during weeks 9 through 12 (adjusted odds ratio [aOR], 6.5 [95% CI, 3.0-14.1]; P < .001) and 28% vs 7% during weeks 9 through 24 (aOR, 6.0 [95% CI, 2.1-16.9]; P < .001). Varenicline had higher continuous abstinence rates vs enhanced usual care during weeks 9 through 12 (51% vs 6%; aOR, 16.9 [95% CI, 6.2-46.3]) and during weeks 9 through 24 (28% vs 4%; aOR, 11.0 [95% CI, 3.1-38.8]). Continuous abstinence rates were not significantly different between the placebo and enhanced usual care groups. Study medication was generally well tolerated. Two varenicline participants (2%) and 1 placebo participant (1%) discontinued study medications due to adverse events. No drug-related serious adverse events occurred. Treatment-emergent adverse events were reported by 76 (86%) in the varenicline group, 68 (79%) in the placebo group, and 68 (79%) in the enhanced usual care group.
Varenicline, combined with behavioral counseling, increased vaping abstinence in youth who vape nicotine and do not regularly smoke tobacco.
ClinicalTrials.gov Identifier: NCT05367492.
青少年和年轻人中使用电子烟（吸电子烟）的现象很常见。针对这一人群的治疗方法很少经过测试。
评估伐尼克兰对不经常吸烟的年轻人戒烟的疗效。
设计、地点和参与者：一项三组随机临床试验比较了12周的双盲伐尼克兰与安慰剂，每种药物均添加简短的远程行为咨询，并与单盲强化常规护理进行比较，每月随访至24周。该试验于2022年6月至2024年5月在美国一个州对年龄在16至25岁之间、每天或几乎每天吸尼古丁电子烟、不经常吸烟且希望减少或戒掉吸电子烟习惯的年轻人进行。数据收集于2024年5月28日结束。
参与者被随机分配（1:1:1）至接受12周的伐尼克兰治疗，在7天内滴定至每日两次，每次1毫克（标准滴定），每周接受咨询，并转介至短信戒烟支持服务（“这就是戒烟”[TIQ]）（n = 88）；相同的安慰剂、每周咨询以及转介至TIQ（n = 87）；或强化常规护理（仅转介至TIQ）（n = 86）。
伐尼克兰治疗的最后4周与安慰剂相比，经生化验证的持续戒断吸电子烟情况（主要结局）。次要结局包括伐尼克兰组和安慰剂组在第9周至24周期间经生物验证的持续戒断情况。额外分析比较了伐尼克兰组和安慰剂组与强化常规护理的情况。
在261名随机分组的参与者中（平均年龄21.4岁；53%为女性），254人完成了试验（97.3%）。对于伐尼克兰和安慰剂，在第9周至12周期间，持续戒断率分别为51%和14%（调整后的优势比[aOR]，6.5[95%置信区间，3.0 - 14.1]；P <.001），在第9周至24周期间分别为28%和7%（aOR，6.0[95%置信区间，2.1 - 16.9]；P <.001）。在第9周至12周期间，伐尼克兰组的持续戒断率高于强化常规护理组（51%对6%；aOR，16.9[95%置信区间，6.2 - 46.3]），在第9周至24周期间也是如此（28%对4%；aOR，11.0[95%置信区间，3.1 - 38.8]）。安慰剂组和强化常规护理组之间的持续戒断率没有显著差异。研究药物总体耐受性良好。两名伐尼克兰组参与者（2%）和一名安慰剂组参与者（1%）因不良事件停止了研究药物治疗。未发生与药物相关的严重不良事件。伐尼克兰组有76人（86%）、安慰剂组有68人（79%）、强化常规护理组有68人（79%）报告了治疗中出现的不良事件。
伐尼克兰与行为咨询相结合，提高了吸尼古丁电子烟且不经常吸烟的年轻人的戒断率。
ClinicalTrials.gov标识符：NCT05367492。
