近日，美国马萨诸塞州总医院Randi M. Schuster团队研究了伐尼克兰用于青少年戒烟的疗效与安全性。2025年4月23日出版的《美国医学会杂志》发表了这项成果。

在青少年和年轻人中使用电子烟（vaping）很常见。很少有治疗方法在这一人群中进行过测试。为了评价伐尼克兰对不经常吸烟的青少年戒烟的效果，研究组进行了一项3组随机临床试验，比较了12周的双盲伐尼克兰和安慰剂，都添加了每组简短的远程行为咨询，并与单盲增强常规护理进行了比较，每月随访至24周。该试验于2022年6月至2024年5月在美国一个州进行，试验对象是16至25岁的年轻人，他们每天或几乎每天吸尼古丁，不经常吸烟，并希望减少或戒掉电子烟。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12周的伐尼克兰，滴定至1mg，每天两次，持续7天（标准滴定），每周咨询，并转介到短信戒烟支持（TIQ） （n=88）；相同安慰剂，每周咨询，转介到TIQ (n = 87)；或加强常规护理（仅转介至TIQ） （n = 86）。主要结局为生物化学验证在最后4周伐尼克兰治疗和安慰剂治疗中连续戒烟。次要结局包括伐尼克兰组和安慰剂组从第9周到第24周的生物化持续戒断。额外的分析比较了伐尼克兰组和安慰剂组加强常规护理。

261名随机参与者（平均年龄21.4岁；53%为女性）中254例（97.3%）完成试验。对于伐尼克兰和安慰剂，第9至12周的持续戒断率分别为51%和14%（校正优势比[aOR]， 6.5；P <.001），第9至24周28% vs 7%（aOR, 6.0 [95% CI, 2.1-16.9]; P < .001） 。在第9至12周，伐尼克兰的持续戒断率高于常规护理（51% vs 6%；aOR, 16.9）和第9至24周（28% vs 4%；aOR, 11.0）。持续戒断率在安慰剂组和强化常规护理组之间没有显著差异。研究药物一般耐受良好。2名伐尼克兰参与者（2%）和1名安慰剂参与者（1%）因不良事件停止研究用药。未发生与药物相关的严重不良事件。治疗后出现的不良事件在伐尼克兰组有76例（86%），安慰剂组有68例（79%），强化常规护理组有68例（79%）。

研究结果表明，伐尼克兰与行为咨询相结合，提高了吸尼古丁但不经常吸烟的年轻人对电子烟的戒断程度。

附：英文原文

Title: Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial

Author: A. Eden Evins, Corinne Cather, Harrison T. Reeder, Bryn Evohr, Kevin Potter, Gladys N. Pachas, Kevin M. Gray, Sharon Levy, Nancy A. Rigotti, Vanessa Iroegbulem, Jason Dufour, Kelly Casottana, Meghan A. Costello, Jodi M. Gilman, Randi M. Schuster

Issue&Volume: 2025-04-23

Abstract:

Importance  Electronic cigarette use (vaping) among adolescents and young adults is common. Few treatments have been tested in this population.

Objective  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.

Interventions  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).

Main Outcomes and Measures  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.

Results  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.

Conclusions and Relevance  Varenicline, combined with behavioral counseling, increased vaping abstinence in youth who vape nicotine and do not regularly smoke tobacco.

DOI: 10.1001/jama.2025.3810

Source: https://jamanetwork.com/journals/jama/fullarticle/2833137