Varenicline Over-The-Counter Trial on Efficacy and Safety.

IF 3 2区医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Nicotine & Tobacco Research Pub Date : 2024-12-23 DOI:10.1093/ntr/ntae172

Jennifer Pearson, Mitchell A Nides, Alana Cataldo, Marisol Martinez, Jackie Morales, Ryan Seltzer, Jonathan Kurka, Matthew Broussard, Scott J Leischow

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引用次数: 0

Abstract

Introduction: Varenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently, in the United States, varenicline is not available over the counter (OTC).

Aims and methods: In this study, we assessed the safety and efficacy of 1 mg and 0.5 mg varenicline as an OTC medication for smoking cessation in comparison to placebo. This randomized, double-blind, placebo-controlled study was performed at two clinical sites in the United States of n = 313 people. The treatment period was 12 weeks. During the COVID pandemic, the protocol was modified to allow remote participation; verification of smoking status was via breath carbon monoxide levels for in-person visits and mailed urine cotinine kits for the remote participants.

Results: There was no difference in biologically confirmed continuous abstinence by condition between weeks 8 and 12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1 mg b.i.d. condition than for those in the placebo condition at week 12 (OR 3.39; 95% CI 1.49, 7.71), and were higher for those assigned to the 1.0 mg b.i.d. condition than the 0.5 mg b.i.d. condition at week 12 (OR 2.37; 95% CI 1.11, 5.05). Adverse events were modest, and as expected (vivid dreams and nausea in the medication conditions).

Conclusions: The results are suggestive that varenicline is safe and effective as an OTC medication.

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伐伦克兰非处方药物疗效和安全性试验。

简介伐尼克兰对吸烟者的戒烟率是安慰剂的 2-3 倍。目前，伐尼克兰在美国还没有非处方药（OTC）。在这项研究中，我们评估了 1 毫克和 0.5 毫克伐尼克兰作为戒烟非处方药与安慰剂相比的安全性和有效性：这项随机、双盲、安慰剂对照研究在美国的两个临床基地进行，人数为313人。治疗期为 12 周。在 COVID 大流行期间，对方案进行了修改，允许远程参与；对亲临现场的参与者，通过呼气一氧化碳水平验证吸烟状态，对远程参与者，通过邮寄的尿可替宁试剂盒验证吸烟状态：结果：在第 8-12 周期间，经生物学证实的持续戒烟率没有差异；但是，经生物学证实的点戒烟率，1 毫克每天服用一次的戒烟者高于安慰剂戒烟者。然而，在第 12 周时，1 毫克基础剂量条件下的患者比安慰剂条件下的患者有更高的生物证实点戒断几率（OR 3.39；95% CI 1.49，7.71），在第 12 周时，分配到 1.0 毫克基础剂量条件下的患者比分配到 0.5 毫克基础剂量条件下的患者有更高的生物证实点戒断几率（OR 2.37；95% CI 1.11，5.05）。不良反应并不严重，符合预期（用药情况下出现多梦和恶心）：结果表明，作为一种非处方药，伐尼克兰是安全有效的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nicotine & Tobacco Research 医学-公共卫生、环境卫生与职业卫生

CiteScore

8.10

自引率

10.60%

发文量

268

审稿时长

3-8 weeks

期刊介绍： Nicotine & Tobacco Research is one of the world''s few peer-reviewed journals devoted exclusively to the study of nicotine and tobacco. It aims to provide a forum for empirical findings, critical reviews, and conceptual papers on the many aspects of nicotine and tobacco, including research from the biobehavioral, neurobiological, molecular biologic, epidemiological, prevention, and treatment arenas. Along with manuscripts from each of the areas mentioned above, the editors encourage submissions that are integrative in nature and that cross traditional disciplinary boundaries. The journal is sponsored by the Society for Research on Nicotine and Tobacco (SRNT). It publishes twelve times a year.