尼古丁口喷戒烟的疗效和安全性：自然环境下的一项随机、多中心、对照研究。

Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting.

机构信息

Los Angeles Clinical Trials, Burbank, CA.

McNeil AB, Helsingborg, Sweden.

出版信息

Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.

DOI:10.1093/ntr/nty246

PMID:30452732

Abstract

BACKGROUND

Nicotine replacement therapy (NRT) has been demonstrated to be an effective pharmacological treatment for smoking cessation, and most types of NRT have been approved as over-the-counter (OTC) medications. In an effort to create a fast-acting, flexible, and discreet NRT, a nicotine mouth spray (NMS) has been developed. This study was designed to assess the efficacy and safety of NMS in a naturalistic setting in the United States.

METHODS

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 26-week study in 1198 smokers motivated to quit. The study was designed to resemble an OTC environment, and thus included limited intervention, limited motivational screening, and no behavioral support. The primary efficacy endpoint was carbon monoxide-verified, self-reported continuous abstinence from smoking from week 2 until week 6. The safety of NMS was assessed by measuring vital signs, visual mouth inspection, and collection of subject-reported adverse events (AEs).

RESULTS

The percentage of subjects with carbon monoxide-verified continuous abstinence from week 2 to week 6 was statistically significantly greater in the NMS group compared with the placebo group (5.0% vs. 2.5%, p = .021). Statistically significant treatment effects for the NMS were maintained throughout the 26-week period. The study medications were generally well tolerated. The severity of AEs was similar for both treatment groups, and most AEs were of mild or moderate severity.

CONCLUSIONS

These study results demonstrate that the NMS is an effective and safe smoking cessation option for smokers motivated to quit, even in a naturalistic setting and without behavioral support.

IMPLICATIONS

This study demonstrated the safety, efficacy, and acceptability of an NMS in an OTC environment with no behavioral counseling or support. It provides an additional option for smokers motivated to quit.

TRIAL REGISTRATION

ClinicalTrials.gov (number NCT02355665).

摘要

背景

尼古丁替代疗法（NRT）已被证明是一种有效的戒烟药物治疗方法，大多数类型的 NRT 已被批准为非处方（OTC）药物。为了开发一种起效快、灵活且隐蔽的 NRT，开发了尼古丁口腔喷雾（NMS）。这项研究旨在评估 NMS 在自然环境下的有效性和安全性。

方法

这是一项多中心、随机、双盲、安慰剂对照、平行组、26 周的研究，共纳入了 1198 名有戒烟意愿的吸烟者。该研究旨在模拟 OTC 环境，因此干预措施有限，动机筛查有限，没有行为支持。主要疗效终点是通过一氧化碳验证的，从第 2 周到第 6 周自我报告的连续戒烟。通过测量生命体征、口腔目视检查和收集受试者报告的不良事件（AE）来评估 NMS 的安全性。