Design Plan for a Two-Group Randomized Trial of THR Products in Economically Developing Areas

Abstract

As a result of increasing tobacco smoking, LMICs may account for a disproportionately high number of deaths caused by tobacco use worldwide. In order to deploy tobacco harm reduction (THR) products as an effective smoking cessation approach to limit escalating tobacco use in LMICs, it is vital to understand and perform RCTs in this setting. In this randomized controlled trial (RCT), 258 adult smokers will participate over the course of 52 weeks; each arm will get a 12-week treatment and a 12-week follow-up period. After participants fulfill the requirements and provide their informed permission, they will be randomly assigned to one of two treatment groups: (1) e-cigarettes with individual counseling and a nicotine patch dose of 21 mg or (2) nicotine patches with individual counseling and a nicotine concentration of 18 mg/ml. Both a screening and a baseline (BL) visit will be planned for participants at the trial location. A total of eight study visits, comprising five treatment sessions and three follow-up visits, will be arranged for the participants. These visits will include both in-person contacts at the trial site and telephone follow-up. In all, eight visits are scheduled for weeks 1, 2, 4, 8, 12, 18, 24, and 52. For the purpose of quantifying biochemically confirmed smoking abstinence, the trial site will use exhaled carbon monoxide evaluation.