Effectiveness of preloaded combination nicotine replacement therapy on smoking cessation of adult population in Kazakhstan- A randomized controlled trial

Collaborative Research Program for 2022-2024

Tobacco use is the world’s leading preventable cause of premature death and disease causing over 5 million deaths annually around the globe. Every year, more than 22500 of its people are killed by tobacco-caused diseases in Kazakhstan. Smoking abstinence significantly improves the health-related quality of life and therefore an effective cessation strategy is essential to improve the quit rates among the smokers. This study intends to determine the effectiveness of preloaded combination nicotine replacement therapy on smoking cessation.
Objectives:
• To determine the effectiveness of preloaded combination nicotine replacement therapy (NRT) on smoking cessation of tobacco smokers.
• To determine the predictors of smoking cessation among the study participants.
• To determine the change in health-related quality of life due to smoking cessation.
• To determine the perception of treatment adherence among the study participants.


Methodology:
This randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio will be conducted at the National research cardiac surgery Centre, Turan avenue, Nur-Sultan, Kazakhstan. The sample size is 100 each in the intervention and the control arm. The duration of treatment is 4 weeks preloading of combination nicotine replacement therapy followed by regular 12 weeks in the intervention arm and control arm has regular treatment without preloading. Primary outcome of the study is the abstinence at 12 months from the date of quit date in both the arms.
Results: The study shall adopt the “Intention to Treat Analysis” mechanism. If the study has missing data more than 10% of the total sample size as expected during sample size calculation, Pattern-Mixture Model within a mixed-effects logistic regression model for longitudinal dichotomous data will be used.
Conclusion: The study results shall add scientific evidence to the available literature about the preloaded combination nicotine replacement therapy being an effective intervention.