A Randomized Trial Protocol to Determine Effectiveness of Nicotine Replacement Therapy on Smoking Cessation of Tuberculosis Patients in Coastal India

Abstract

Background: Tobacco smoking and pulmonary tuberculosis combined is two preventable public health concerns. They put the annual global death rates from these two diseases at over six million. There is tangible evidence from studies conducted on more than forty thousand patients regarding nicotine therapy for tobacco smokers enhances likelihood of success when compared to support without nicotine replacement. This study determines the effectiveness of nicotine replacement therapy among tuberculosis patients.

Methods: This protocol study determines the effectiveness of tobacco smoking cessation rates among pulmonary tuberculosis patients on nicotine replacement treatment. The secondary objectives are to determine the relationship between smoking cessation and tuberculosis treatment outcome and the determinants of smoking cessation. This CONSORT 2010 checklist-based, placebo controlled, block- randomized, double-arm, single blind trial will be experimented between March 2019 and August 2022 in Mangaluru, India, with a sample size of 300 in both the arms. The intervention group will be prescribed with nicotine polacrilex chewing gums along with brief advice and the control group with brief advice and sugar-free chewing gum as a placebo for three months in a tapered dose with 3 months of follow-up. The binary outcome of reported status of smoking the participants will be confirmed by urine cotinine qualitative test at the start and end of the trial apart from monthly carbon monoxide monitoring and Fagerstorm scoring. Ethical clearance is obtained from Nitte University.

Discussion: The collected information will be summarized by using frequencies and percentages for qualitative data, mean and standard deviation for quantitative data. To compare the outcome measures, quantitative, before and after intervention, paired-t test will be used. 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. The significance of this study is to gather further evidence nicotine replacement therapy as an appropriate technology in primary care settings and further upwards by conducting the trial in actual healthcare settings.

Trial registration: The trial is registered prospectively with the Clinical Trials Registry of India vide CTRI/2018/11/016457 dated 28/11/2018.