Effectiveness of nicotine replacement therapy on smoking cessation among pulmonary tuberculosis patients of Mangaluru, India: A randomized controlled trial (Preprint)
UNSTRUCTURED Tuberculosis and tobacco smoking are two largely preventable public health concerns that independently pose a considerable threat to global health. The current estimates put the annual global mortality from the two epidemics at over six million. It is remarkable to note that TB and tobacco use are co-prevalent in many developing nations and these are said to be overburdened by the collision of the two epidemics. This study aims to determine the effectiveness of nicotine replacement therapy on smoking cessation among the pulmonary tuberculosis patients undergoing Directly Observed Therapy- Short Course. This is a randomized, placebo-controlled, two-arm, single blinded trial being conducted in Mangaluru, India. The total sample size including both the arms is 300. This study will be conducted between January 2019 and August 2020. Extra-pulmonary TB, smokeless tobacco users, patients with contraindications for NRT such as recent MI, angina pregnancy & lactation will be excluded from the study.Block Randomization will be done to obtain the two groups using a permuted The experimental group will be given nicotine replacement therapy and brief advice and the control group will be given brief advice and sugar-free chewing gum as a placebo for 3 months on a tapering dosage basis. The smoking status of the patients will be confirmed by urine cotinine test at the baseline and endline. Carbon monoxide monitoring and Fagerstom score will be recorded on a monthly basis.The participants will be followed for another 3 months to obtain a binary variable of smoking cessation status as "Quitter" or Non-quitter". The study also determines the TB outcome between tobacco quitters and non-quitters. Ethical clearance is obtained from the Institutional Ethics Committee of Nitte (deemed to be University) and the trial is registered with Clinical Trials Registry of India.