Strategies for smoking cessation (pharmacologic intervention versus enhanced motivation vs. standard motivation) in TB patients under treatment in the RNTCP, India - A cluster - Randomized trial.

Background: Tuberculosis burden is still high and smoking prevalence among males has increased in India. It is found that increased morbidity, mortality and relapse among TB smokers.

Method: Setting: Patients from two Revised National Tuberculosis Control Program Centres of Tamilnadu form the study population.

Objective: To compare the effectiveness of Bupropion therapy along with standard counselling versus enhanced counseling versus standard counseling for smoking cessation among TB patients.

Study Design: Cluster randomized effectiveness trial.

Procedure: Patients from each of the thirty-six Designated Microscopic Centres were randomly allocated to receive one of the three interventions using cluster randomization. Smoking cessation was assessed by self-reporting and confirmed by Carbon monoxide(CO) monitors, done at three-time points and TB treatment outcome at the end of ATT.

Results: Out of 517 male patients enrolled to the study, the smoking status is available only to 381 subjects. The proportion of patients who have quit smoking in drug, enhanced and standard arms at the end of treatment was 67%, 83% and 52% (P= < 0.001). There was no statistical significance in response to TB treatment between those who quit and those who did not (Favourable response 99.2% vs 97.6%).

Conclusion: Both enhanced counselling arm and drug arm are effective strategies for smoking cessation among TB patients and their implementation in the TB programs are recommended.