BACKGROUND AND AIMS: Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. In general populations, behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine-a low-cost plant-derived nicotine substitute-for smoking cessation in TB patients compared with placebo, over and above brief behavioural support. DESIGN: Two-arm, parallel, double-blind, placebo-controlled, multi-centre (30 sites in Bangladesh and Pakistan), individually randomized trial. SETTING: TB treatment centres integrated into public health care systems in Bangladesh and Pakistan. PARTICIPANTS: Newly diagnosed (in the last 4 weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n = 2388). MEASUREMENTS: The primary outcome measure is biochemically verified continuous abstinence from smoking at 6 months post-randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events. COMMENTS: This is the first smoking cessation trial of cytisine in low- and middle-income countries evaluating both cessation and TB outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke.

ARK Foundation Dhaka Bangladesh

Centre for Tobacco Dependent of the 3rd Medical Department Department of Endocrinology and Metabolism 1st Faculty of Medicine Charles University and the University Hospital Prague Czech Republic

Department of Economics University of Dhaka Bangladesh

Department of Family Medicine CAPHRI School for Public Health and Primary Care Maastricht University the Netherlands

Hull York Medical School University of York Heslington York UK

Institute of General Practice Addiction Research and Clinical Epidemiology Unit Medical Faculty of the Heinrich Heine University Düsseldorf Germany

Institute of Hygiene and Epidemiology 1st Faculty of Medicine Charles University and the University Hospital Prague Czech Republic

National Tuberculosis Control Programme Islamabad Pakistan

The Initiative Islamabad Pakistan

University of Edinburgh Usher Institute of Population Health Sciences and Informatics Edinburgh UK

University of Leeds Leeds Institute of Health Sciences Leeds UK

University of York Department of Health Sciences Faculty of Sciences York UK

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