BACKGROUND: Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan. METHODS: We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete. FINDINGS: Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI -0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication. INTERPRETATION: Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis. FUNDING: European Union Horizon 2020 and Health Data Research UK. TRANSLATIONS: For the Bengali and Urdu translations of the abstract see Supplementary Materials section.

3rd Medical Department 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic; Institute of Hygiene and Epidemiology 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

ARK Foundation Dhaka Bangladesh

ARK Foundation Dhaka Bangladesh; Department of Economics University of Dhaka Dhaka Bangladesh

Centre for Cancer Prevention Wolfson Institute of Preventive Medicine Queen Mary University of London London UK

Common Management Unit Islamabad Pakistan

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

Department of Health Sciences Faculty of Sciences University of York York UK; Addiction Research and Clinical Epidemiology Unit Institute of General Practice Centre for Health and Society Heinrich Heine University Düsseldorf Germany; Department of Environment and Health School of Public Health Bielefeld University Bielefeld Germany

Department of Health Sciences Faculty of Sciences University of York York UK; Hull York Medical School University of York York UK

Department of Health Sciences Faculty of Sciences University of York York UK; Usher Institute University of Edinburgh Edinburgh UK

Institute of Psychiatry Rawalpindi Medical University Rawalpindi Pakistan

The Initiative Islamabad Pakistan

Usher Institute University of Edinburgh Edinburgh UK

Usher Institute University of Edinburgh Edinburgh UK; Addiction Research and Clinical Epidemiology Unit Institute of General Practice Centre for Health and Society Heinrich Heine University Düsseldorf Germany; Department of Family Medicine Care and Public Health Research Institute Maastricht University Maastricht Netherlands

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Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial

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ISRCTN
ISRCTN43811467