The safety,effectiveness and cost‐effectiveness of cytisine in achieving six‐month continuous smoking abstinence in tuberculosis patients—protocol for a double‐blind,placebo‐controlled randomized trial |
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| Authors: | Omara Dogar Deepa Barua Melanie Boeckmann Helen Elsey Razia Fatima Rhian Gabe Rumana Huque Ada Keding Amina Khan Daniel Kotz Eva Kralikova James N Newell Iveta Nohavova Steve Parrott Anne Readshaw Lottie Renwick Aziz Sheikh Kamran Siddiqi |
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| Institution: | 1. University of York, Department of Health Sciences, Faculty of Sciences, York, UK;2. ARK Foundation, Dhaka, Bangladesh;3. Institute of General Practice, Addiction Research and Clinical Epidemiology Unit, Medical Faculty of the Heinrich‐Heine‐University, Düsseldorf, Germany;4. University of Leeds, Leeds Institute of Health Sciences, Leeds, UK;5. National Tuberculosis Control Programme (NTP), Islamabad, Pakistan;6. Hull York Medical School, University of York, York, UK;7. Department of Economics, University of Dhaka, Bangladesh;8. The Initiative, Islamabad, Pakistan;9. University of Edinburgh, Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK;10. Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, the Netherlands;11. 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;12. Institute of Hygiene and Epidemiology, 1st Faculty of Medicine, Charles University and the University Hospital Prague, Czech Republic |
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| Abstract: | 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. |
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| Keywords: | Bangladesh cytisine low‐ and‐middle income countries Pakistan placebo‐controlled randomized trial smoking cessation tobacco cessation tuberculosis |
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