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 randomised trial

TB & Tobacco project consortium, 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

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND AND AIMS: Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. 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 randomised trial.

SETTING: TB treatment centres integrated into public health care systems in Bangladesh and Pakistan.

PARTICIPANTS: Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388).

MEASUREMENTS: The primary outcome measure is biochemically verified continuous abstinence from smoking at six 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 tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke.

Original languageEnglish
JournalAddiction
Early online date20 Apr 2018
DOIs
Publication statusE-pub ahead of print - 20 Apr 2018

Keywords

  • Journal Article

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