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

TY - JOUR

T1 - 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

AU - Dogar, Omara Fatima

AU - Barua, Deepa

AU - Boeckmann, Melanie

AU - Elsey, Helen

AU - Fatima, Razia

AU - Gabe, Rhian

AU - Huque, Rumana

AU - Keding, Ada

AU - Khan, Amina

AU - Kotz, Daniel

AU - Kralikova, Eva

AU - Newell, James N

AU - Nohavova, Iveta

AU - Parrott, Steven James

AU - Readshaw, Anne Elizabeth

AU - Renwick, Charlotte

AU - Sheikh, Aziz

AU - Siddiqi, Kamran

N1 - © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

PY - 2018/4/20

Y1 - 2018/4/20

N2 - 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.

AB - 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.

KW - Bangladesh

KW - Pakistan

KW - cytisine

KW - low- and-middle income countries

KW - placebo-controlled randomized trial

KW - smoking cessation

KW - tobacco cessation

KW - tuberculosis

UR - http://www.scopus.com/inward/record.url?scp=85047790102&partnerID=8YFLogxK

U2 - 10.1111/add.14242

DO - 10.1111/add.14242

M3 - Article

SN - 0965-2140

VL - 113

SP - 1716

EP - 1726

JO - Addiction

JF - Addiction

IS - 9

ER -