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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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Title: 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.
Authors: Dogar, Omara, Barua, Deepa, Boeckmann, Melanie, Elsey, Helen, Fatima, Razia, Gabe, Rhian, Huque, Rumana, Keding, Ada, Khan, Amina, Kotz, Daniel, Kralikova, Eva, Newell, James N., Nohavova, Iveta, Parrott, Steve, Readshaw, Anne, Renwick, Lottie, Sheikh, Aziz, Siddiqi, Kamran, on behalf of the TB and Tobacco project consortium
Source: Addiction. Sep2018, Vol. 113 Issue 9, p1716-1726. 12p. 1 Diagram, 7 Charts.
Subjects: Cytisine, Smoking cessation, Medication safety, Tuberculosis patients, Cost effectiveness, Treatment effectiveness, Blind experiment, Substance abuse, Safety, Equipment & supplies, Therapeutic use of alkaloids, Tuberculosis diagnosis, Alkaloids, Drug addiction, Drug withdrawal symptoms, Medical care, Medical cooperation, Medical protocols, Nicotine, Health outcome assessment, Public health, Research, Time, Tuberculosis, Disease relapse, Social support, Randomized controlled trials, Middle-income countries, Low-income countries
Geographic Terms: Bangladesh, Pakistan
Abstract: 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. [ABSTRACT FROM AUTHOR]
Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: 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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  Data: <searchLink fieldCode="JN" term="%22Addiction%22">Addiction</searchLink>. Sep2018, Vol. 113 Issue 9, p1716-1726. 12p. 1 Diagram, 7 Charts.
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  Data: <searchLink fieldCode="DE" term="%22Bangladesh%22">Bangladesh</searchLink><br /><searchLink fieldCode="DE" term="%22Pakistan%22">Pakistan</searchLink>
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Addiction is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1111/add.14242
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      – Code: eng
        Text: English
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      – SubjectFull: Cytisine
        Type: general
      – SubjectFull: Smoking cessation
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      – SubjectFull: Medication safety
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      – SubjectFull: Pakistan
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