Tuberculosis (TB) and tobacco

Not Applicable

Completed

• Conditions: Smoking cessation in pulmonary TB patients; Not Applicable

• Registration Number: ISRCTN43811467
• Lead Sponsor: niversity of York (UK)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29602847 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33069301/ results (added 20/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33841063/ nested study results (added 13/04/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36028279/ Cost-utility results (added 30/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-31
• Study Completion: 2019-10-31
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2472

Inclusion Criteria

Current inclusion criteria as of 04/09/2017:
1. Age at least 15 years (counted as adult TB patients in Pakistan) and 18 years in Bangladesh
2. Able to provide consent
3. Diagnosed with pulmonary tuberculosis (PTB) (smear positive or negative) in the last four weeks
4. Currently smokes tobacco
5. Willing to quit tobacco use

Previous inclusion criteria:
1. Age at least 15 years (counted as adult TB patients in Pakistan and Bangladesh) and at least 18 years in Nepal
2. Able to provide consent
3. Diagnosed with pulmonary tuberculosis (PTB) (smear positive or negative) in the last four weeks
4. Currently smokes tobacco
5. Willing to quit tobacco use

Exclusion Criteria

Patients anticipated to have adverse effects either due to the study treatment or research burden, will be excluded. These will include those who are/have:
1. Retreatment TB, MDR TB, Miliary or Extra-pulmonary TB
2. Currently receiving Streptomycin (Category II anti-TB medication) and/or Para Amino Salicylic Acid (PASA)
3. Currently using any pharmacotherapy for tobacco dependence
4. Pregnant, lactating, or planning to become pregnant
5. Had myocardial infarction, stroke, or an attack of severe angina within the previous two weeks
6. Uncontrolled high blood pressure despite being on medication
7. Severe renal impairment (requiring dialysis)
8. Suffering from schizophrenia or known to be diagnosed with epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified