Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes.

Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Sri Venkateswara Institute of Medical Sciences University; University of Cape Town
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• any adult (> 18 years)

• Recently diagnosed (primary TB/Relapse TB) smear-positive TB patient who self-reports to smoke at least 10 whole cigarettes or bidis (rolled tobacco leaf) per day, every day

Exclusion Criteria:

• patients will be excluded from recruitment to the study if they fall into any one or more of these exclusion categories:

• Inability to give consent or < 18 years

• Patients who self-report to smoke less than 10 whole cigarettes/bidis per day

• TB patients who have already started anti-tuberculosis therapy for more than 1 week.

• Patients with known multidrug-resistant TB (or XDR) (information provided by patient or the information is available in the clinic folder).

• Known HIV-positive patients

• Contra-indications to NRT (patients with a history of severe cardiovascular disease including arrhythmias, recent myocardial infarction (within the last 6 months), recent cerebrovascular incident (6 months), and/ or history of peripheral vascular disease, phaeochromocytoma, poorly controlled diabetes mellitus, hyperthyroidism, renal/hepatic impairment or gastritis/peptic ulcers). Patients with asthma or depression will also be excluded, as quitting may have an effect on medications used for these conditions. Patients with severe skin disorders (such as psoriasis or eczema) will also be excluded.