Status:
COMPLETED
Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients With Pulmonary Tuberculosis
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
University of Cape Town
Sri Venkateswara Institute of Medical Sciences University
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 cli...
Detailed Description
No clinical trials have been done to determine if the cessation of smoking has any influence on outcome in tuberculosis patients. In particular, if smoking cessation leads to a higher rate of sputum c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01517022
Start Date
November 1 2010
End Date
September 1 2016
Last Update
October 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All India Institute of Medical Sciences, Ansari Nagar
New Delhi, India, 110029