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

NCT01517022 | Completed Phase 3 DMC

• 1 other identifier: SKS/Med/NI1161
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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 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

Conditions

Tuberculosis

Keywords

smoking cessation; early sputum smear conversion

Outcome Measures

Primary Outcomes (2)

• 1. Change in TB Score at second month and sixth month

  Composite score for objective and subjective improvement measured at baseline, second month and sixth month

  Measured at baseline, second month and sixth month.

• Sputum culture conversion

  Sputum culture conversion at second month using solid/liquid culture technique

  Measured at baseline and second month

Secondary Outcomes (6)

• Sputum smear conversion

  Measured at baseline, second week, fourth week, second month and sixth months

• Mortality at sixth month

  Sixth month

• More than 10% weight gain at six months

  Sixth month

• Proportion of subjects in each group that have quit smoking at second month

  Sixth month

• Treatment completion

  Six months for new cases and eight months for re-treatment cases following regimen 2

Study Arms (2)

Control arm

NO INTERVENTION

Control arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along with routine DOTS treatment

Intervention arm

ACTIVE COMPARATOR

Cessation arm patients will receive pre designed pamphlets and structured conselling for smoking cessation by trained counsellors along and nicotine replacement therapy(NRT) and routine DOTS treatment

Drug: nicotine replacement therapy

Interventions

nicotine replacement therapy DRUG

nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks

Also known as: Nicogum 2mg Cipla pharmaceuticals

Intervention arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• University of Cape Town: collaborator
• Sri Venkateswara Institute of Medical Sciences University: collaborator

Study Sites (1)

All India Institute of Medical Sciences, Ansari Nagar

New Delhi, 110029, India

Location

Related Publications (1)

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Tuberculosis; Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Surendra K Sharma, MD, Ph.D.

  AIIMS, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: January 25, 2012
• Study Start: November 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

IN (1)