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A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes

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Johns Hopkins University

Status

Completed

Conditions

Tuberculosis
Smoking Cessation

Treatments

Other: Intensive anti-smoking counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02238405
IRB00037636

Details and patient eligibility

About

The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.

Enrollment

350 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males, ≥18 years of age
  • diagnosed with pulmonary TB
  • self-reported current smokers, or smoker within 6 months
  • anticipated to be attending the TB treatment clinic for at least 6 months
  • be willing to set a quit date within 2 weeks after baseline assessment
  • agree to participate

Exclusion criteria

  • less than 18 years of age
  • quit for more than 6 months
  • extra-pulmonary TB
  • unable/unwilling to provide written consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

350 participants in 2 patient groups

Counseling
Experimental group
Description:
Intensive anti-smoking counseling
Treatment:
Other: Intensive anti-smoking counseling
Standard Care
No Intervention group
Description:
Control group will receive current standard of care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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