Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04848246

Enrollment

292

Registered

2021-04-19

Start date

2017-11-06

Completion date

2019-10-15

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pulmonary

Keywords

smoking cessation

Brief summary

This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients

Interventions

DRUGBupropion

This group received Bupropion 150 mg twice daily for 10 weeks

BEHAVIORALBehavioural Change Communication

This group will receive Behavioural Change Communication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcome assessor for tuberculosis outcomes at the study site were blinded in terms of intervention allocation

Intervention model description

A total of three groups, two intervention and one control

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* pulmonary tuberculosis patients of age 18 years or above * registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases * reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes

Exclusion criteria

* Extra pulmonary tuberculosis * drug resistant tuberculosis * pregnancy * positive history of epilepsy

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients completing anti-tuberculosis treatment	six months	Among both smear positive and smear negative TB patients, successful completion of ATT will be labeled at the end of 6 months period if the patients has been compliant with ATT through six months period..

Secondary

Measure	Time frame	Description
Percentage of participants achieving abstinence from smoking	six months	Abstinence is defined as staying away from smoking and it will be assessed at week 1, week 4, week 12 and week 24 will be assessed in following two ways: i. Self-reported abstinence using questionnaire ii. Expired carbon monoxide (eCO) levels using Micro Smokerlyzer (Bedfont Scientific) of less than 7 ppm.

Other

Measure	Time frame	Description
Percentage of patients defaulting anti-tuberculosis treatment.	Six Months	Treatment default will be defined as interruption of anti-tuberculosis treatment for ≥2 consecutive months. This outcome will be assessed in both smear positive and smear negative patients.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026