Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848246
• Other study ID #: IRB-898/DUHS/Approval/2017/136
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: April 2021
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: October 15, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Bupropion
This group received Bupropion 150 mg twice daily for 10 weeks

Behavioral:
• Behavioural Change Communication
This group will receive Behavioural Change Communication

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients defaulting anti-tuberculosis treatment.	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.	Six Months
Primary	Percentage of patients completing anti-tuberculosis treatment	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..	six months
Secondary	Percentage of participants achieving abstinence from smoking	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.	six months