Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

April 13, 2021 updated by: Muhammad Tahir Rizwan Khan, Dow University of Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Bupropion
Drug: Bupropion
This group received Bupropion 150 mg twice daily for 10 weeks
Behavioral: Behavioural Change Communication
This group will receive Behavioural Change Communication
EXPERIMENTAL: Behavioural Change Communication
Behavioral: Behavioural Change Communication
This group will receive Behavioural Change Communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients completing anti-tuberculosis treatment
Time Frame: 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..
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving abstinence from smoking
Time Frame: 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.
six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients defaulting anti-tuberculosis treatment.
Time Frame: 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.
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Muhammad Tahir Rizwan Khan, M.Phil., Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2017

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

October 15, 2019

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (ACTUAL)

April 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-898/DUHS/Approval/2017/136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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