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Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

Primary Purpose

Tuberculosis, Pulmonary

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Bupropion

Behavioural Change Communication

About this trial

This is an interventional supportive care trial for Tuberculosis, Pulmonary focused on measuring smoking cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Bupropion

Behavioural Change Communication

Control

Arm Description

Outcomes

Primary Outcome Measures

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..

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04848246

First Posted

April 4, 2021

Last Updated

April 13, 2021

Sponsor

Dow University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04848246

Brief Title

Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 6, 2017 (Actual)

Primary Completion Date

September 30, 2019 (Actual)

Study Completion Date

October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis, Pulmonary

Keywords

smoking cessation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A total of three groups, two intervention and one control

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bupropion

Arm Type

Experimental

Arm Title

Behavioural Change Communication

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Bupropion

Intervention Description

This group received Bupropion 150 mg twice daily for 10 weeks

Intervention Type

Behavioral

Intervention Name(s)

Behavioural Change Communication

Intervention Description

This group will receive Behavioural Change Communication

Primary Outcome Measure Information:

Title

Percentage of patients completing anti-tuberculosis treatment

Description

Time Frame

six months

Secondary Outcome Measure Information:

Title

Percentage of participants achieving abstinence from smoking

Description

Time Frame

six months

Other Pre-specified Outcome Measures:

Title

Percentage of patients defaulting anti-tuberculosis treatment.

Description

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.

Time Frame

Six Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Tahir Rizwan Khan, M.Phil.

Organizational Affiliation

Dow University of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dow University of Health Sciences

City

Karachi

State/Province

Sindh

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

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