Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

• Sponsor: Dow University of Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04848246
• Collaborator: (none)
• Enrollment: 292
• Location: 1
• Arms: 3
• Actual Duration (Months): 23.3
• Patients Per Site Per Month: 12.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis, Pulmonary	Drug: Bupropion; Behavioral: Behavioural Change Communication	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 292 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A total of three groups, two intervention and one controlA total of three groups, two intervention and one control
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessor for tuberculosis outcomes at the study site were blinded in terms of intervention allocation
• Primary Purpose: Supportive Care
• Official Title: Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial
• Actual Study Start Date: Nov 6, 2017
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dow University of Health Sciences	Karachi	Sindh	Pakistan

Sponsors and Collaborators

• Dow University of Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Tahir Rizwan Khan, Assistant Professor, Dow University of Health Sciences
• ClinicalTrials.gov Identifier: NCT04848246
• Other Study ID Numbers: IRB-898/DUHS/Approval/2017/136
• First Posted: Apr 19, 2021
• Last Update Posted: Apr 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Muhammad Tahir Rizwan Khan, Assistant Professor, Dow University of Health Sciences: smoking cessation
• Additional relevant MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Bupropion

Study Results

No Results Posted as of Apr 19, 2021