Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

NCT04848246 | Completed

• 1 other identifier: IRB-898/DUHS/Approval/2017/136
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis, Pulmonary

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of participants achieving abstinence from smoking

  six months

Other Outcomes (1)

• Percentage of patients defaulting anti-tuberculosis treatment.

  Six Months

Study Arms (3)

Bupropion

EXPERIMENTAL

Drug: Bupropion; Behavioral: Behavioural Change Communication

Behavioural Change Communication

EXPERIMENTAL

Behavioral: Behavioural Change Communication

Control

NO INTERVENTION

Interventions

Bupropion DRUG

This group received Bupropion 150 mg twice daily for 10 weeks

Bupropion

Behavioural Change Communication BEHAVIORAL

This group will receive Behavioural Change Communication

Behavioural Change Communication; Bupropion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Muhammad Tahir Rizwan Khan, M.Phil.

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor for tuberculosis outcomes at the study site were blinded in terms of intervention allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A total of three groups, two intervention and one control

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 19, 2021
• Study Start: November 6, 2017
• Primary Completion: September 30, 2019
• Study Completion: October 15, 2019
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)