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Completed

NCT Number: NCT04848246

Effect of Smoking Cessation on Tuberculosis Treatment Outcomes

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

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Gram-Positive Bacterial Infections Health Behavior Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Smoking Cessation Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupropion

Drug

This group received Bupropion 150 mg twice daily for 10 weeks

Behavioural Change Communication

Behavioral

This group will receive Behavioural Change Communication

Primary outcomes

  1. 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..

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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