- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04848246
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
-
-
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
|
This group received Bupropion 150 mg twice daily for 10 weeks
This group will receive Behavioural Change Communication
|
EXPERIMENTAL: 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.
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
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Pulmonary
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
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.
Clinical Trials on Tuberculosis, Pulmonary
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
Tjip van der WerfGadjah Mada University; The Enose Company, Zutphen the NetherlandsCompletedPulmonary Tuberculosis Suspected | Other Specified Chronic Obstructive Pulmonary Disease | Pulmonary Tuberculosis TB (+) Histology, (-) BacteriologyIndonesia
-
Research Institute of Epidemiology, Microbiology...Active, not recruitingAspergillosis | Pulmonary Tuberculoses | Old Tuberculosis | Active Tuberculosis | Chronic Pulmonary AspergillosisUzbekistan
-
Medecins Sans Frontieres, NetherlandsLondon School of Hygiene and Tropical Medicine; University of Liverpool; Ministry... and other collaboratorsRecruitingMulti-drug Resistant Tuberculosis | Pulmonary Tuberculoses | Extensively Drug-Resistant TuberculosisBelarus, South Africa, Uzbekistan
-
Radboud University Medical CenterEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Department... and other collaboratorsCompletedPulmonary Tuberculosis (TB)South Africa
-
National Institute of Allergy and Infectious Diseases...International Tuberculosis Research CenterWithdrawnRefractory Pulmonary TuberculosisKorea, Republic of
-
Assiut UniversityUnknownExtra Pulmonary Tuberculosis
-
Karolinska InstitutetAddis Ababa University; Armauer Hansen Research Institute, EthiopiaCompleted
-
Michael HoelscherRadboud University Medical Center; German Federal Ministry of Education and... and other collaboratorsCompletedPulmonary Tuberculoses | Other Specified Pulmonary TuberculosisSouth Africa
Clinical Trials on Bupropion
-
Orexigen Therapeutics, IncCompleted
-
University of Rochester NCORP Research BaseNational Cancer Institute (NCI)RecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
Altschuler, Eric, M.D.GlaxoSmithKlineCompleted
-
Mayo ClinicNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Alembic Pharmaceuticals Ltd.CompletedBioequivalenceCanada
-
University of Wisconsin, MadisonNational Institutes of Health (NIH)Completed
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingCigarette Smoking-Related CarcinomaUnited States
-
GlaxoSmithKlineCompleted
-
National Institute on Drug Abuse (NIDA)CompletedTobacco Use Disorder | Tobacco Use CessationUnited States
-
National Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Tobacco Use DisorderUnited States