Smoking CessationNCT02238405
A Controlled Smoking Cessation Trial and Prospective Cohort Study of Tuberculosis (TB) Treatment Outcomes
A study testing Intensive anti-smoking counseling in people with Smoking Cessation and Tuberculosis, run by Johns Hopkins University at 1 site in Pakistan.
Trial summary
The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Smoking Cessation, Tuberculosis
- What is being tested?
- Intensive anti-smoking counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, ≥18 years of age
- diagnosed with pulmonary TB
- self-reported current smokers, or smoker within 6 months
- anticipated to be attending the TB treatment clinic for at least 6 months
- be willing to set a quit date within 2 weeks after baseline assessment
- agree to participate
Who cannot join
- less than 18 years of age
- quit for more than 6 months
- extra-pulmonary TB
- unable/unwilling to provide written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes
The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.
- Conditions
- Smoking Cessation, Tuberculosis
- Being tested
- Intensive anti-smoking counseling
- Medical subject headings
- Smoking Cessation, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive anti-smoking counselingOther
Study participants randomized to the intervention arm will receive intensive cessation support outside of the TB clinic setting, from a health worker trained in cessation counseling, during the course of their TB treatment. Behavioral elements will consist of follow up using unscheduled drop in or phone sessions, motivational interviewing, and counseling tailored to the needs and circumstances of the patient. Patients who are current smokers and are ready to commit to quit smoking will be supported to stop completely. Recent smokers will supported for having quit, and the counselor will discuss coping strategies to maintain abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Intensive anti-smoking counseling Receives: Other: Intensive anti-smoking counseling |
| Standard Care | No intervention | Control group will receive current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate
Measured: 1-6 months
Smoking cessation rate
Measured: 6 months post-TB treatment
Secondary outcomes (1)
negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy
To assess differences in TB treatment outcomes between smokers and quitters, all patients enrolled in the intervention trial will be included in analyses of a composite negative outcome variable, defined as a composite endpoint of poor clinical response to TB treatment including death, treatment failure, relapse, and/or requirement for prolongation of TB therapy. Risk of a negative treatment outcome will be compared between the following 3 groups: 1) TB patients who were current smokers and quit smoking for 6 months of follow-up; 2) TB patients who were recent smokers and stayed quit for 6 months of follow-up; and, 3) TB patients who are never smokers.
Measured: 6 months post-TB treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start25 May 2015
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Fund, National Tuberculosis Control Program, Pakistan
- Responsible party
- Sponsor
- Investigators
- Jonathan E Golub, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238405
- Sponsor's protocol ID
- IRB00037636
- Status last verified
- Aug 2018
- First submitted
- 22 Jul 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Smoking Cessation Trial and Prospective Cohort Study of TB Treatment Outcomes
- ClinicalTrials.gov ID
- NCT02238405
- Acronym / sponsor ID
- IRB00037636
- Conditions
- Smoking Cessation, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Global Fund, National Tuberculosis Control Program, Pakistan
- Study start
- 25 May 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary focus of this intervention trial is to understand the effect of quitting smoking on TB treatment outcomes. The investigators will compare a cessation strategy based on guidelines recommended by the World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUTLD). This is currently not utilized in TB directly observed therapy (DOT) clinics in Pakistan. The investigators study will provide comprehensive data towards understanding the effectiveness of these strategies for TB patients who smoke in Pakistan, and most importantly, on the effect of quitting smoking on TB treatment outcomes. These findings will guide development of effective smoking cessation strategies in a region with high prevalence of TB and increasing tobacco use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Other: Intensive anti-smoking counselingIntensive anti-smoking counseling |
| Standard Care | No intervention | –Control group will receive current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males, ≥18 years of age
- diagnosed with pulmonary TB
- self-reported current smokers, or smoker within 6 months
- anticipated to be attending the TB treatment clinic for at least 6 months
- be willing to set a quit date within 2 weeks after baseline assessment
Key exclusion criteria (4 listed)
- less than 18 years of age
- quit for more than 6 months
- extra-pulmonary TB
- unable/unwilling to provide written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive anti-smoking counselingStudy participants randomized to the intervention arm will receive intensive cessation support outside of the TB clinic setting, from a health worker trained in cessation counseling, during the course of their TB treatment. Behavioral elements will consist of follow up using unscheduled drop in or phone sessions, motivational interviewing, and counseling tailored to the needs and circumstances of the patient. Patients who are current smokers and are ready to commit to quit smoking will be supported to stop completely. Recent smokers will supported for having quit, and the counselor will discuss coping strategies to maintain abstinence. | Other | Counseling |
Primary outcome
Smoking cessation rate
Time frame: 1-6 months
Smoking cessation rate
Time frame: 6 months post-TB treatment
1 secondary outcome
negative TB treatment outcome (death, treatment failure, relapse, required prolongation of TB therapy
Time frame: 6 months post-TB treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan E Golub, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive anti-smoking counseling in people with Smoking Cessation and Tuberculosis, run by Johns Hopkins University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rate (time frame: 1-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.