SmokingPhase 3NCT02148445
Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
A Phase 3 study testing Standard Smoking Cessation, Extended Nicotine Replacement Therapy and Nicotine replacement therapy in people with Smoking and Pulmonary Disease, Chronic Obstructive, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Pulmonary Disease, Chronic Obstructive, Tobacco Use Disorder
- What is being tested?
- Standard Smoking Cessation, Extended Nicotine Replacement Therapy and Nicotine replacement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Physician-diagnosed COPD
- Smoke 5 or more cigarettes/day
- Smoke cigarettes on 25 or more of the last 30 days
- Speak either English or Spanish
- Willing to take nicotine replacement therapy for up to 1 year and participate in study procedures
Who cannot join
- Reside in a facility that does not allow smoking
- Don't have an address and telephone
- Unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past 30 days)
- Pregnant or breastfeeding
- Terminal illness with less than 12 month life expectancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas University Medical Center
Kansas City, Kansas, 66160
About this study
Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the standard approach of asking patients to quit immediately. The investigators believe that GMT with long-term NRT will reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
In this study, 398 smokers with COPD will be randomly assigned to either receive: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). The SC intervention will be based on a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (a nicotine patch plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The GMT intervention will consist of counseling, focused on medication adherence and smoking reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will compare the two treatments based on their effects on smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing function, and smoking-related hospitalizations or death. The investigators will also analyze the data in such a way that will be able to identify which patients are most likely to benefit from treatment. This analysis will allow patients to estimate their chances of success based on their own personal characteristics and which treatment they choose.
The investigators study addresses research priorities identified in recent smoking cessation guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder Advisory Committee. This study reflects the interests expressed by smokers in prior surveys and addresses the limited reach and effectiveness of traditional approaches to smoking cessation. If our GMT approach is effective, our study could change the recommendations provided in clinical practice guidelines and change the way that insurance companies pay for smoking cessation treatment. GMT could provide an alternative for millions of smokers with COPD who are not currently benefiting from traditional approaches to smoking cessation
Read the detailed description
BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting. Long-term nicotine replacement therapy (NRT) might allow them to do this. Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase quit rates. Long-term NRT has not, however, been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to evaluate the relative benefits of a third option: guided maintenance therapy with long-term NRT. We believe that long-term NRT could reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
OBJECTIVES
- Compare the benefits of traditional smoking cessation (SC) versus guided maintenance therapy (GMT) with NRT for smokers with COPD.
- Estimate rates of smoking cessation and other patient-desired outcomes based on patient-specific characteristics and treatment choice (SC or GMT).
METHODS In this study, we will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). Participants in the SC arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Participants in the GMT arm will receive counseling focused on medication adherence and smoking reduction plus 52 weeks of combined NRT. Outcomes will be measured at 3, 6 and 12 months post-randomization and will assess rates of smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, and clinical outcomes including respiratory symptoms, respiratory function, and smoking-related hospitalizations or death. In addition to directly comparing outcomes in the two treatment arms, our novel classification and regression tree analysis will allow us to identify subgroups of patients most likely to benefit from treatment and will allow patients to estimate their projected outcomes given their personal history and their choice of therapy.
PATIENT OUTCOMES (PROJECTED) This study will show how long-term NRT compares to a traditional smoking cessation program in helping smokers quit, reduce cigarette exposure, lower exposure to carcinogens, and reduce risk for death and hospitalizations. If our hypothesis is correct, this program could dramatically alter treatment choices for the millions of smokers in the United States with COPD that have been frustrated in their attempts to quit.
- Being tested
- Standard Smoking Cessation, Extended Nicotine Replacement Therapy, Nicotine replacement therapy
- Keywords
- smoking cessation, tobacco use cessation products, nicotine
- Medical subject headings
- Smoking, Pulmonary Disease, Chronic Obstructive, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Smoking CessationOther
Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
Extended Nicotine Replacement TherapyOther
Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
Nicotine replacement therapyDrug
Also called nicotine patch, nicotine gum, nicotine lozenge
| Study group | Role | What they receive |
|---|---|---|
| Standard Smoking Cessation | Active comparator | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Receives: Other: Standard Smoking Cessation; Drug: Nicotine replacement therapy |
| Extended Nicotine Replacement Therapy | Experimental | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. Receives: Other: Extended Nicotine Replacement Therapy; Drug: Nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence (Point Prevalent)
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10
Measured: Month 12
Secondary outcomes (15)
Sustained Abstinence
6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have "6-month sustained abstinence."
Measured: Month 6 through Month 12
Quit Attempts
Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.
Measured: Month 3, Month 6, Month 12
Average Cigarettes Per Day
Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 "During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"
Measured: Month 3, Month 6, Month 12
Carbon Monoxide Exposure
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.
Measured: Month 3, Month 6, Month 12
Carcinogen Exposure
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.
Measured: Month 3, Month 6, Month 12
Respiratory Function
Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.
Measured: Month 12
Respiratory Symptoms
Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.
Measured: Month 3, Month 6, Month 12
Respiratory-related Hospital Visits
Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12
Measured: Month 3, Month 6, Month 12
Cardiac-related Hospital Visits
Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.
Measured: Month 3, Month 6, Month 12
7-day Abstinence
Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, "Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days?" They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table.
Measured: Month 3, Month 6, Month 12
Cotinine
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.
Measured: Month 3, Month 6, Month 12
Average Cigarettes Per Day (Continued Smokers Only)
Average number of cigarettes per day over one year, among continued smokers. All participants were asked "During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day?" at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking.
Measured: Month 3, Month 6, Month 12
Carbon Monoxide Exposure (Continued Smokers Only)
Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.
Measured: Month 3, Month 6, Month 12
Carcinogen Exposure (Continued Smokers Only)
Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.
Measured: Month 3, Month 6, Month 12
Cotinine (Continued Smokers Only)
Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.
Measured: Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Edward Ellerbeck, MD, MPH, University of Kansas Medical Center
- Investigators
- Edward F Ellerbeck, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148445
- Sponsor's protocol ID
- STUDY00000666
- Other IDs
- CER-1306-02901
- Status last verified
- Sep 2017
- First submitted
- 23 May 2014
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will create a clean, de-identified copy of our dataset. It will be available to other researchers, upon request. We will make data available to users under a data sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be saved as SAS or SPSS files, saved to disk, encrypted, and mailed to users. A copy of our analytic code used to generate our primary outcomes paper(s) will also be available on request. Given that this study does not meet the threshold for data sharing requirements, the costs of data preparation and shipping will be borne by the requester.
Publications
Ellerbeck EF, Nollen N, Hutcheson TD, Phadnis M, Fitzgerald SA, Vacek J, Sharpe MR, Salzman GA, Richter KP. Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181843. doi: 10.1001/jamanetworkopen.2018.1843.
PubMed 30646142
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
- ClinicalTrials.gov ID
- NCT02148445
- Acronym / sponsor ID
- STUDY00000666
- Keywords
- smoking cessation, tobacco use cessation products, nicotine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- May 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term NRT has not been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the standard approach of asking patients to quit immediately. The investigators believe that GMT with long-term NRT will reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
In this study, 398 smokers with COPD will be randomly assigned to either receive: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). The SC intervention will be based on a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (a nicotine patch plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The GMT intervention will consist of counseling, focused on medication adherence and smoking reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will compare the two treatments based on their effects on smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing function, and smoking-related hospitalizations or death. The investigators will also analyze the data in such a way that will be able to identify which patients are most likely to benefit from treatment. This analysis will allow patients to estimate their chances of success based on their own personal characteristics and which treatment they choose.
The investigators study addresses research priorities identified in recent smoking cessation guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder Advisory Committee. This study reflects the interests expressed by smokers in prior surveys and addresses the limited reach and effectiveness of traditional approaches to smoking cessation. If our GMT approach is effective, our study could change the recommendations provided in clinical practice guidelines and change the way that insurance companies pay for smoking cessation treatment. GMT could provide an alternative for millions of smokers with COPD who are not currently benefiting from traditional approaches to smoking cessation
Detailed description
BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting. Long-term nicotine replacement therapy (NRT) might allow them to do this. Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase quit rates. Long-term NRT has not, however, been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to evaluate the relative benefits of a third option: guided maintenance therapy with long-term NRT. We believe that long-term NRT could reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.
OBJECTIVES
- Compare the benefits of traditional smoking cessation (SC) versus guided maintenance therapy (GMT) with NRT for smokers with COPD.
- Estimate rates of smoking cessation and other patient-desired outcomes based on patient-specific characteristics and treatment choice (SC or GMT).
METHODS In this study, we will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). Participants in the SC arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Participants in the GMT arm will receive counseling focused on medication adherence and smoking reduction plus 52 weeks of combined NRT. Outcomes will be measured at 3, 6 and 12 months post-randomization and will assess rates of smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, and clinical outcomes including respiratory symptoms, respiratory function, and smoking-related hospitalizations or death. In addition to directly comparing outcomes in the two treatment arms, our novel classification and regression tree analysis will allow us to identify subgroups of patients most likely to benefit from treatment and will allow patients to estimate their projected outcomes given their personal history and their choice of therapy.
PATIENT OUTCOMES (PROJECTED) This study will show how long-term NRT compares to a traditional smoking cessation program in helping smokers quit, reduce cigarette exposure, lower exposure to carcinogens, and reduce risk for death and hospitalizations. If our hypothesis is correct, this program could dramatically alter treatment choices for the millions of smokers in the United States with COPD that have been frustrated in their attempts to quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Smoking Cessation | Active comparator | Other: Standard Smoking Cessation, Drug: Nicotine replacement therapyParticipants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. |
| Extended Nicotine Replacement Therapy | Experimental | Other: Extended Nicotine Replacement Therapy, Drug: Nicotine replacement therapyParticipants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Physician-diagnosed COPD
- Smoke 5 or more cigarettes/day
- Smoke cigarettes on 25 or more of the last 30 days
- Speak either English or Spanish
Key exclusion criteria (5 listed)
- Reside in a facility that does not allow smoking
- Don't have an address and telephone
- Unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past 30 days)
- Pregnant or breastfeeding
- Terminal illness with less than 12 month life expectancy
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 |
|---|---|---|
| Standard Smoking CessationParticipants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | Other | Standard Smoking Cessation |
| Extended Nicotine Replacement TherapyParticipants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. | Other | Extended Nicotine Replacement Therapy |
| Nicotine replacement therapyAlso: nicotine patch, nicotine gum, nicotine lozenge | Drug | Extended Nicotine Replacement Therapy, Standard Smoking Cessation |
Primary outcome
Smoking Abstinence (Point Prevalent)
Time frame: Month 12
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10
15 secondary outcomes
Sustained Abstinence
Time frame: Month 6 through Month 12
Quit Attempts
Time frame: Month 3, Month 6, Month 12
Average Cigarettes Per Day
Time frame: Month 3, Month 6, Month 12
Carbon Monoxide Exposure
Time frame: Month 3, Month 6, Month 12
Carcinogen Exposure
Time frame: Month 3, Month 6, Month 12
Respiratory Function
Time frame: Month 12
Respiratory Symptoms
Time frame: Month 3, Month 6, Month 12
Respiratory-related Hospital Visits
Time frame: Month 3, Month 6, Month 12
Cardiac-related Hospital Visits
Time frame: Month 3, Month 6, Month 12
7-day Abstinence
Time frame: Month 3, Month 6, Month 12
Cotinine
Time frame: Month 3, Month 6, Month 12
Average Cigarettes Per Day (Continued Smokers Only)
Time frame: Month 3, Month 6, Month 12
Carbon Monoxide Exposure (Continued Smokers Only)
Time frame: Month 3, Month 6, Month 12
Carcinogen Exposure (Continued Smokers Only)
Time frame: Month 3, Month 6, Month 12
Cotinine (Continued Smokers Only)
Time frame: Month 3, Month 6, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30646142Ellerbeck EF, Nollen N, Hutcheson TD, Phadnis M, Fitzgerald SA, Vacek J, Sharpe MR, Salzman GA, Richter KP. Effect of Long-term Nicotine Replacement Therapy vs Standard Smoking Cessation for Smokers With Chronic Lung Disease: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181843. doi: 10.1001/jamanetworkopen.2018.1843.
- Individual participant dataSharing planned: Yes. We will create a clean, de-identified copy of our dataset. It will be available to other researchers, upon request. We will make data available to users under a data sharing agreement that provides for (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be saved as SAS or SPSS files, saved to disk, encrypted, and mailed to users. A copy of our analytic code used to generate our primary outcomes paper(s) will also be available on request. Given that this study does not meet the threshold for data sharing requirements, the costs of data preparation and shipping will be borne by the requester.
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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.
Edward F Ellerbeck, MD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Smoking Cessation, Extended Nicotine Replacement Therapy and Nicotine replacement therapy in people with Smoking and Pulmonary Disease, Chronic Obstructive, run by University of Kansas Medical Center at 1 site in United States.
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 5 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 6 Oct 2017. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Abstinence (Point Prevalent) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148445, which also lists 1 linked publication.
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 6 Oct 2017.