Smoking CessationNCT02195739
Nicotine Replacement Therapy and Cardiovascular Disease
An observational study of Smoking Cessation, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare the cardiovascular disease event rate in smokers undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with the event rate in smokers attempting smoking cessation assisted by pharmacological interventions - by nicotine replacement therapy (as any… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- How many people
- 61,050 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt was assisted by one of the following pharmacological interventions: (i) nicotine replacement therapy as any, or a combination, of transdermal patches, nasal spray, gum and tablets, inhaler. (ii) Other (e.g. bupropion, varenicline). NON-EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt involved receipt of smoking cessation advice that resulted in a quit attempt unaided by pharmacological therapies.
Who may be able to join
- The analysis will include an exposure group comprising smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose first recorded smoking cessation intervention was a cessation attempt assisted by either nicotine replacement therapy (using any of, or a combination of products) or another pharmacological smoking cessation intervention (e.g. bupropion, varenicline) at the index date.
- Patients must also meet the following inclusion criteria:
- Aged: 18-75 years.
- Have at least one year of up-to-standard baseline data as defined by Clinical Practice Research Datalink (prior to the index smoking cessation attempt) and at least one year of up-to-standard outcome data (following the index smoking cessation attempt) or up-to-standard data up to the time of death if death occurred within the outcome period.
Who cannot join
- Patients will be excluded from the analysis if they:
- Have had exposure to any nicotine replacement therapy or other pharmacological smoking cessation interventions in the baseline period (year prior to the index smoking cessation attempt), and/or
- Switched between types of smoking cessation interventions (i.e. nicotine replacement therapy to other pharmacological smoking cessation interventions or vice versa) during the outcome period(s). Switching between different nicotine replacement therapy products, or use of multiple nicotine replacement therapy products, will be permissible and analysis may involve a comparison of outcomes relative to nicotine exposure over the various outcome periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Real-life Evaluation of the Cardiovascular Disease Risk Associated With Exposure to Pharmacological Smoking Cessation Interventions in a Representative UK Primary Care Patient Population.
The aim of this study is to compare the cardiovascular disease event rate in smokers undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with the event rate in smokers attempting smoking cessation assisted by pharmacological interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray, transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary care population.
Read the detailed description
Preliminary study data have indicated a possible increased cardiovascular disease risk in patients exposed to nicotine replacement therapy compared with controls (i.e. non-nicotine replacement therapy exposed patients) of a magnitude that could not reasonably be accounted for by differences in the cardiovascular risk profile of the two patient groups. Further in-depth studies in this area are warranted.
This retrospective study will compare the cardiovascular disease event risk in a group of smokers undertaking pharmacologically unaided smoking cessation attempts with the event rate in a group of smokers attempting smoking cessation assisted by pharmacological interventions (any of nicotine replacement therapy, bupropion or varenicline) in a representative UK primary care population.
There are three main types of pharmacological interventions currently available for smoking cessation, each of which has demonstrated efficacy when used in conjunction with behavioural support: nicotine replacement therapy, bupropion, and varenicline. Other medications, especially nortryptiline and clonidine, are considered to be effective adjunct therapy in smoking cessation, but they remain second-line options at this time.
Nicotine replacement therapy has been available since the 1980s and bupropion since 2000. Either approach to cessation doubles the chance of achieving abstinence when compared with unsupported quit attempts. After being granted its European licence in 2006, varenicline joined the pharmacological smoking cessation armamentarium. It is the first drug developed specifically for the treatment of tobacco dependence that contains no nicotine, and it triples smokers' chances of quitting compared with unsupported quit attempts.
As the fore-runner, nicotine replacement therapy is the longest-standing of the existing pharmacological smoking cessation interventions currently available. It aims to alleviate nicotine withdrawal symptoms by substituting the nicotine attained through tobacco smoking via alternative means (e.g. nasal sprays, inhalers, gum and tablets, transdermal patches). The various nicotine replacement therapy products available have differing durations of action and allow patients to tailor their nicotine intake according to their particular needs.For example, patches can be used to substitute for background nicotine and gums or tablets can be used to help satisfy urges.
- Conditions
- Smoking Cessation
- Keywords
- smoking, smoking cessation, cardiovascular disease, pharmacological intervention, UK primary care population, nicotine replacement therapy
- Medical subject headings
- Smoking Cessation, Smoking, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine replacement therapy cohort | Cohort defined as patients in whom nicotine replacement therapy (in any preparation) was initiated at the index smoking cessation attempt as the first recorded smoking cessation intervention. | |
| Other smoking cessation therapy | Cohort defined as patients in whom other (non-nicotine replacement therapy) smoking cessation pharmacotherapy's were initiated at the index smoking cessation attempt (e.g. bupropion, varenicline) as the first recorded smoking cessation intervention | |
| Smoking cessation advice cohort | Cohort (control patients) defined as patients whose first recorded smoking cessation intervention involved smoking cessation advice leading to a quit attempt unassisted by pharmacological smoking cessation aids, at the index smoking cessation attempt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first coronary heart disease diagnosis
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior coronary heart disease.
Measured: 4 weeks
Time to first cerebrovascular disease diagnosis.
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior cerebrovascular disease.
Measured: 4 weeks
Secondary outcomes (6)
Time to first coronary heart disease diagnosis
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior coronary heart disease.
Measured: 52 weeks
Time to first cerebrovascular disease diagnosis
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior cerebrovascular disease.
Measured: 52 weeks
Odds of recording one or more consultations for coronary heart disease or cerebrovascular disease
Analysed using conditional logistic regression model. Recorded General Practice consultations or hospital attendances for coronary heart disease or cerebrovascular disease, including General Practice consultations, Accident \& Emergency attendance, out-patient department attendance or in-patient admissions.
Measured: 52 weeks
Survival time for coronary heart disease-related death.
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt.
Measured: 52 weeks
Survival time for cerebrovascular disease-related death.
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt.
Measured: 52 weeks
Survival time for all-cause mortality.
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- David Price, Prof, MD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195739
- Sponsor's protocol ID
- E02311
- Status last verified
- Sep 2014
- First submitted
- 14 May 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fiore MC, Bailey WC, Cohen SJ, et al. Treating tobacco use and dependence. Clinical practice guideline. Rockville (MD): US Department of Health and Human Services, Public Health Service, 2000
West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Health Education Authority. Thorax. 2000 Dec;55(12):987-99. doi: 10.1136/thorax.55.12.987.
PubMed 11083883Le Foll B, George TP. Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. 2007 Nov 20;177(11):1373-80. doi: 10.1503/cmaj.070627.
PubMed 18025429Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
PubMed 18253970Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD006103. doi: 10.1002/14651858.CD006103.pub2.
PubMed 17253581British Medical Association and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Version 56. London; BNF Group; 2008.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Real-life Evaluation of the Cardiovascular Disease Risk Associated With Exposure to Pharmacological Smoking Cessation Interventions in a Representative UK Primary Care Patient Population.
- ClinicalTrials.gov ID
- NCT02195739
- Acronym / sponsor ID
- E02311
- Conditions
- Smoking Cessation
- Keywords
- smoking, smoking cessation, cardiovascular disease, pharmacological intervention, UK primary care population, nicotine replacement therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 61,050 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Jul 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 aim of this study is to compare the cardiovascular disease event rate in smokers undertaking pharmacologically unaided smoking cessation attempts (the non-exposed group) with the event rate in smokers attempting smoking cessation assisted by pharmacological interventions - by nicotine replacement therapy (as any, or a combination, of: nasal spray, transdermal patches, inhaler or gum and tablets) or other pharmacological smoking cessation aids (e.g. bupropion [Zyban®] and varenicline [Champix®]) - in a representative UK primary care population.
Detailed description
Preliminary study data have indicated a possible increased cardiovascular disease risk in patients exposed to nicotine replacement therapy compared with controls (i.e. non-nicotine replacement therapy exposed patients) of a magnitude that could not reasonably be accounted for by differences in the cardiovascular risk profile of the two patient groups. Further in-depth studies in this area are warranted.
This retrospective study will compare the cardiovascular disease event risk in a group of smokers undertaking pharmacologically unaided smoking cessation attempts with the event rate in a group of smokers attempting smoking cessation assisted by pharmacological interventions (any of nicotine replacement therapy, bupropion or varenicline) in a representative UK primary care population.
There are three main types of pharmacological interventions currently available for smoking cessation, each of which has demonstrated efficacy when used in conjunction with behavioural support: nicotine replacement therapy, bupropion, and varenicline. Other medications, especially nortryptiline and clonidine, are considered to be effective adjunct therapy in smoking cessation, but they remain second-line options at this time.
Nicotine replacement therapy has been available since the 1980s and bupropion since 2000. Either approach to cessation doubles the chance of achieving abstinence when compared with unsupported quit attempts. After being granted its European licence in 2006, varenicline joined the pharmacological smoking cessation armamentarium. It is the first drug developed specifically for the treatment of tobacco dependence that contains no nicotine, and it triples smokers' chances of quitting compared with unsupported quit attempts.
As the fore-runner, nicotine replacement therapy is the longest-standing of the existing pharmacological smoking cessation interventions currently available. It aims to alleviate nicotine withdrawal symptoms by substituting the nicotine attained through tobacco smoking via alternative means (e.g. nasal sprays, inhalers, gum and tablets, transdermal patches). The various nicotine replacement therapy products available have differing durations of action and allow patients to tailor their nicotine intake according to their particular needs.For example, patches can be used to substitute for background nicotine and gums or tablets can be used to help satisfy urges.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine replacement therapy cohort | – | –Cohort defined as patients in whom nicotine replacement therapy (in any preparation) was initiated at the index smoking cessation attempt as the first recorded smoking cessation intervention. |
| Other smoking cessation therapy | – | –Cohort defined as patients in whom other (non-nicotine replacement therapy) smoking cessation pharmacotherapy's were initiated at the index smoking cessation attempt (e.g. bupropion, varenicline) as the first recorded smoking cessation intervention |
| Smoking cessation advice cohort | – | –Cohort (control patients) defined as patients whose first recorded smoking cessation intervention involved smoking cessation advice leading to a quit attempt unassisted by pharmacological smoking cessation aids, at the index smoking cessation attempt. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt was assisted by one of the following pharmacological interventions: (i) nicotine replacement therapy as any, or a combination, of transdermal patches, nasal spray, gum and tablets, inhaler. (ii) Other (e.g. bupropion, varenicline). NON-EXPOSED PATIENTS: include smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose index smoking cessation attempt involved receipt of smoking cessation advice that resulted in a quit attempt unaided by pharmacological therapies.
Key inclusion criteria (4 listed)
- The analysis will include an exposure group comprising smokers with no recorded smoking cessation attempts using pharmacological aids in the prior year, whose first recorded smoking cessation intervention was a cessation attempt assisted by either nicotine replacement therapy (using any of, or a combination of products) or another pharmacological smoking cessation intervention (e.g. bupropion, varenicline) at the index date.
- Aged: 18-75 years.
- Have at least one year of up-to-standard baseline data as defined by Clinical Practice Research Datalink (prior to the index smoking cessation attempt) and at least one year of up-to-standard outcome data (following the index smoking cessation attempt) or up-to-standard data up to the time of death if death occurred within the outcome period.
Key exclusion criteria (3 listed)
- Have had exposure to any nicotine replacement therapy or other pharmacological smoking cessation interventions in the baseline period (year prior to the index smoking cessation attempt), and/or
- Switched between types of smoking cessation interventions (i.e. nicotine replacement therapy to other pharmacological smoking cessation interventions or vice versa) during the outcome period(s). Switching between different nicotine replacement therapy products, or use of multiple nicotine replacement therapy products, will be permissible and analysis may involve a comparison of outcomes relative to nicotine exposure over the various outcome periods.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first coronary heart disease diagnosis
Time frame: 4 weeks
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior coronary heart disease.
Time to first cerebrovascular disease diagnosis.
Time frame: 4 weeks
Analysed using Cox's proportional hazards model. Time from index smoking cessation attempt. Excluding patients with prior cerebrovascular disease.
6 secondary outcomes
Time to first coronary heart disease diagnosis
Time frame: 52 weeks
Time to first cerebrovascular disease diagnosis
Time frame: 52 weeks
Odds of recording one or more consultations for coronary heart disease or cerebrovascular disease
Time frame: 52 weeks
Survival time for coronary heart disease-related death.
Time frame: 52 weeks
Survival time for cerebrovascular disease-related death.
Time frame: 52 weeks
Survival time for all-cause mortality.
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- BackgroundFiore MC, Bailey WC, Cohen SJ, et al. Treating tobacco use and dependence. Clinical practice guideline. Rockville (MD): US Department of Health and Human Services, Public Health Service, 2000
- Background: PubMed 11083883West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Health Education Authority. Thorax. 2000 Dec;55(12):987-99. doi: 10.1136/thorax.55.12.987.
- Background: PubMed 18025429Le Foll B, George TP. Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. 2007 Nov 20;177(11):1373-80. doi: 10.1503/cmaj.070627.
- Background: PubMed 18253970Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
- Background: PubMed 17253581Cahill K, Stead LF, Lancaster T. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD006103. doi: 10.1002/14651858.CD006103.pub2.
- BackgroundBritish Medical Association and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Version 56. London; BNF Group; 2008.
- World Health Organization (WHO). 2007. The European tobacco control report 2007 \[online\]Link provided by the sponsor.
- eto R, Lopez AD, Boreham J, et al. 2006. Mortality from smoking in developed countries 1950 - 2000 (2nd ed.) \[online\]Link provided by the sponsor.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
David Price, Prof, MD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Research in Real-Life Ltd at 1 site in United Kingdom.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Oct 2014. 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 Kingdom. 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?
Results are not available in the source record.
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?
Time to first coronary heart disease diagnosis (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT02195739, which also lists 6 linked publications.
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 1 Oct 2014.