An interventional study of CoSTED Intervention in Smoking Cessation, Electronic Cigarette Use and E-Cig Use, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
The Cessation of Smoking Trial in the Emergency Department (CoSTED) is an National Institute for Health Research (NIHR) Health Technology Assessment (HTA) funded randomised controlled trial (RCT). The research question is "in people attending the Emergency Department who smoke, does a brief intervention (including the provision of an electronic cigarette (e-cigarette) and referral to stop smoking services) increase smoking cessation in comparison with usual care and is it cost effective?" The trial includes an internal pilot, health economic evaluation and process evaluation. The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm. The sample size is 972 (486 in intervention and control) across 6 sites.
Research question:
In people attending the Emergency Department who smoke, does a brief intervention (including the provision of an e-cigarette and referral to stop smoking services) increase smoking cessation in comparison with usual care and is it cost effective?
Background:
Tobacco smoking is the leading cause of years of life lost in the United Kingdom (UK), and negatively impacts significantly on physical health conditions and recovery outcomes from injury or surgery. Currently, smoking prevalence is recorded at approximately 15% of the population, but this masks substantial variation between different population groups. Patient and Public Involvement (PPI) development work demonstrates that prevalence of smoking for people attending the emergency department is approximately 24%. Most current smokers will, if asked, state that they want to quit, but need support. The National Health Service (NHS) long term plan and the Tobacco control plan for England recommend smokers are supported to quit at every contact with the health service by 2023/4. To date there have been no RCTs of smoking cessation support in the Emergency Department (ED) setting in the UK, which potentially provides a highly motivating opportunistic route to intervention.
Aims and objectives:
To undertake an RCT, with internal pilot, comparing a brief intervention (including provision of an e-cigarette and referral to local smoking cessation services), assessing long term smoking abstinence, in people attending Emergency Departments.
Methods:
Randomised Controlled Trial of people who smoke attending an Emergency Department, with an internal pilot, health economic evaluation and process evaluation. The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm. The sample size is 972 (with a power of 90% and a difference in quit rates between the groups of 6%).
Anticipated impact and dissemination:
The investigators will definitively test an ED based smoking cessation intervention and make recommendations for future implementation if effective. The intervention has the potential to reduce smoking prevalence by at least 6% based on existing evidence, impacting on improved long term health outcomes for approximately 334,000 members of the UK population if adopted across the NHS. Results will be disseminated at international conferences and published in leading journals to reach academic experts, through NHS networks and the Royal College of Emergency Medicine to reach commissioners, managers and members of the public.
304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.
This study's enrollment of 972 is above the median of 154 across 285 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Norfolk and Norwich University Hospitals NHS Foundation Trust is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CoSTED is an opportunistic smoking cessation intervention comprising three elements: 1. brief smoking cessation advice 2. the provision of an electronic cigarette (e-cigarette) and training in its use 3. referral to stop-smoking services
Behavioral: CoSTED Intervention
Signposting to NHS smoking cessation services through provision of written information about local services.
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
Continuous Smoking Abstinence
The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm.This is according to the Russell standard, stated as: continuous abstinence (Russell Standard) \[ Time Frame: Six months post quit date \] Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide)
Time frame: 6 months after randomisation
7-day Point Prevalence Abstinence
7-day point prevalence abstinence, i.e. current smoking status, Self-report of having smoked no cigarettes (not even a puff) in the past seven days, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm
Time frame: 6 months after randomisation
Number of Quit Attempts
Numerical value
Time frame: 6 months after randomisation
Number of Cigarettes Per Day
Numerical value
Time frame: 6 months after randomisation
Nicotine Dependence
Measured by using the Fagerstrom test for nicotine dependence. 1-2= low dependence, 3-4 low to moderate dependence, 5-7= moderate dependence, 8-10= high dependence. Minimum score is 1 and maximum score is 10.
Time frame: 6 months after randomisation
Number of Times Using an E-cigarette Per Day
Numerical value
Time frame: 6 months after randomisation
Self-reported Dry Cough or Mouth or Throat Irritation
This will be measures on symptoms in the last week on a scale of 1-5, 1= not at all (best score) to 5= extremely (worst score)
Time frame: 6 months after randomisation
Motivation to Stop Smoking
Motivation to Stop Smoking scale 1-7. 1= no motivation to stop smoking (worst score) 7= motivate to stop in the next month (best score)
Time frame: 6 months after randomisation
Adverse Events
The number of participants reporting serious adverse events.
Time frame: 6 months after randomisation
Smoking Status
This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
Time frame: 1 month after randomisation
Smoking Status at 3 Months
This is the only outcome that will be asked at 1-month, 3-months and 6-months from randomisation. This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
Time frame: 3 months after randomisation
Smoking Status at 6 Months
This is the only outcome that will be asked at 1-month, 3-months and 6-months from randomisation. This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
Time frame: 6 months after randomisation
| Milestone | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Started | 484 | 488 |
| Completed | 479 | 476 |
| Not completed | 5 | 12 |
| Withdrew: Withdrawal by subject | 5 | 12 |
The primary outcome is smoking cessation, self-reported as continuous smoking abstinence, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm.This is according to the Russell standard, stated as: continuous abstinence (Russell Standard) \[ Time Frame: Six months post quit date \] Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide)
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Continuous Smoking Abstinence | 35 | 20 |
7-day point prevalence abstinence, i.e. current smoking status, Self-report of having smoked no cigarettes (not even a puff) in the past seven days, biochemically validated by carbon monoxide monitoring with cut off of ≥8ppm
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| 7-day Point Prevalence Abstinence | 113 | 63 |
Numerical value
| Number of quit attempts | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Number of Quit Attempts | 2 (1 to 4) | 1 (0 to 3) |
Numerical value
| Number of cigarette smoked a day | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Number of Cigarettes Per Day | 0 (0 to 10) | 10 (0 to 15) |
Measured by using the Fagerstrom test for nicotine dependence. 1-2= low dependence, 3-4 low to moderate dependence, 5-7= moderate dependence, 8-10= high dependence. Minimum score is 1 and maximum score is 10.
| score on scale | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Nicotine Dependence | 3.7 ± 2.21 | 4.17 ± 2.24 |
Numerical value
| Number of E-Cigarettes per day | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Number of Times Using an E-cigarette Per Day | 5 (0 to 10) | 0 (0 to 3) |
This will be measures on symptoms in the last week on a scale of 1-5, 1= not at all (best score) to 5= extremely (worst score)
| scores on a scale | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Score 1-5 (dry cough)1= not at all (best score) to 5= extremely (worst score) | 1 (1 to 2) | 1 (1 to 3) |
| Score 1-5 (Throat/ Mouth irritation)1= not at all (best score) to 5= extremely (worst score) | 1 (1 to 2) | 1 (1 to 2) |
Motivation to Stop Smoking scale 1-7. 1= no motivation to stop smoking (worst score) 7= motivate to stop in the next month (best score)
| scores on a scale | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Motivation to Stop Smoking | 4 (3 to 5) | 4 (2 to 5) |
The number of participants reporting serious adverse events.
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Adverse Events | 25 | 25 |
This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Smoking Status | 94 | 49 |
This is the only outcome that will be asked at 1-month, 3-months and 6-months from randomisation. This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Smoking Status at 3 Months | 113 | 58 |
This is the only outcome that will be asked at 1-month, 3-months and 6-months from randomisation. This will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
| Participants | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Smoking Status at 6 Months | 113 | 63 |
Collected over from enrolment until end of follow-up up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CoSTED Intervention | 0/310 (0%) | 25/310 (8.1%) | 23/310 (7.4%) |
| Treatment as Usual | 0/292 (0%) | 25/292 (8.6%) | 20/292 (6.8%) |
| Event | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Throat/mouth irritation (extreme)Respiratory, thoracic and mediastinal disorders | 25/310 | 25/292 |
| Event | CoSTED Intervention | Treatment as Usual |
|---|---|---|
| Dry cough (extreme)Respiratory, thoracic and mediastinal disorders | 13/310 | 12/292 |
| Throat/mouth irritation (extreme)Respiratory, thoracic and mediastinal disorders | 10/310 | 8/292 |
| Age, Continuous(years) | CoSTED Intervention | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 40.52 ± 13.58 | 40.48 ± 13.72 | 40.50 ± 13.65 |
| Sex: Female, Male(Participants) | CoSTED Intervention | Treatment as Usual | Total |
|---|---|---|---|
| Female | 182 | 187 | 369 |
| Male | 302 | 301 | 603 |
| Race (NIH/OMB)(Participants) | CoSTED Intervention | Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 28 | 36 | 64 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 29 | 28 | 57 |
| White | 419 | 406 | 825 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 18 | 26 |
| Carbon monoxide concentration(Participants) | CoSTED Intervention | Treatment as Usual | Total |
|---|---|---|---|
| Count of participants | 484 | 488 | 972 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data underlying the main trial results will be available in a public, open access repository immediately following publication of the major findings of the study. Details of the repository and a persistent URL will be provided on publication of the main results. Study protocol, statistical analysis plan, informed consent form, and other documents will also be available.
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Norfolk and Norwich University Hospitals NHS Foundation Trust