Smoking CessationCOSTEDNCT04854616
Cessation of Smoking Trial in the Emergency Department
A study testing CoSTED Intervention in people with Smoking Cessation and Electronic Cigarette Use, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Electronic Cigarette Use, E-Cig Use
- What is being tested?
- CoSTED Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 972 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2022to 30 Sep 2023
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old who are current daily tobacco smokers
- Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day)
- Attending the ED for medical treatment (or accompanying a patient attending for medical treatment)
- Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm).
Who cannot join
- Requiring immediate medical treatment as defined by the treating clinician.
- In police custody.
- Known history of allergy to nicotine replacement products.
- Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes.
- Without the capacity to give informed consent for participation in the study
- Have taken part in the CoSTED trial already
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
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.
Read the detailed description
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.
- To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems
- To definitively test real-world effectiveness of an ED based smoking cessation intervention in comparison with usual care, by comparing smoking abstinence at 6 month follow-up between trial groups
- To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective
- To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination
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.
- Conditions
- Smoking Cessation, Electronic Cigarette Use, E-Cig Use, Vaping
- Being tested
- CoSTED Intervention
- Keywords
- intervention, emergency department, e-cigarette, electronic cigarette, A&E, Accident and Emergency, vaping, behavioural intervention, stop smoking services
- Medical subject headings
- Smoking Cessation, Vaping, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoSTED InterventionBehavioural
Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.
| Study group | Role | What they receive |
|---|---|---|
| CoSTED Intervention | Experimental | 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 Receives: Behavioral: CoSTED Intervention |
| Treatment as Usual | No intervention | Signposting to NHS smoking cessation services through provision of written information about local services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months after randomisation
Secondary outcomes (11)
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
Measured: 6 months after randomisation
Number of Quit Attempts
Numerical value
Measured: 6 months after randomisation
Number of Cigarettes Per Day
Numerical value
Measured: 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.
Measured: 6 months after randomisation
Number of Times Using an E-cigarette Per Day
Numerical value
Measured: 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)
Measured: 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)
Measured: 6 months after randomisation
Adverse Events
The number of participants reporting serious adverse events.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start4 Jan 2022
- Primary completion31 Mar 2023
- Study completion30 Sep 2023
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 (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 972 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Ian Pope, MD, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854616
- Sponsor's protocol ID
- R208399
- Other IDs
- NIHR129438
- Acronym
- COSTED
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2021
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Notley C, Clark L, Belderson P, Ward E, Clark AB, Parrott S, Agrawal S, Bloom BM, Boyle AA, Morris G, Gray A, Coats T, Man MS, Bauld L, Holland R, Pope I. Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Jan 18;13(1):e064585. doi: 10.1136/bmjopen-2022-064585.
PubMed 36657751Ward E, Belderson P, Clark A, Stirling S, Clark L, Pope I, Notley C. How do people quit smoking using e-cigarettes? A mixed-methods exploration of participant smoking pathways following receiving an opportunistic e-cigarette-based smoking cessation intervention. Addiction. 2024 Dec;119(12):2185-2196. doi: 10.1111/add.16633. Epub 2024 Sep 10.
PubMed 39252616Pope I, Clark LV, Clark A, Ward E, Belderson P, Stirling S, Parrott S, Li J, Coats T, Bauld L, Holland R, Gentry S, Agrawal S, Bloom BM, Boyle AA, Gray AJ, Morris MG, Livingstone-Banks J, Notley C. Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial. Emerg Med J. 2024 Apr 22;41(5):276-282. doi: 10.1136/emermed-2023-213824.
PubMed 38531658Belderson P, Ward E, Pope I, Notley C. Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial. BMJ Open. 2024 Mar 4;14(3):e078677. doi: 10.1136/bmjopen-2023-078677.
PubMed 38443079
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cessation of Smoking Trial in the Emergency Department
- ClinicalTrials.gov ID
- NCT04854616
- Acronym / sponsor ID
- COSTED / R208399
- Conditions
- Smoking Cessation, Electronic Cigarette Use, E-Cig Use, Vaping
- Keywords
- intervention, emergency department, e-cigarette, electronic cigarette, A&E, Accident and Emergency, vaping, behavioural intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 972 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems
- To definitively test real-world effectiveness of an ED based smoking cessation intervention in comparison with usual care, by comparing smoking abstinence at 6 month follow-up between trial groups
- To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective
- To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoSTED Intervention | Experimental | Behavioral: CoSTED InterventionCoSTED 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 |
| Treatment as Usual | No intervention | –Signposting to NHS smoking cessation services through provision of written information about local services. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years old who are current daily tobacco smokers
- Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day)
- Attending the ED for medical treatment (or accompanying a patient attending for medical treatment)
- Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm).
Key exclusion criteria (6 listed)
- Requiring immediate medical treatment as defined by the treating clinician.
- In police custody.
- Known history of allergy to nicotine replacement products.
- Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes.
- Without the capacity to give informed consent for participation in the study
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 |
|---|---|---|
| CoSTED InterventionBrief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services. | Behavioural | CoSTED Intervention |
Primary outcome
Continuous Smoking Abstinence
Time frame: 6 months after randomisation
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)
11 secondary outcomes
7-day Point Prevalence Abstinence
Time frame: 6 months after randomisation
Number of Quit Attempts
Time frame: 6 months after randomisation
Number of Cigarettes Per Day
Time frame: 6 months after randomisation
Nicotine Dependence
Time frame: 6 months after randomisation
Number of Times Using an E-cigarette Per Day
Time frame: 6 months after randomisation
Self-reported Dry Cough or Mouth or Throat Irritation
Time frame: 6 months after randomisation
Motivation to Stop Smoking
Time frame: 6 months after randomisation
Adverse Events
Time frame: 6 months after randomisation
Smoking Status
Time frame: 1 month after randomisation
Smoking Status at 3 Months
Time frame: 3 months after randomisation
Smoking Status at 6 Months
Time frame: 6 months after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36657751Notley C, Clark L, Belderson P, Ward E, Clark AB, Parrott S, Agrawal S, Bloom BM, Boyle AA, Morris G, Gray A, Coats T, Man MS, Bauld L, Holland R, Pope I. Cessation of smoking trial in the emergency department (CoSTED): protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Jan 18;13(1):e064585. doi: 10.1136/bmjopen-2022-064585.
- Derived from this study: PubMed 39252616Ward E, Belderson P, Clark A, Stirling S, Clark L, Pope I, Notley C. How do people quit smoking using e-cigarettes? A mixed-methods exploration of participant smoking pathways following receiving an opportunistic e-cigarette-based smoking cessation intervention. Addiction. 2024 Dec;119(12):2185-2196. doi: 10.1111/add.16633. Epub 2024 Sep 10.
- Derived from this study: PubMed 38531658Pope I, Clark LV, Clark A, Ward E, Belderson P, Stirling S, Parrott S, Li J, Coats T, Bauld L, Holland R, Gentry S, Agrawal S, Bloom BM, Boyle AA, Gray AJ, Morris MG, Livingstone-Banks J, Notley C. Cessation of Smoking Trial in the Emergency Department (COSTED): a multicentre randomised controlled trial. Emerg Med J. 2024 Apr 22;41(5):276-282. doi: 10.1136/emermed-2023-213824.
- Derived from this study: PubMed 38443079Belderson P, Ward E, Pope I, Notley C. Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial. BMJ Open. 2024 Mar 4;14(3):e078677. doi: 10.1136/bmjopen-2023-078677.
- CoSTED trial web pageLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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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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.
Ian Pope, MD principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoSTED Intervention in people with Smoking Cessation and Electronic Cigarette Use, run by Norfolk and Norwich University Hospitals NHS Foundation Trust 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 6 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 30 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). 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?
Continuous Smoking Abstinence (time frame: 6 months after randomisation). 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 NCT04854616, which also lists 4 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 30 Apr 2026.