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Cessation of Smoking Trial in the Emergency Department

Cessation of Smoking Trial in the Emergency Department

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04854616
Acronym
COSTED
Enrollment
972
Registered
2021-04-22
Start date
2022-01-04
Completion date
2023-09-30
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-Cig Use, Electronic Cigarette Use, Smoking Cessation, Vaping

Keywords

intervention, emergency department, e-cigarette, electronic cigarette, A&E, Accident and Emergency, vaping, behavioural intervention, stop smoking services

Brief 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). 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. 1. To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems 2. 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 3. To undertake a cost effectiveness analysis of the intervention in comparison with usual care, from an NHS and personal social services (PSS) perspective 4. 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.

Interventions

BEHAVIORALCoSTED Intervention

Brief smoking cessation advice, the provision of an e-cigarette starter kit and training in its use, and referral to stop smoking services.

Sponsors

Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead SponsorOTHER
University of East Anglia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. Adults ≥18 years old who are current daily tobacco smokers 2. Current daily tobacco smoker (self-reporting smoking of at least one cigarette per day) 3. Attending the ED for medical treatment (or accompanying a patient attending for medical treatment) 4. Submitting an expired carbon monoxide (CO) breath test reading of more than ≥8 parts per million (ppm).

Exclusion criteria

1. Requiring immediate medical treatment as defined by the treating clinician. 2. In police custody. 3. Known history of allergy to nicotine replacement products. 4. Currently defined as dual users - already using an e-cigarette daily as well as smoking conventional cigarettes. 5. Without the capacity to give informed consent for participation in the study 6. Have taken part in the CoSTED trial already

Design outcomes

Primary

MeasureTime frameDescription
Continuous Smoking Abstinence6 months after randomisationThe 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)

Secondary

MeasureTime frameDescription
7-day Point Prevalence Abstinence6 months after randomisation7-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
Number of Quit Attempts6 months after randomisationNumerical value
Number of Cigarettes Per Day6 months after randomisationNumerical value
Nicotine Dependence6 months after randomisationMeasured 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.
Number of Times Using an E-cigarette Per Day6 months after randomisationNumerical value
Self-reported Dry Cough or Mouth or Throat Irritation6 months after randomisationThis 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)
Motivation to Stop Smoking6 months after randomisationMotivation to Stop Smoking scale 1-7. 1= no motivation to stop smoking (worst score) 7= motivate to stop in the next month (best score)
Adverse Events6 months after randomisationThe number of participants reporting serious adverse events.
Smoking Status1 month after randomisationThis will be a binary question of "have you smoked even a single puff of a cigarette in the past 2 weeks"- point prevalence abstinence
Smoking Status at 3 Months3 months after randomisationThis 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
Smoking Status at 6 Months6 months after randomisationThis 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

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORIan Pope, MD

Norfolk and Norwich University Hospitals NHS Foundation Trust

Baseline characteristics

Characteristic
Age, Continuous40.50 years
STANDARD_DEVIATION 13.65
Carbon monoxide concentration488 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
64 Participants
Race (NIH/OMB)
Black or African American
57 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
26 Participants
Race (NIH/OMB)
White
825 Participants
Sex: Female, Male
Female
187 Participants
Sex: Female, Male
Male
301 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3100 / 292
other
Total, other adverse events
23 / 31020 / 292
serious
Total, serious adverse events
25 / 31025 / 292

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026