N/A
N=972
Cessation of Smoking Trial in the Emergency Department
Smoking Cessation · Electronic Cigarette Use · E-Cig Use · Vaping
Bottom Line
View on ClinicalTrials.gov: NCT04854616 ↗Enrolled (actual)
972
Serious AEs
8.3%
Results posted
Apr 2026
Primary outcome: Primary: Continuous Smoking Abstinence — 35; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CoSTED Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Smoking Abstinence |
35; 20 | — |
| SECONDARY 7-day Point Prevalence Abstinence |
113; 63 | — |
| SECONDARY Number of Quit Attempts |
2; 1 | — |
| SECONDARY Number of Cigarettes Per Day |
0; 10 | — |
| SECONDARY Nicotine Dependence |
3.7; 4.17 | — |
| SECONDARY Number of Times Using an E-cigarette Per Day |
5; 0 | — |
| SECONDARY Self-reported Dry Cough or Mouth or Throat Irritation |
1; 1; 1; 1 | — |
| SECONDARY Motivation to Stop Smoking |
4; 4 | — |
| SECONDARY Adverse Events |
25; 25 | — |
| SECONDARY Smoking Status |
94; 49 | — |
| SECONDARY Smoking Status at 3 Months |
113; 58 | — |
| SECONDARY Smoking Status at 6 Months |
113; 63 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04854616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.