Cessation of Smoking Trial in the Emergency Department (NCT04854616) | Clinical Trial Compass
CompletedNot Applicable
Cessation of Smoking Trial in the Emergency Department
United Kingdom972 participantsStarted 2022-01-04
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕
What they're measuring
1
Continuous Smoking Abstinence
Timeframe: 6 months after randomisation
Trial details
NCT IDNCT04854616
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust