Smoking Cessation Clinical Trial
— CoSTEDOfficial title:
Cessation of Smoking Trial in the Emergency Department
Verified date | December 2023 |
Source | Norfolk and Norwich University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 987 |
Est. completion date | September 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
Norfolk and Norwich University Hospitals NHS Foundation Trust | University of East Anglia |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 6 months after randomisation | |
Secondary | 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 | 6 months after randomisation | |
Secondary | Number of quit attempts | Numerical value | Baseline and 6 months after randomisation | |
Secondary | Time to relapse (if applicable) | (if applicable) | 6 months after randomisation | |
Secondary | Number of cigarettes per day | Numerical value | Baseline and 6 months after randomisation | |
Secondary | Nicotine dependence | At baseline & 6 month follow up, participants will be asked about their nicotine dependence using the Fagerstrom test for nicotine dependence | Baseline and 6 months after randomisation | |
Secondary | Number of times using an e-cigarette per day | Numerical value | Baseline and 6 months after randomisation | |
Secondary | Self-reported dry cough or mouth or throat irritation | This will be measures as a yes/no response for symptoms in the last week | Baseline and 6 months after randomisation | |
Secondary | Motivation to stop smoking | Motivation to Stop Smoking scale (MTSS) | Baseline and 6 months after randomisation | |
Secondary | Self-reported use of healthcare services in the last 3 months | At baseline & 6 month follow up, participants will be asked about their use of GP services in the past 3 months including number of times they have attended face-to-face and telephone appointments | Baseline and 6 months after randomisation | |
Secondary | Self-reported use of smoking cessation services in the last 3 months | At baseline & 6 month follow up, participants will be asked about their use of smoking cessation services in the past 3 months and number of times attended | Baseline and 6 months after randomisation | |
Secondary | Quality of Life questionnaire | At 6-month follow-up, quality of life will be assessed using EQ-5D-5L where a higher value equates to a lower quality of life (i,e. worse outcome) | Baseline and 6 months after randomisation | |
Secondary | Adverse events | 1, 3, and 6 months after randomisation | ||
Secondary | Smoking status | 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 | 1, 3 & 6 months after randomisation | |
Secondary | Frequency of e-cigarette use in the past 6 months | E-cigarette usage in the past 6 months | 6 months after randomisation | |
Secondary | Long term follow-up 7-day point prevalence abstinence | 7-day point prevalence abstinence, i.e. current smoking status, Self-report of having smoked no cigarettes in the past seven days | Measured between 12 and 18 months post randomisation |
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