Trial Outcomes & Findings for Cessation of Smoking Trial in the Emergency Department (NCT NCT04854616)
NCT ID: NCT04854616
Last Updated: 2026-04-30
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
972 participants
Primary outcome timeframe
6 months after randomisation
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
CoSTED Intervention
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
|
Treatment as Usual
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Overall Study
STARTED
|
484
|
488
|
|
Overall Study
COMPLETED
|
479
|
476
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
| Measure |
CoSTED Intervention
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
|
Treatment as Usual
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
12
|
Baseline Characteristics
Cessation of Smoking Trial in the Emergency Department
Baseline characteristics by cohort
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
Total
n=1944 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.52 years
STANDARD_DEVIATION 13.58 • n=484 Participants
|
40.48 years
STANDARD_DEVIATION 13.72 • n=488 Participants
|
40.50 years
STANDARD_DEVIATION 13.65 • n=972 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=484 Participants
|
187 Participants
n=488 Participants
|
369 Participants
n=972 Participants
|
|
Sex: Female, Male
Male
|
302 Participants
n=484 Participants
|
301 Participants
n=488 Participants
|
603 Participants
n=972 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=484 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=972 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=484 Participants
|
36 Participants
n=488 Participants
|
64 Participants
n=972 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=484 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=972 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=484 Participants
|
28 Participants
n=488 Participants
|
57 Participants
n=972 Participants
|
|
Race (NIH/OMB)
White
|
419 Participants
n=484 Participants
|
406 Participants
n=488 Participants
|
825 Participants
n=972 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=484 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=972 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=484 Participants
|
18 Participants
n=488 Participants
|
26 Participants
n=972 Participants
|
|
Carbon monoxide concentration
|
484 Participants
n=484 Participants
|
488 Participants
n=488 Participants
|
972 Participants
n=972 Participants
|
PRIMARY outcome
Timeframe: 6 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)
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Continuous Smoking Abstinence
|
35 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 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
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
7-day Point Prevalence Abstinence
|
113 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 6 months after randomisationNumerical value
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=486 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Number of Quit Attempts
|
2 Number of quit attempts
Interval 1.0 to 4.0
|
1 Number of quit attempts
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 months after randomisationNumerical value
Outcome measures
| Measure |
CoSTED Intervention
n=314 Participants
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
|
Treatment as Usual
n=283 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Number of Cigarettes Per Day
|
0 Number of cigarette smoked a day
Interval 0.0 to 10.0
|
10 Number of cigarette smoked a day
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: 6 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.
Outcome measures
| Measure |
CoSTED Intervention
n=185 Participants
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
|
Treatment as Usual
n=224 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Nicotine Dependence
|
3.7 score on scale
Standard Deviation 2.21
|
4.17 score on scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 6 months after randomisationNumerical value
Outcome measures
| Measure |
CoSTED Intervention
n=176 Participants
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
|
Treatment as Usual
n=239 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Number of Times Using an E-cigarette Per Day
|
5 Number of E-Cigarettes per day
Interval 0.0 to 10.0
|
0 Number of E-Cigarettes per day
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 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)
Outcome measures
| Measure |
CoSTED Intervention
n=310 Participants
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
|
Treatment as Usual
n=293 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Self-reported Dry Cough or Mouth or Throat Irritation
Score 1-5 (dry cough)1= not at all (best score) to 5= extremely (worst score)
|
1 scores on a scale
Interval 1.0 to 2.0
|
1 scores on a scale
Interval 1.0 to 3.0
|
|
Self-reported Dry Cough or Mouth or Throat Irritation
Score 1-5 (Throat/ Mouth irritation)1= not at all (best score) to 5= extremely (worst score)
|
1 scores on a scale
Interval 1.0 to 2.0
|
1 scores on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 6 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)
Outcome measures
| Measure |
CoSTED Intervention
n=177 Participants
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
|
Treatment as Usual
n=227 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Motivation to Stop Smoking
|
4 scores on a scale
Interval 3.0 to 5.0
|
4 scores on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 6 months after randomisationThe number of participants reporting serious adverse events.
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Adverse Events
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 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
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Smoking Status
|
94 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 3 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
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Smoking Status at 3 Months
|
113 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 6 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
Outcome measures
| Measure |
CoSTED Intervention
n=484 Participants
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
|
Treatment as Usual
n=488 Participants
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Smoking Status at 6 Months
|
113 Participants
|
63 Participants
|
Adverse Events
CoSTED Intervention
Serious events: 25 serious events
Other events: 23 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 25 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CoSTED Intervention
n=310 participants at risk
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
|
Treatment as Usual
n=292 participants at risk
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat/mouth irritation (extreme)
|
8.1%
25/310 • Number of events 25 • from enrolment until end of follow-up up to 6 months
|
8.6%
25/292 • Number of events 25 • from enrolment until end of follow-up up to 6 months
|
Other adverse events
| Measure |
CoSTED Intervention
n=310 participants at risk
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
|
Treatment as Usual
n=292 participants at risk
Signposting to NHS smoking cessation services through provision of written information about local services.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Throat/mouth irritation (extreme)
|
3.2%
10/310 • Number of events 10 • from enrolment until end of follow-up up to 6 months
|
2.7%
8/292 • Number of events 8 • from enrolment until end of follow-up up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough (extreme)
|
4.2%
13/310 • Number of events 13 • from enrolment until end of follow-up up to 6 months
|
4.1%
12/292 • Number of events 12 • from enrolment until end of follow-up up to 6 months
|
Additional Information
Ian Pope
Norfolk and Norwich University Hospitals NHS Foundation Trust
Phone: 01603 286286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place