Contact information
Type
Public
Contact name
Miss Anna Phillips
ORCID ID
Contact details
2 Stayner's Road
London
E1 4AH
United Kingdom
+44 (0)207 882 5747
a.phillips@qmul.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
HTA 12/167/135
Study information
Scientific title
A randomised controlled trial to examine the efficacy of e-cigarettes compared with nicotine replacement therapy, when used within the UK stop smoking service
Acronym
TEC (Trial of Electronic Cigarettes)
Study hypothesis
To determine the 12-month sustained biochemically validated abstinence rates in smokers using electronic cigarettes (EC) compared to smokers using standard nicotine replacement therapy (NRT).
More details can be found at http://www.nets.nihr.ac.uk/projects/hta/12167135
Ethics approval(s)
NRES Committee London Camden & Islington, 14/LO/2235, 19/12/2014
Study design
Multicentre pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Smoking cessation
Intervention
Smokers who want help to quit smoking will be individually randomised to receive usual care (UC; a choice of NRT combined with usual care behavioural support provided by a Stop Smoking Service) or EC with the same behavioural support.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
Carbon monoxide (CO) validated sustained abstinence rates at 52 weeks post–target quit date (TQD)
Secondary outcome measures
1. CO validated sustained abstinence rates at 4 and 24 weeks post–TQD
2. 7-day point prevalence abstinence at 4, 24 and 52 weeks
3. Smoking reduction in participants who did not achieve full abstinence
4. Treatment ratings
5. Adverse reactions
6. Cost-efficacy of the interventions
Overall study start date
01/04/2015
Overall study end date
31/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or over
2. Current smoker accessing the stop smoking service
3. Able to read/write/understand English
Participant type(s)
Other
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
886
Total final enrolment
886
Participant exclusion criteria
1. Pregnant or breastfeeding
2. Strong preference to use or not to use NRT or EC in their quit attempt
3. Enrolled in other interventional research
4. Currently using NRT or EC
Recruitment start date
15/04/2015
Recruitment end date
01/12/2016
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Queen Mary University of London
E1 4NS
United Kingdom
Study participating centre
Leicester Stop Smoking Service
LE1 6TH
United Kingdom
Study participating centre
East Sussex Stop Smoking Service
TN38 9UH
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (QMUL)
Sponsor details
Queen Mary Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of the study will be published in a peer-reviewed scientific journals and presented at conferences.
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/02/2019 | Yes | No | |
| Results article | results | 01/08/2019 | 23/08/2019 | Yes | No |
| Plain English results | 25/02/2020 | No | Yes | ||
| Protocol file | version 3.0 | 08/04/2015 | 18/08/2022 | No | No |
| Statistical Analysis Plan | version 1.0 | 08/01/2018 | 18/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |