The efficacy of e-cigarettes compared with nicotine replacement therapy, when used within the UK stop smoking service

ISRCTN	ISRCTN60477608
DOI	https://doi.org/10.1186/ISRCTN60477608
Secondary identifying numbers	HTA 12/167/135

Submission date: 02/04/2015
Registration date: 07/04/2015
Last edited: 18/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-electronic-cigarettes-with-nicotine-replacement-therapy-to-stop-smoking-tec

Contact information

Miss Anna Phillips
Public

2 Stayner's Road
London
E1 4AH
United Kingdom

Phone	+44 (0)207 882 5747
Email	a.phillips@qmul.ac.uk

Study information

Study design	Multicentre pragmatic randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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
Study 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
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

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	886
Total final enrolment	886
Participant inclusion criteria	1. Aged 18 or over 2. Current smoker accessing the stop smoking service 3. Able to read/write/understand English
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 centres

Queen Mary University of London

E1 4NS
United Kingdom

Leicester Stop Smoking Service

LE1 6TH
United Kingdom

East Sussex Stop Smoking Service

TN38 9UH
United Kingdom

Sponsor information

Queen Mary University of London (QMUL)
University/education

Queen Mary Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom

"ROR"	https://ror.org/026zzn846

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The results of the study will be published in a peer-reviewed scientific journals and presented at conferences.
IPD sharing plan	Not provided at time of registration

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

Additional files

ISRCTN60477608 SAP v1.0 08Jan2018.pdf
ISRCTN60477608 Protocol v3.0 08Apr2015.pdf

Editorial Notes

18/08/2022: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
25/02/2020: Link to basic results added to results (plain English)
23/08/2019: Publication reference and total final enrolment number added.
04/03/2019: Publication reference added.