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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	HTA 12/167/135
Sponsor	Queen Mary University of London (QMUL)
Funder	Health Technology Assessment Programme

Submission date: 02/04/2015
Registration date: 07/04/2015
Last edited: 24/06/2025

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 of protocol

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

Primary study design	Interventional
Study design	Multicentre pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Electronic cigarettes, nicotine replacement therapy
Primary outcome measure(s)	Carbon monoxide (CO) validated sustained abstinence rates at 52 weeks post–target quit date (TQD)
Key secondary outcome measure(s)	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
Completion date	31/03/2018

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	886
Total final enrolment	886
Key inclusion criteria	1. Aged 18 or over 2. Current smoker accessing the stop smoking service 3. Able to read/write/understand English
Key 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
Date of first enrolment	15/04/2015
Date of final enrolment	01/12/2016

Locations

Countries of recruitment

United Kingdom
England

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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
Results article	Costs effectiveness	04/12/2019	24/06/2025	Yes	No
HRA research summary			28/06/2023	No	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

Additional files

ISRCTN60477608 SAP v1.0 08Jan2018.pdf: Statistical Analysis Plan
ISRCTN60477608 Protocol v3.0 08Apr2015.pdf: Protocol file

Editorial Notes

24/06/2025: Publication reference added.
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.