Condition category
Mental and Behavioural Disorders
Date applied
02/04/2015
Date assigned
07/04/2015
Last edited
21/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

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 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

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

Trial setting

Other

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2015

Overall trial end date

31/03/2018

Reason abandoned

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

Other

Age group

Adult

Gender

Both

Target number of participants

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

United Kingdom

Trial participating centre

Queen Mary University of London
E1 4NS
United Kingdom

Trial participating centre

Leicester Stop Smoking Service
LE1 6TH
United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

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

Federal/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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes