Condition category
Mental and Behavioural Disorders
Date applied
17/03/2017
Date assigned
23/03/2017
Last edited
22/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Current treatments for smokers do not typically address the behaviours and sensations associated with the act of smoking (e.g. handling a cigarette, inhaling, taste and feel of smoke on the throat). Electronic cigarettes (EC) are battery-operated devices that attempt to mimic the act of smoking and so provide these effects. EC can alleviate urges to smoke, but it is not known whether they are as effective at helping smokers who want to cut down on their smoking and quit as the existing stop-smoking medicines (e.g. nicotine replacement treatment (NRT)). The aim of this study is to compare the effectiveness of two different stop-smoking strategies: an electronic cigarette (EC) or a nicotine-replacement product (NRT).

Who can participate?
People at least 18 years old, who have failed to stop smoking with stop-smoking services and/or products in the past

What does the study involve?
Information is collected about participants’ smoking, mood and health, and the amount of carbon monoxide (CO) in their breath is measured (this shows how much smoke they inhale). Participants are then randomly allocated to use EC or NRT for at least 4 weeks. All participants are contacted by phone at weeks 1, 4 and 24 and asked questions about their mood, smoking and the use of their allocated product. Those who have reduced their smoking by 50% or more at weeks 4 and 24 are invited to the clinic for a CO reading and are given £10 towards the travel cost.

What are the possible benefits and risks of participating?
Participants receive either NRT or EC with behavioural support which they might find beneficial in helping them to quit or reduce their smoking. No risks are expected from using EC or NRT. Neither contain tobacco, and therefore do not deliver the many harmful substances found in normal cigarettes. As a result they pose no increased risk compared to normal cigarettes. The most common side effects that people report experiencing when using EC or NRT are mouth and throat irritation, nausea and sleep disturbance. The EC provided are not currently licensed as a medicine, but they are regulated as a consumer product.

Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
January 2017 to January 2018

Who is funding the study?
Cancer Research UK

Who is the main contact?
Ms Marzena Orzol
m.orzol@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marzena Orzol

ORCID ID

Contact details

Health and Lifestyle Research Unit
2 Stayner's Road
London
E1 4AH
United Kingdom
+44 (0)207 882 8227
m.orzol@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

QMERC2016/65

Study information

Scientific title

Can electronic cigarettes and nicotine replacement treatment help reduce smoking in smokers who struggle to quit? A pilot randomised control trial

Acronym

EC-CRUK

Study hypothesis

The aim of the study is to examine over six months the smoking behaviour of smokers unable to stop smoking with conventional methods who are randomised to two harm-reduction strategies: an electronic cigarette of their choice or a nicotine-replacement product of their choice.

Ethics approval

The Queen Mary Ethics of Research Committee (Panel E), 22/02/2017, ref: QMERC2016/65

Study design

Pilot single-centre randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Smoking cessation

Intervention

Participants will be invited to attend two appointments as follows:
Visit 1 - Screening for eligibility, baseline data collection and randomisation. Smokers attend to confirm eligibility, have questions answered, and provide consent. Baseline data collected. Participants randomised to EC or NRT, select products of their choice and receive instructions on how to obtain them. Continue to smoke ad-lib.

Visit 2 – Preparation
Smokers bring allocated product to the session, receive advice on use, test and start product use. Commitment to not using unallocated products for the next four weeks. Smoking reduction counselling will be provided.

Participants will be randomised to two different study arms: NRT group and e-cigarette group. Randomisation (1:1 in blocks of 20) will be undertaken using computer generated randomisation codes that will be prepared in advance. Codes will be sealed in opaque envelopes that will be marked with a randomisation number. Randomisation numbers will be allocated sequentially. The staff randomising the participant will open the envelope and enter the allocation onto the clinical record form (CRF).

NRT group product details
Those allocated to the NRT group will be shown and explained the NRT products available and encouraged to choose a product or product combination that suits their needs. They will receive a letter of recommendation (LOR) as per standard practice and collect their chosen products at local pharmacies. Product use will be supervised and adjusted (if required) as part of the behavioural support package. As per local standard practice, NRT will be provided for up to 8 weeks.

EC group product details
Those allocated to the EC group will be shown and explained different EC products commonly used and asked to obtain the product of their choice either using a voucher for up to £35 to purchase EC at a local vape shop, purchase from other suppliers and claim a refund of up to £35 upon providing a valid receipt, or choose from a limited selection at the smoking cessation clinic. They will be encouraged to try different products and liquids if the first purchase does not meet their needs, but after the initial purchase, participants will fund further supplies themselves (this is to mimic the provision of starter packs, an approach that is most likely to be used by routine services).

Participants will be contacted by phone at 1 week, 4 weeks and 24 weeks after the initial screening session when their smoking behaviour and NRT/e-cigarette use will be assessed. Those who will report ≥50% smoking reduction will be invited to provide a CO reading in the clinic.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Cigarette consumption per day, assessed by self-report in the follow up survey created for the purpose of the study at 1, 4 and 24 weeks post quit date/preparation date. Those who will report ≥50% smoking reduction will be validated with a CO reading in the clinic.

Secondary outcome measures

1. Use of allocated harm reduction strategies
2. Strategy ratings
3. Changes in smoking behaviour
4. Proportion of people still using allocated strategy at 6 months
All measured by the follow up survey created for the purpose of the study at 1, 4 and 24 weeks post quit date/preparation date

Overall trial start date

01/01/2017

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older
2. Able to provide written informed consent
3. History of failed quit attempts using stop smoking medications and/or stop smoking services
4. Willing to use their allocated harm-reduction strategy for at least 4 weeks

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Women who are pregnant or breastfeeding
2. Unable to read/write/understand English
3. Currently using EC or any stop smoking products
4. Taking part in other interventional research
5. Have a strong preference to use or not to use NRT or EC

Recruitment start date

04/04/2017

Recruitment end date

04/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary University of London
Health and Lifestyle Research Unit
London
E1 4AH

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study results will be:
1. Published in a peer-reviewed medical journal, in Open Access format
2. Presented at international conferences on tobacco control and public health (e.g. Society for Research on Nicotine and Tobacco (SRNT) Annual Conference; European Respiratory Society Annual Congress)
3. Translated for the lay audience in collaboration with our Patient Group and communicated through the QMUL press office and the UK Centre for Tobacco and Alcohol Studies in a range of press and digital formats
4. Communicated in lay format through various electronic cigarette consumer organisations (e.g. the Electronic Cigarettes Consumer Association of the UK)
5. Integrated into national and international guidelines and training programmes for smoking cessation specialists
6. Directly communicated to key government, NHS, and public health stakeholders
7. Communicated over specialist tobacco control networks (e.g. SRNT, Association for the Treatment of Tobacco Use and Dependence)

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Anna Phillips (a.phillips@qmul.ac.uk)

Intention to publish date

01/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes