E-cigarettes for smoking cessation and reduction in people with a mental illness
| ISRCTN | ISRCTN14068059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14068059 |
| IRAS number | 328528 |
| Secondary identifying numbers | CPMS 58155, IRAS 328528 |
- Submission date
- 20/06/2023
- Registration date
- 05/01/2024
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Tobacco smoking is the single largest contributor to health inequalities for people with mental illness (PWMI). Developing and implementing ways to address this widening health gap has been identified as a priority in the NHS Long Term Plan and the 2019 Tobacco Control Plan for England. E-cigarettes have been suggested as a potentially particularly helpful way to support people with mental illness quit smoking or substantially reduce consumption. However, there have been no fully powered trials to assess this potential. The researchers completed a feasibility study in January 2023 and are now ready to proceed to a full randomised controlled trial (RCT). The aim of this study is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to PWMI treated in the community to aid smoking cessation and harm reduction.
Who can participate?
Adults (aged over 18 years) receiving treatment for a mental illness in primary or secondary care, who smoke regularly
What will the study involve?
Participants are randomly allocated to one of two groups. Group 1 will receive an e-cigarette and e-liquid to use for 4 weeks in addition to the usual care they are receiving. In Group 2, initially participants will continue to receive their care as usual but will receive an e-cigarette and some e-liquid at the end of the study at the 6-month follow-up.
Participants who are assigned to the group that receives the e-cigarette will be given an e-cigarette starter kit (an e-cigarette containing e-liquid and an information leaflet). They will also receive a brief face-to-face consultation with a clinician, who will explain how to use the e-cigarette and provide information to enable participants to make positive changes to their smoking behaviour. Participants will be provided with an e-liquid supply for 4 weeks. Participants who are assigned to the group that does not receive an e-cigarette will continue to receive their usual care package and will be provided with an e-cigarette and some e-liquid after the 6-month follow-up. Both groups will be encouraged to consider quitting and to set a target quit date soon. However, if they choose not to set a quit date that is also okay.
A member of the research team will ask several questions at the beginning of the study and again after 1 and 6 months. Participants will be given the opportunity to do this at home on an electronic device (by completing the questionnaires online) or in person at a place to suit them; this process may take up to 1 hour. The questions will ask about current smoking status, smoking habits and mental and physical health. Participants may also be asked to breathe into a carbon monoxide monitor which can be done at a place that is convenient for them.
What are the possible benefits and risks of participating?
Participants may make positive changes to their smoking behaviour and provide data which could help thousands of smokers to quit smoking for good. They will receive a shopping voucher each time they complete the follow-up questionnaires and receive an e-cigarette which they can keep.
Where is the study run from?
Mental Health Trusts and GP practices mainly in Yorkshire (UK)
When is the study starting and how long is it expected to run for?
March 2023 to July 2025
Who is funding the study?
Yorkshire Cancer Research (UK)
Who is the main contact?
Dr Anna-Marie Marshall, a.marshall@york.ac.uk
Contact information
Principal Investigator
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 320000 |
|---|---|
| elena.ratschen@york.ac.uk |
Principal Investigator
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
| Phone | +44 (0)20 7679 1805 |
|---|---|
| lion.shahab@ucl.ac.uk |
Scientific
Department of Health Sciences
Faculty of Sciences
Area 4, Alcuin Research Resource Centre
University of York
Heslington
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-8439-9682 |
|---|---|
| Phone | +44 (0)1904 32 5600 |
| yan.ding@york.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | E-cigarettes for Smoking Cessation And reduction in People with mEntal illness (ESCAPE) |
| Study acronym | ESCAPE |
| Study hypothesis | The main aim is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to people with mental Illness (PWMI) treated in the community to aid smoking cessation and harm reduction, as an adjunct to ‘usual care’. |
| Ethics approval(s) | Approved 24/10/2023, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8021; southyorks.rec@hra.nhs.uk), ref: 23/YH/0199 The ethical approval covers a process evaluation and the process evaluation started on 17/02/2025 and will be ended on 31/08/2025. We submitted a substantial amendment to IRAS to enable the main trial's ethical approval to cover the process evaluation. We received a favorable opinion from the REC regarding this amendment on 10 February 2025 and a HRA and HCRW approval on 14 February 2025. |
| Condition | Smoking cessation using an e-cigarette in patients living in the community who have a mental illness |
| Intervention | The intervention allocation will be determined by block computer randomisation to ensure that each trial site has an equal proportion of intervention and control group participants. Randomisation will occur after consent to take part in the study has been obtained via sealed envelope. The intervention group will be offered an e-cigarette starter kit, compliant with EU regulation, and an information leaflet about e-cigarettes, in addition to usual care. A 20 mg/ml strength DOTPRO e-cigarette starter kit (https://www.liberty-flights.co.uk/DOT-PRO/DOT-PRO-Vape-Kit/) will be offered in a choice of flavours. The starter kit containing a pod-based e-cigarette, a 4-week supply of refill pods and an information leaflet will be provided to participants by their clinician at their scheduled appointment. At the scheduled appointment with a clinician, a brief consultation will also be conducted with participants to provide necessary instructions for the use of the kit lasting between 5-10 minutes. All participants will be encouraged to consider quitting and to set a target quit date within a week, told that smoking cessation is beneficial for their mental and physical health and that e-cigarettes are a safe and effective way to achieve smoking cessation. The control group will receive care as usual, as outlined above and they will be told that smoking cessation is beneficial for their mental and physical health. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ICON e-cigarette |
| Primary outcome measure | 1. Self-reported 7-day point prevalence abstinence measured using a questionnaire (question written in-house) at 6 months 2. Co-verified quit (main outcome) measured using a CO monitor (smokylizer) at 6 months |
| Secondary outcome measures | 1. General smoking-related characteristics, abstinence, quit attempts and methods (including e-cigarettes), measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 2. Nicotine dependence measured using the Fagerstrom Test for Nicotine Dependence at baseline, 1 month and 6 months 3. Strength of urges to smoke measured using the SUTS questionnaire at baseline, 1 month and 6 months 4. Motivation to quit measured using the Motivation To Stop Scale (MTSS) at baseline, 1 month and 6 months 5. Mental wellbeing measured using PHQ-9 and GAD-7 at baseline and 6 months 6. Alcohol use measured using AUDIT-C at baseline and 6 months 7. Health-related quality of life measured using EQ-5D-5L at baseline and 6 months 8. Attrition measured using a questionnaire (questions written in-house) at 1 month and 6 months 9. Adherence rate measured using a questionnaire (questions written in-house) at 1-month follow-up 10. Cost-effectiveness measured using a questionnaire (questions written in-house) at baseline, 1 month and 6 months 11. Adverse events measured using a questionnaire (questions written in-house) at 1 month and 6 months |
| Overall study start date | 01/03/2023 |
| Overall study end date | 05/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 616 |
| Total final enrolment | 95 |
| Participant inclusion criteria | 1. Adults (aged >18 years) 2. Receiving treatment for a mental illness in primary or secondary care 3. Smokes regularly and have smoked combustible cigarettes in the past 7 days) 4. Must be willing to address their smoking behaviour, either by attempting to quit or by reducing their consumption 5. Must have the capacity to provide consent |
| Participant exclusion criteria | 1. Patients must not have had an inpatient admission in the last 3 months 2. Smokers who are currently using e-cigarettes regularly (at least weekly) 3. Patients who are participating in other smoking cessation trials 4. Patients who are receiving treatment for drug or alcohol use 5. Patients who have a diagnosis of Alzheimer’s disease or dementia 6. Patients who are pregnant or breastfeeding |
| Recruitment start date | 27/03/2024 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Victoria Road
Saltaire
Shipley
BD18 3LD
United Kingdom
Darnall
Sheffield
S9 4EU
United Kingdom
Sandford Road
Littlemore
Oxford
OX4 4XN
United Kingdom
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Sceptre Way
Walton Summit
Preston
PR5 6AW
United Kingdom
Trust Headquarters
Martineau Lane
Norwich
NR1 2DH
United Kingdom
Regent Point
Regent Farm Road
Gosforth
Newcastle Upon Tyne
NE3 3HD
United Kingdom
Rotherham
S61 1AH
United Kingdom
Rotherham
S65 1DA
United Kingdom
Southfields Road
Strensall
York
YO32 5UA
United Kingdom
34 Queen Street
Mosborough
Sheffield
S20 5BQ
United Kingdom
Woodland Avenue
Goole
DN14 6RU
United Kingdom
Sunderland
SR5 2LT
United Kingdom
Sunderland
SR3 4HG
United Kingdom
Butt Lane
Snaith
Goole
DN14 9DY
United Kingdom
Sponsor information
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 320000 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | http://www.york.ac.uk/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results from the feasibility and full RCT will be shared with study participants via email or text message, which will include a link to blog posts regarding study results. PH and SH, together with lay representatives of the steering committee will assist in ensuring that blog posts and other relevant approaches to dissemination are understandable to a lay audience and will also assist with dissemination (e.g. via social media). If they wish to, participants can also assist with dissemination, and we will work together to prepare social media/blog posts that they can share. The researchers will also work with local press (e.g. Yorkshire Post, Sheffield Star, Doncaster Free Press newspapers) to communicate study results to the local population. In addition, we will approach media offices of Universities and Trusts involved in the study and the Yorkshire and Humber CRN to disseminate study results internally. At the national level, the researchers aim to publicise study results through their partners (ASH, NSCST and Equally Well) as well as their contacts within Public Health England and NICE. At the international level, findings from both the feasibility and full RCT will be presented at relevant conferences (Society for Research of Nicotine and Tobacco; Society of Behavioral Medicine, Royal College of Psychiatrists etc) and the publication of study protocol, and results from both trials in high impact, relevant journal (e.g. JAMA Psychiatry, Lancet Psychiatry). Further, the researchers will plan a media briefing with the Science and Media Centre with whom we have a good working relationship. |
| IPD sharing plan | Data will be available upon request from Dr Anna-Marie Marshall (a.marshall@york.ac.uk). Consent from participants was required and obtained. Participants will be allocated a participant number, the names of participants will not appear on the paper-based or online data stored at the University. The NHS code of confidentiality will be adhered to for all patient data and for data. |
Editorial Notes
09/04/2025: The overall study end date was changed from 30/04/2025 to 05/07/2025.
19/02/2025: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 30/04/2025 to 31/12/2024.
3. The study participating centre Magna Group Practice was removed and Bridge View Medical Group, Springwell Medical Group, Snaith and Rawcliffe Medical Group were added.
4. Additional information regarding the ethics approval was added.
21/08/2024: The following changes were made to the study record:
1. The device name was changed from DOTPRO e-cigarette to ICON e-cigarette.
2. The recruitment end date was changed from 31/03/2025 to 30/04/2025.
3. The study participating centres were updated to remove Greater Manchester Mental Health NHS Foundation Trust, CRN East of England, The Burns Practice and Conisborough Medical Practice and add Clifton Medical Centre, My Health, Magna Group Practice, Mosborough Health Centre, and Bartholomew Medical Group.
03/04/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2024 to 27/03/2024.
2. The study participating centres Oxford NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, South West Yorkshire Partnership NHS Foundation Trust, Nottinghamshire Healthcare NHS Foundation Trust, Lancashire and South Cumbria NHS Foundation Trust, Norfolk and Suffolk NHS Foundation Trust, CRN North East and North Cumbria, CRN East of England, The Burns Practice, Conisborough Medical Practice, Woodstock Bower Surgery were added.
07/02/2024: Ethics approval details added. The recruitment start date was changed from 01/10/2023 to 01/03/2024.
06/02/2024: Contact details added.
21/06/2023: Study's existence confirmed by Yorkshire Cancer Research.
