ESCAPE Trial

  • Research type

    Research Study

  • Full title

    E-cigarettes for Smoking Cessation And reduction in People with mEntal illness - a randomised pilot feasibility trial

  • IRAS ID

    303022

  • Contact name

    Lion Shahab

  • Contact email

    lion.shahab@ucl.ac.uk

  • Sponsor organisation

    The university of York

  • ISRCTN Number

    ISRCTN17691451

  • Duration of Study in the UK

    1 years, 0 months, 0 days

  • Research summary

    The proportion of people with mental illness (PWMI) who smoke tobacco is very high compared with the general population. Smoking causes disease and deaths among PWMI, who lose up to 20 years of life mainly to the consequences of smoking. Although PMWI are similarly motivated to quit as people without mental illness, giving up smoking can be difficult for PWMI because of limited access to support and high dependence. There is a clear need to develop better support strategies for this population. Electronic cigarettes (e-cigarettes), which deliver nicotine without most of the harmful substances in tobacco smoke, have been recognized as a potentially helpful tool for quitting. With Funding from Yorkshire Cancer Research, the ESCAPE trial will assess whether offering PWMI e-cigarettes in addition to standard support is better than standard support alone. We aim to conduct a randomised controlled feasibility trial over a 12-month period offering an e-cigarette starter kit (4-week supply and explanatory leaflet) as an adjunct to usual care for smokers with mental illness treated in the community. Based on our insights, we will then decide whether to conduct a full randomized controlled trial, which is not part of this application). Participants will include adults (> 18 years) receiving treatment for a mental illness under the care at three Mental Health Trusts. Follow-up will take place after 1 month; questionnaires (including socio-demographic characteristics, smoking-related characteristics, general and mental health-related characteristics, health behaviour characteristics and feasibility, and acceptability outcomes) will be completed either electronically, at an existing appointment or by telephone. Abstinence, using carbon monoxide readings will be conducted via home visit or at an appropriate community venue. Qualitative interviews (approximately 18 participants and 6 clinicians) will also be conducted to gain insights into patients’ experience with the intervention and barriers to and facilitators of success.

  • REC name

    North East - York Research Ethics Committee

  • REC reference

    21/NE/0202

  • Date of REC Opinion

    15 Dec 2021

  • REC opinion

    Further Information Favourable Opinion