ESCAPE RCT
Research type
Research Study
Full title
E-cigarettes for Smoking Cessation And reduction in People with mEntal illness (ESCAPE trial)
IRAS ID
328528
Contact name
Lion Shahab
Contact email
Sponsor organisation
The university of York
Duration of Study in the UK
1 years, 7 months, days
Research summary
The aim of our study is to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit to people with a mental illness (PWMI) treated in the community to aid smoking cessation and harm reduction, as an adjunct to ‘usual care’.
This RCT will compare the intervention (e-cigarette starter kit as an adjunct to usual care) and control groups (usual care) at 1-month and 6-month follow-up. Participants will include adults (≥ 18 years) currently receiving treatment for a mental illness in secondary or, depending on availability, primary care. The target sample size for the RCT is 616, with 308 participants allocated to each group. Participants will be randomized to either the treatment or control group. Both groups will receive brief advice to stop smoking. In addition, the treatment group will be offered a DOT PRO e-cigarette starter kit (www.liberty-flights.co.uk/DOT-PRO/DOT-PRO-Vape-Kit/), compliant with EU regulation, and an information leaflet about e-cigarettes, in addition to usual care. The primary clinical outcome measure, continuous abstinence, will be assessed at 1 and 6 months, verified by a CO reading below 10 ppm at 6-month follow-up. Secondary outcomes include changes in cigarette consumption, in mental and physical health indices, incidence of adverse events, and cost effectiveness of the intervention.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
23/YH/0199
Date of REC Opinion
26 Oct 2023
REC opinion
Further Information Favourable Opinion