Offering e-cigarettes for smoking cessation and reduction in people with mental illness (ESCAPE):protocol for a randomised controlled trial

Background and Aims: Despite a steady decline in smoking rates across the UK over the past decades, substantial tobacco-related inequalities persist, particularly among individuals with mental illness. Smoking prevalence in this group has remained largely unchanged, highlighting a major public health concern. This protocol outlines a trial aimed at addressing this issue by evaluating the effectiveness of offering an electronic cigarette (e-cigarette) starter kit for smoking cessation and harm reduction as an adjunct to usual care to adults who smoke with mental illness treated in the community. Design: Two-arm parallel randomised controlled superiority trial. Setting: A minimum of eleven UK National Health Service mental health Trusts or general practices. Participants: Adults who smoke with a diagnosis of mental illness treated in the community. Intervention and comparator: Participants will be randomly allocated (1:1) to either receive an e-cigarette starter kit, a brief demonstration, and both verbal and written information on e-cigarette use as an adjunct to usual care or usual care alone. Measurements: The primary outcome is 7-day point prevalence carbon monoxide-validated abstinence, assessed six months after study enrolment or target quit date. Secondary outcomes include: 6-month continuous abstinence defined by Russell Standard, self-reported smoking abstinence at 1-month, ≥50% smoking reduction (cigarettes/day) at 1- and 6-months, mental health symptoms and general mood and physical symptoms at 1- and 6-months, cost-effectiveness of the intervention and adherence to and satisfaction with the intervention. Comments: This will be the first large-scale study in the UK to assess the effectiveness and cost-effectiveness of providing an e-cigarette starter kit for smoking cessation and harm reduction in people with mental illness. Results will inform policy and practice related to supporting smoking cessation for this population.