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.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)