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

BACKGROUND AND AIMS: Despite a steady decline in smoking rates across the United Kingdom (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 randomized 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 receive: (i) 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 (ii) 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.