Dimitra Kale, Emma Beard, Yan Ding, Jodi Pervin, Qi Wu, Catherine Arundel, Steve Parrott, Paul Galdas, Michelle Horspool, Simon Hough, Gregor Russell, Suzy Ker, Elena Ratschen, Lion Shahab
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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.</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>Two-arm parallel randomized controlled superiority trial.</p>\n </section>\n \n <section>\n \n <h3> Setting</h3>\n \n <p>A minimum of eleven UK National Health Service mental health Trusts or general practices.</p>\n </section>\n \n <section>\n \n <h3> Participants</h3>\n \n <p>Adults who smoke with a diagnosis of mental illness treated in the community.</p>\n </section>\n \n <section>\n \n <h3> Intervention and comparator</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Measurements</h3>\n \n <p>The primary outcome is 7-day point prevalence carbon monoxide-validated abstinence, assessed six months after study enrolment or target quit date. 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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.
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.
期刊介绍：
Addiction publishes peer-reviewed research reports on pharmacological and behavioural addictions, bringing together research conducted within many different disciplines.
Its goal is to serve international and interdisciplinary scientific and clinical communication, to strengthen links between science and policy, and to stimulate and enhance the quality of debate. We seek submissions that are not only technically competent but are also original and contain information or ideas of fresh interest to our international readership. We seek to serve low- and middle-income (LAMI) countries as well as more economically developed countries.
Addiction’s scope spans human experimental, epidemiological, social science, historical, clinical and policy research relating to addiction, primarily but not exclusively in the areas of psychoactive substance use and/or gambling. In addition to original research, the journal features editorials, commentaries, reviews, letters, and book reviews.
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