Lynne Dawkins, Kirstie Soar, Francesca Pesola, Allison Ford, Caitlin Notley, Rachel Brown, Emma Ward, Lauren McMillan, Debbie Robson, Anna Varley, Charlotte Mair, Jessica Lennon, Janine Brierley, Amy Edwards, Peter Hajek, Allan Tyler, Steve Parrott, Jinshuo Li, Linda Bauld, Bethany Gardner, Sharon Cox
{"title":"前往无家可归者支持中心(SCeTCH)的人的戒烟:在英国的一项随机对照试验中,比较电子烟与常规护理的提供。","authors":"Lynne Dawkins, Kirstie Soar, Francesca Pesola, Allison Ford, Caitlin Notley, Rachel Brown, Emma Ward, Lauren McMillan, Debbie Robson, Anna Varley, Charlotte Mair, Jessica Lennon, Janine Brierley, Amy Edwards, Peter Hajek, Allan Tyler, Steve Parrott, Jinshuo Li, Linda Bauld, Bethany Gardner, Sharon Cox","doi":"10.1186/s12916-025-04167-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Smoking rates are exceptionally high among people experiencing homelessness. We aimed to test the effectiveness of an e-cigarette (EC) intervention designed to help people accessing homeless support services to stop smoking.</p><p><strong>Methods: </strong>A two-arm cluster randomised controlled trial. We recruited 32 homeless centres (clusters) across Great Britain. Participants were aged 18 + and known by centre staff to smoke. Randomisation of clusters (1:1; using various block sizes) to EC or usual care (UC) was generated in Stata by the trial statistician, concealed from researchers. Participants in EC clusters received a refillable EC, 4-week supply of e-liquid, and a fact sheet. UC participants received very brief advice on smoking, a support leaflet, and signposting to the stop smoking service. Interventions were delivered by centre staff. The primary outcome was sustained abstinence from smoking from 2 weeks post-baseline through to 24 weeks, verified by carbon monoxide (CO) measurements below 8 ppm. Secondary outcomes included CO-verified 7-day point prevalence abstinence. Analysis was intention-to-treat.</p><p><strong>Results: </strong>Between February 22, 2022, and June 22, 2023, 16 centres were randomised to EC (n = 239 participants) and 16 to UC (n = 238 participants). In UC, one participant died, and one withdrew consent. Final sample analysed: n = 239 (EC); n = 236 (UC). Sustained 24-week CO-validated smoking cessation rates were 5/239 (2.1%) with EC vs. 2/236 (0.8%) with UC (aRR: 2.43, 95%CI: 0.51-11.64). Seven-point prevalence abstinence was 15/239 (6.3%) in the EC arm vs. 5/236 (2.1%) in UC (aRR: 2.95, 95%CI: 1.05-8.29). Four adverse events were reported in the EC arm; three deemed EC-related and not serious; one serious and not EC-related.</p><p><strong>Conclusions: </strong>EC did not support sustained smoking abstinence for 24 weeks. Seven-day point prevalence abstinence rates suggest that cessation is possible, but more support may be needed to sustain this.</p><p><strong>Trial registration: </strong>The trial was preregistered on the ISTCTN registry #18566874. Registration date: 12/10/2021.</p>","PeriodicalId":9188,"journal":{"name":"BMC Medicine","volume":"23 1","pages":"394"},"PeriodicalIF":7.0000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220484/pdf/","citationCount":"0","resultStr":"{\"title\":\"Smoking cessation for people accessing homeless support centres (SCeTCH): comparing the provision of an e-cigarette versus usual care in a cluster randomised controlled trial in Great Britain.\",\"authors\":\"Lynne Dawkins, Kirstie Soar, Francesca Pesola, Allison Ford, Caitlin Notley, Rachel Brown, Emma Ward, Lauren McMillan, Debbie Robson, Anna Varley, Charlotte Mair, Jessica Lennon, Janine Brierley, Amy Edwards, Peter Hajek, Allan Tyler, Steve Parrott, Jinshuo Li, Linda Bauld, Bethany Gardner, Sharon Cox\",\"doi\":\"10.1186/s12916-025-04167-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Smoking rates are exceptionally high among people experiencing homelessness. We aimed to test the effectiveness of an e-cigarette (EC) intervention designed to help people accessing homeless support services to stop smoking.</p><p><strong>Methods: </strong>A two-arm cluster randomised controlled trial. We recruited 32 homeless centres (clusters) across Great Britain. Participants were aged 18 + and known by centre staff to smoke. Randomisation of clusters (1:1; using various block sizes) to EC or usual care (UC) was generated in Stata by the trial statistician, concealed from researchers. Participants in EC clusters received a refillable EC, 4-week supply of e-liquid, and a fact sheet. UC participants received very brief advice on smoking, a support leaflet, and signposting to the stop smoking service. Interventions were delivered by centre staff. The primary outcome was sustained abstinence from smoking from 2 weeks post-baseline through to 24 weeks, verified by carbon monoxide (CO) measurements below 8 ppm. Secondary outcomes included CO-verified 7-day point prevalence abstinence. Analysis was intention-to-treat.</p><p><strong>Results: </strong>Between February 22, 2022, and June 22, 2023, 16 centres were randomised to EC (n = 239 participants) and 16 to UC (n = 238 participants). In UC, one participant died, and one withdrew consent. Final sample analysed: n = 239 (EC); n = 236 (UC). Sustained 24-week CO-validated smoking cessation rates were 5/239 (2.1%) with EC vs. 2/236 (0.8%) with UC (aRR: 2.43, 95%CI: 0.51-11.64). Seven-point prevalence abstinence was 15/239 (6.3%) in the EC arm vs. 5/236 (2.1%) in UC (aRR: 2.95, 95%CI: 1.05-8.29). Four adverse events were reported in the EC arm; three deemed EC-related and not serious; one serious and not EC-related.</p><p><strong>Conclusions: </strong>EC did not support sustained smoking abstinence for 24 weeks. Seven-day point prevalence abstinence rates suggest that cessation is possible, but more support may be needed to sustain this.</p><p><strong>Trial registration: </strong>The trial was preregistered on the ISTCTN registry #18566874. Registration date: 12/10/2021.</p>\",\"PeriodicalId\":9188,\"journal\":{\"name\":\"BMC Medicine\",\"volume\":\"23 1\",\"pages\":\"394\"},\"PeriodicalIF\":7.0000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220484/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12916-025-04167-y\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12916-025-04167-y","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Smoking cessation for people accessing homeless support centres (SCeTCH): comparing the provision of an e-cigarette versus usual care in a cluster randomised controlled trial in Great Britain.
Background: Smoking rates are exceptionally high among people experiencing homelessness. We aimed to test the effectiveness of an e-cigarette (EC) intervention designed to help people accessing homeless support services to stop smoking.
Methods: A two-arm cluster randomised controlled trial. We recruited 32 homeless centres (clusters) across Great Britain. Participants were aged 18 + and known by centre staff to smoke. Randomisation of clusters (1:1; using various block sizes) to EC or usual care (UC) was generated in Stata by the trial statistician, concealed from researchers. Participants in EC clusters received a refillable EC, 4-week supply of e-liquid, and a fact sheet. UC participants received very brief advice on smoking, a support leaflet, and signposting to the stop smoking service. Interventions were delivered by centre staff. The primary outcome was sustained abstinence from smoking from 2 weeks post-baseline through to 24 weeks, verified by carbon monoxide (CO) measurements below 8 ppm. Secondary outcomes included CO-verified 7-day point prevalence abstinence. Analysis was intention-to-treat.
Results: Between February 22, 2022, and June 22, 2023, 16 centres were randomised to EC (n = 239 participants) and 16 to UC (n = 238 participants). In UC, one participant died, and one withdrew consent. Final sample analysed: n = 239 (EC); n = 236 (UC). Sustained 24-week CO-validated smoking cessation rates were 5/239 (2.1%) with EC vs. 2/236 (0.8%) with UC (aRR: 2.43, 95%CI: 0.51-11.64). Seven-point prevalence abstinence was 15/239 (6.3%) in the EC arm vs. 5/236 (2.1%) in UC (aRR: 2.95, 95%CI: 1.05-8.29). Four adverse events were reported in the EC arm; three deemed EC-related and not serious; one serious and not EC-related.
Conclusions: EC did not support sustained smoking abstinence for 24 weeks. Seven-day point prevalence abstinence rates suggest that cessation is possible, but more support may be needed to sustain this.
Trial registration: The trial was preregistered on the ISTCTN registry #18566874. Registration date: 12/10/2021.
期刊介绍:
BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.