Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial.
Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological...
| Publicado en: | Internal & Emergency Medicine Vol. 14; no. 6; pp. 885 - 899 |
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| Autores principales: | , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Springer Nature
Sep2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=138414702&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 138414702 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 18280447 46A5 jtl: Internal & Emergency Medicine issn: 18280447 maglogo: N pubinfo: dt: Sep2019 vid: 14 iid: 6 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 138414702 138414702 144169927 NLM31049783 10.1007/s11739-019-02090-8 NLM31049783 138414702 ppf: 885 ppct: 14 formats: tig: atl: Evaluating the effects of switching from cigarette smoking to using a heated tobacco product on health effect indicators in healthy subjects: study protocol for a randomized controlled trial. aug: au: Newland, Nik Lowe, Frazer John Camacho, Oscar Martin McEwan, Mike Gale, Nathan Ebajemito, James Hardie, George Murphy, James Proctor, Christopher affil: Group Research and Development, British American Tobacco (Investments) Ltd., Regents Park Road, SO15 8TL, Southampton, UK sug: subj: Nicotine Analysis Research Subjects Statistics and Numerical Data Nicotine Blood Middle Age Male Adult Female Tobacco Products Impact of Events Scale Scales Middle Aged: 45-64 years Adult: 19-44 years Male Female ab: Tobacco heating products (THPs) are a potentially safer alternative to combustible cigarette smoking. Through continued use, THPs may reduce smoking-related disease risk, whilst maintaining the sensorial experience and nicotine delivery sought by smokers. While literature evidence of the biological effects of THP aerosol exposure is increasing, there remains a knowledge gap with respect to substantiation of THP reduced risk potential in longer term real-life use. This randomized, multi-centre, controlled clinical study will test the hypotheses that following a switch from combustible cigarettes to a THP for 1 year, participants will experience a sustained reduction in exposure to tobacco-related toxicants that will lead to favourable changes in health effect indicators associated with smoking-related disease development. Changes in such indicators will be contextualized against smoking cessation and never-smoker cohorts. Up to 280 participants who do not intend to quit smoking will be randomized to continued combustible smoking (arm A, up to n = 80) or a commercially available THP (arm B n = 200). Furthermore, up to 190 participants with a high intent to quit smoking will undergo smoking cessation (arm D), and 40 never smokers will serve as a control group (arm E). Recruitment numbers were determined to be sufficient to achieve n = 50 in arms A, B and D, at study end. Enrolment started in March 2018 and the trial is scheduled to be completed in March 2020. Data from this study will be a valuable addition to the growing body of evidence in the field of understanding the individual and public health impact of THPs.Clinical Trial Registration: https://www.isrctn.com/ISRCTN81075760. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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