Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol

dc.contributor.authorWall, Catherine S.en
dc.contributor.authorBono, Rose S.en
dc.contributor.authorLester, Rebecca C.en
dc.contributor.authorHoetger, Cosimaen
dc.contributor.authorLipato, Thokozenien
dc.contributor.authorGuy, Mignonne C.en
dc.contributor.authorEissenberg, Thomas E.en
dc.contributor.authorBickel, Warren K.en
dc.contributor.authorBarnes, Andrew J.en
dc.contributor.authorCobb, Caroline O.en
dc.date.accessioned2021-10-20T11:53:47Zen
dc.date.available2021-10-20T11:53:47Zen
dc.date.issued2018-10-01en
dc.date.updated2021-10-20T11:53:45Zen
dc.description.abstractIntroduction In the USA, Food and Drug Administration regulations prohibit the sale of flavoured cigarettes, with menthol being the exception. However, the manufacture, advertisement and sale of flavoured cigar products are permitted. Such flavourings influence positive perceptions of tobacco products and are linked to increased use. Flavourings may mask the taste of tobacco and enhance smoke inhalation, influencing toxicant exposure and abuse liability among novice tobacco users. Using clinical laboratory methods, this study investigates how flavour availability affects measures of abuse liability in young adult cigarette smokers. The specific aims are to evaluate the effect of cigar flavours on nicotine exposure, and behavioural and subjective measures of abuse liability. Methods and analyses Participants (projected n=25) are healthy smokers of five or more cigarettes per day over the past 3 months, 18-25 years old, naive to cigar use (lifetime use of 50 or fewer cigar products and no more than 10 cigars smoked in the past 30 days) and without a desire to quit cigarette smoking in the next 30 days. Participants complete five laboratory sessions in a Latin square design with either their own brand cigarette or a session-specific Black & Mild cigar differing in flavour (apple, cream, original and wine). Participants are single-blinded to cigar flavours. Each session consists of two 10-puff smoking bouts (30 s interpuff interval) separated by 1 hour. Primary outcomes include saliva nicotine concentration, behavioural economic task performance and response to various questionnaire items assessing subjective effects predictive of abuse liability. Differences in outcomes across own brand cigarette and flavoured cigar conditions will be tested using linear mixed models. Ethics and dissemination The Virginia Commonwealth University Institutional Review Board approved the study (VCU IRB: HM20007848). Dissemination channels for study findings include scientific journals, scientific meetings, and policy briefs.en
dc.description.versionPublished versionen
dc.format.extent8 page(s)en
dc.format.mimetypeapplication/pdfen
dc.identifierARTN e023850 (Article number)en
dc.identifier.doihttps://doi.org/10.1136/bmjopen-2018-023850en
dc.identifier.eissn2044-6055en
dc.identifier.issn2044-6055en
dc.identifier.issue10en
dc.identifier.orcidBickel, Warren [0000-0002-1048-7372]en
dc.identifier.otherbmjopen-2018-023850 (PII)en
dc.identifier.pmid30309993en
dc.identifier.urihttp://hdl.handle.net/10919/105421en
dc.identifier.volume8en
dc.language.isoenen
dc.publisherBMJen
dc.relation.urihttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000454739500165&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=930d57c9ac61a043676db62af60056c1en
dc.rightsCreative Commons Attribution-NonCommercial 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectLife Sciences & Biomedicineen
dc.subjectMedicine, General & Internalen
dc.subjectGeneral & Internal Medicineen
dc.subjectTRANSDERMAL NICOTINEen
dc.subjectTOBACCO PRODUCTSen
dc.subjectUNITED-STATESen
dc.subjectPURCHASE TASKen
dc.subjectPUFF TOPOGRAPHYen
dc.subjectYOUNG-ADULTSen
dc.subjectSMOKINGen
dc.subjectEXPOSUREen
dc.subjectDEMANDen
dc.subjectCONSUMPTIONen
dc.subjectabuse liabilityen
dc.subjectcigarsen
dc.subjectflavoren
dc.subjectprotocolen
dc.subjectregulatory scienceen
dc.subjecttobaccoen
dc.subject1103 Clinical Sciencesen
dc.subject1117 Public Health and Health Servicesen
dc.subject1199 Other Medical and Health Sciencesen
dc.subject.meshSalivaen
dc.subject.meshHumansen
dc.subject.meshNicotineen
dc.subject.meshGanglionic Stimulantsen
dc.subject.meshFlavoring Agentsen
dc.subject.meshAdolescenten
dc.subject.meshAdulten
dc.subject.meshClinical Trials as Topicen
dc.subject.meshYoung Adulten
dc.subject.meshSurveys and Questionnairesen
dc.subject.meshCigar Smokingen
dc.titleTriangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocolen
dc.title.serialBMJ Openen
dc.typeArticle - Refereeden
dc.type.dcmitypeTexten
dc.type.otherArticleen
dc.type.otherJournalen
pubs.organisational-group/Virginia Techen
pubs.organisational-group/Virginia Tech/University Research Institutesen
pubs.organisational-group/Virginia Tech/University Research Institutes/Fralin Life Sciencesen
pubs.organisational-group/Virginia Tech/University Research Institutes/Virginia Tech Carilion Research Instituteen
pubs.organisational-group/Virginia Tech/Faculty of Health Sciencesen
pubs.organisational-group/Virginia Tech/All T&R Facultyen
pubs.organisational-group/Virginia Tech/University Research Institutes/Fralin Life Sciences/Durelle Scotten
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