Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol
| Autor: | Cosima Hoetger, Mignonne C. Guy, Rose S Bono, Thokozeni Lipato, Rebecca C Lester, Andrew J. Barnes, Thomas Eissenberg, Warren K. Bickel, Catherine S J Wall, Caroline O. Cobb |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
PURCHASE TASK
DEMAND Cigar Smoking 030508 substance abuse tobacco 0302 clinical medicine Surveys and Questionnaires YOUNG-ADULTS Protocol Regulatory science 030212 general & internal medicine Young adult Clinical Trials as Topic General Medicine Institutional review board Ganglionic Stimulants 3. Good health abuse liability TRANSDERMAL NICOTINE regulatory science SMOKING 0305 other medical science Life Sciences & Biomedicine Behavioural economic Adult medicine.medical_specialty Nicotine Adolescent NICOTINE EXPOSURE TOBACCO PRODUCTS Within person UNITED-STATES 1117 Public Health and Health Services 03 medical and health sciences Young Adult Medicine General & Internal General & Internal Medicine medicine Abuse liability Humans EXPOSURE protocol Psychiatry Saliva Smoking and Tobacco Protocol (science) flavor business.industry CONSUMPTION 1103 Clinical Sciences Flavoring Agents cigars PUFF TOPOGRAPHY business 1199 Other Medical and Health Sciences |
| Zdroj: | BMJ Open |
| Popis: | IntroductionIn 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 analysesParticipants (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 disseminationThe 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.Trial registration numberNCT02937051. |
| Databáze: | OpenAIRE |
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