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Clinical Trial Summary

This study will examine perceptions and smoking behavior of menthol and non-menthol very low nicotine cigarettes in young adult smokers. The aims are to examine perceptions and smoking behavior in the laboratory and in the natural environment. A separate sub-sample of men and women who identify as LGBTQ2S+ will also be recruited.


Clinical Trial Description

This proposal includes three different aspects of assessment for menthol smoking young adults. The laboratory phase includes three separate sessions of laboratory smoking through a machine designed to measure puff behavior; the EMA phase includes 21 days of monitoring smoking behavior and attitudes related to smoking when smoking one's usual brand cigarette, the assigned menthol low nicotine cigarette, and the assigned non-menthol low nicotine cigarette in the participant's natural environment. The order of administration of smoking menthol and non-menthol VLNC will be counterbalanced. There will be a 7-day wash-out period between each 7-day period of using low nicotine cigarettes. The final phase includes a virtual marketplace where participants can purchase and use the research cigarettes in the context of other available tobacco products on the market, or purchase no tobacco products at all. There will be a final assessment, over the phone or in-person, 30-days after the final study visit (at week 8), to assess tobacco use behavior and attitudes about tobacco use. Participants will be enrolled for approximately 9 weeks. Week 1 will consist of smoking one's usual brand of cigarette in the laboratory and then in their home environment for 7-days. Week 2 will consist of smoking the first very low nicotine cigarette in the home environment for 7 days and then in the laboratory. Week three will consist of a 7-day wash-out period where participants can smoke their usual brand again, as they normally would. Week 4 will consist of smoking the second very low nicotine cigarette at home for 7 days and then in the laboratory. Week 5 will consist of returning to the laboratory for a final study visit and complete a hypothetical experimental tobacco marketplace. One month (4 weeks) after the final study visit (week 9), participants will complete a 30-day follow-up of cigarette smoking and other tobacco use behavior. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04340947
Study type Interventional
Source University of Oklahoma
Contact Project Coordinator
Phone 405-271-7759
Email MyHealth@ouhsc.edu
Status Recruiting
Phase N/A
Start date August 1, 2021
Completion date December 31, 2024

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