What is the purpose of the study?
This study will examine how nicotine concentration and flavor of e-liquids affects mood and responses to electronic cigarettes. The Food and Drug Administration (FDA) regulates tobacco products including electronic cigarettes, and can require product standards that may reduce harm from tobacco products, such as having rules about how much nicotine or which flavors are available to decrease youth uptake.
The study looks at differences across four nicotine/flavor combinations. The measures that we examine will evaluate how using the different nicotine/flavor combinations in an electronic cigarette affects mood and responses to the product, such as satisfaction, or taste, or use.
The electronic cigarettes and pods used in this study are JUUL brand that you can buy at the store. They include 3% and 5% nicotine salt weight by volume and Menthol and Virginia Tobacco flavors.
How long with the research last?
We expect that you will be in this research study for two to three weeks. During this time you will attend one screening session and five visits that will last approximately one hour each at the Delaware Clinic Research Unit on the University of Minnesota Campus. Visits will be at least 48 hours apart. You will also take home a JUUL device and four pods to use for 10 days.
What will I be doing in the study?
You will be asked to attend five lab sessions: one where you will use your own cigarette and four where you will sample an electronic cigarette. You will not be able to smoke any cigarettes or other combustible products (e.g. cigars, marijuana) prior to each visit. During the visits, you will complete questionnaires asking you about your mood and your response to the product. You will also have a breath test for carbon monoxide and vital signs will be taken. We will collect one urine sample from you. Following lab sessions, you will then take home all four nicotine/flavor combinations home to sample for three days, after which you will choose one pod to continue to use for another seven days. You will complete short daily questionnaires about your electronic cigarette and cigarette use during this period.
Due to COVID-19, procedures will be a mix of remote (telehealth), curbside (outside the clinic), and in-clinic. Remote sessions will occur over Zoom and will include questionnaires. Curbside visits will consist of dropping off or picking up products for the study. In-clinic visits will include physiological measurements and product sampling. Should more strict COVID-19 safety procedures be required, product sampling will be moved to an online session.
For any in-clinic visits, you will be required to wear a mask, and non-curbside visits will be completed in a room that has a smaller room inside it (with a glass window and door between) for safety. Should safety demand it, visits will be done virtually using video conferencing, and participants will need a secluded space of their own without distractions or interruptions for these sessions.
Will I be compensated?
If you agree to take part in this research study, you will be paid $20 for the screening visit, $20 for each of the five lab visits, $10 for each daily questionnaire received for the 3 sampling and 7 use days, plus a $100 for completing the study and following study procedures, for a total of $320 possible.
What should I do if I am interested?
If you would like to find out if you qualify for this study, call the University of Minnesota Tobacco Research Programs at (612) 393-8967.