Clinical Research Directory

Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.

Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 4-week experiment.

DoubleTake: Effect of Message Exposure Via a Discrete Choice Experiment With Eye-Tracking on Quit Attempts Among Adults Who Smoke Menthol Cigarettes

\<p\>The goal of this clinical trial is to learn how exposure to anti-smoking social media messages affects quitting-related behaviors. Eligible participants will be adults aged 21 or older who have used menthol cigarettes on at least 4 days during the past 30 days.\</p\> \<br\> \<p\>The main question this study aims to answer is: Does exposure to anti-smoking messages (in the context of a discrete choice experiment \[DCE\] with eye-tracking study) increase quitting-related behaviors over the following 2 weeks?\</p\> \<br\> \<p\>Participants will be randomly assigned to view the messages either immediately or after a 2-week waiting period, allowing researchers to compare quitting-related behaviors between the two groups. The primary outcome is whether participants report making a quit attempt in the 2 weeks following randomization.\</p\> \<br\> \<p\>Participants will:\</p\> \<ul\> \<li\>Complete eligibility screening and baseline questions about demographics and tobacco use.\</li\> \<li\>Be randomly assigned to view the messages immediately or after a 2-week waiting period.\</li\> \<li\>Attend a 1-hour in-person study visit at Georgia State University or the University of California, Santa Barbara.\</li\> \<li\>View 64 anti-smoking social media messages presented in 16 choice sets while their eye movements and pupil dilation are measured using a screen-based eye-tracking device.\</li\> \<li\>Select which messages most attract their attention, which they would be most likely to share, and which would most motivate them to quit smoking.\</li\> \<li\>Complete questions about quitting-related behaviors either during the study visit (waitlist control condition) or through an online questionnaire 2 weeks later (immediate condition).\</li\> \</ul\>

Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace

The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.

Communicating About Nicotine Reduction in Cigarettes

The goal of this clinical trial is to learn how a messaging campaign about reduced nicotine cigarettes and policy, combined with the use of very low nicotine cigarettes (VLNCs), affects smoking behavior and attitudes among adult smokers. The study also aims to assess the efficacy of the messages in different populations, including smokers with past-month serious psychological distress (SPD), low socioeconomic status (SES), and those in neither category. The primary hypothesis is: exposure to messages in combination with VLNC use will lead to less cigarettes use compared to VLNCs without messages. Researchers will compare: The effects of receiving VLNCs with messages (treatment group) to receiving VLNCs without messages (control group). Participants will: Complete a baseline survey and be randomly assigned to one of two groups: treatment (VLNCs + messages) or control (VLNCs only). Attend weekly study visits for surveys, breath samples, and receive supply of VLNCs , either with or without the messaging campaign. Complete brief daily surveys through text messages.