Clinical trial NCT07010601: Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use
Official title: U54 Pilot: Comparing Tobacco Product Susceptibility and Product Substitution by Relative Rurality and Alcohol Use
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Use
E-cigarette Use
Cigarette Use
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-08
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A high priority research area for the Federal 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.


Eligibility criteria: Cigarette/E-Cigarette Users

Inclusion Criteria:

* 21 years of age or older
* Smoke cigarettes or use e-cigarettes 25 or more days a month

Cigarette/E-Cigarette Non-Users

Inclusion Criteria:

* 21 years of age or older
* Do not report using an e-cigarette or cigarette in the past month

Risky Alcohol Users

Inclusion Criteria:

* 21 years of age or older
* A score of 8 or higher on the Alcohol Use Disorder Identification Test

Non-Risky Alcohol Users

Inclusion Criteria:

* 21 years of age or older
* A score of 7 or lower on the Alcohol Use Disorder Identification Test

All groups

Inclusion Criteria:

* Located in the USA
* At least 100 complete studies on Prolific

Exclusion Critera:

* Failing attention checks during the screener

Primary outcomes:
measure: Demand Intensity and Price Sensitivity for Hypothetical Nicotine Products
timeFrame: Assessed at study week 0
measure: Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace
timeFrame: Assessed at study week 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: