Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

Mark J Rzeszutek, PhD

Status: Completed

Conditions: Alcohol Use; E-cigarette Use; Cigarette Use

Treatments: Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks; Behavioral: Experimental Tobacco Marketplace

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07010601

5U54DA058256-02 (U.S. NIH Grant/Contract)

5U54DA058256-02 Pilot: #2345

Details and patient eligibility

About

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.

Enrollment: 737 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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737 participants in 2 patient groups

Qualtrics and Experimental Tobacco Marketplace

Experimental group

Description:

Participants who report using cigarettes/e-cigarettes will complete a Qualtrics survey consisting of various decision-making tasks, novel hypothetical nicotine product demand tasks, and Experimental Tobacco Marketplace scenarios (ETM). There will be three total ETM scenarios, cigarette adjusting price, e-cigarette adjusting price, and both e-cigarette and cigarette adjusting price.

Treatment:

Behavioral: Experimental Tobacco Marketplace

Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks

Qualtrics Only

Experimental group

Description:

Participants who do not report using cigarettes/e-cigarettes will complete will complete a Qualtrics survey consisting of various decision-making tasks, and novel hypothetical nicotine product demand tasks

Treatment:

Behavioral: Hypothetical Novel Nicotine Product Purchase Tasks