Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

NCT ID: NCT07010601

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 737 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2025-08-20

Brief Summary

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.

Conditions

Alcohol Use; E-cigarette Use; Cigarette Use

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Qualtrics and Experimental Tobacco Marketplace

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.

Group Type: EXPERIMENTAL

Experimental Tobacco Marketplace

Intervention Type: BEHAVIORAL

This study will have three different scenarios in the Experimental Tobacco Marketplace (ETM) for participants who reported being cigarette and/or e-cigarette users. These will consist of hypothetical purchase scenarios where a variety of different tobacco products are available to purchase. The three ETM scenarios will be adjusting price cigarettes, adjusting price e-cigarettes, and both adjusting price cigarettes and e-cigarettes.

Hypothetical Novel Nicotine Product Purchase Tasks

Intervention Type: BEHAVIORAL

This study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points.

Qualtrics Only

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

Group Type: EXPERIMENTAL

Hypothetical Novel Nicotine Product Purchase Tasks

Intervention Type: BEHAVIORAL

This study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points.

Interventions

Experimental Tobacco Marketplace

This study will have three different scenarios in the Experimental Tobacco Marketplace (ETM) for participants who reported being cigarette and/or e-cigarette users. These will consist of hypothetical purchase scenarios where a variety of different tobacco products are available to purchase. The three ETM scenarios will be adjusting price cigarettes, adjusting price e-cigarettes, and both adjusting price cigarettes and e-cigarettes.

Intervention Type: BEHAVIORAL

Hypothetical Novel Nicotine Product Purchase Tasks

This study will have a set of hypothetical demand tasks for novel nicotine products. These tasks consist of different novel hypothetical products (combusted, oral, and vaporized) of differing nicotine content (high and low), and different flavors (preferred alcoholic flavor, no characterizing flavor) where likelihood to try is assessed at a variety of price points.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Risky Alcohol Users

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

Non-Risky Alcohol Users

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

All groups

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

Exclusion Critera:

• Failing attention checks during the screener

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mark J Rzeszutek, PhD

OTHER

Sponsor Role: lead

Responsible Party

Mark J Rzeszutek, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5U54DA058256-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5U54DA058256-02 Pilot: #2345

Identifier Type: -

Identifier Source: org_study_id