Tobacco Product Susceptibility and Substitutability by Rurality and Alcohol Use

Mark J Rzeszutek, PhD737 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

737

Conditions

Alcohol Use

Interventions

Experimental Tobacco MarketplaceBEHAVIORAL

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 TasksBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Demand Intensity and Price Sensitivity for Hypothetical Nicotine Products

Likelihood to purchase and consume hypothetical nicotine products and sensitivity to cost of different product categories, flavors, and nicotine combinations will be assessed in all groups. Hypothetical demand will be assessed using non-linear mixed-effects modeling to obtain estimates of demand intensity and price sensitivity for these hypothetical products. Higher intensity and lower price sensitivity are indicators for higher subjective value and likelihood to try these novel products.

Time frame: Assessed at study week 0

Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace

Cigarette and e-cigarette users will complete different experimental tobacco marketplace scenarios. Alternative product purchasing (substitution) for different nicotine products as a function of increasing price of cigarettes/e-cigarettes will be measured with non-linear mixed-effects cross-commodity demand equations that determine the magnitude and direction of product substitution as a function of price increases of cigarettes and/or e-cigarettes. A higher magnitude indicates a larger change in product purchasing as a function of the ascending price item, where direction determines if the commodity was a complement to or substitute of the ascending price item(s). In the case of failures of non-linear model fitting, linear models will be used to determine product substitution based on intercept (initial purchasing) and slope (degree of substitution).