Clinical trial NCT06795997: Tobacco/Nicotine Purchase Patterns Across SES
Official title: ETM Taxes: The Impact of Innovative Tax Proposals on Purchase Patterns Across SES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Smoking, Non-Tobacco Products
Smoking, Cigarette
Keywords: Experimental Tobacco Marketplace
Tobacco Regulatory Policy
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-28
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within-subject design
Primary purpose: BASIC_SCIENCE

Brief summary: In a within-subject design, investigators will use the Experimental Tobacco Marketplace (ETM) to systematically impose 4 novel tobacco/nicotine tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) covering a broad range of tax magnitudes. Participants will complete one control trial and all conditions (tax proposals) in the ETM with 5 trials each. Analyses will model the quantity of the product purchased as a function of tax tier (i.e., high, medium, no tax) and examine poly-tobacco purchasing.

Detailed description: Although taxes have been studied in econometric and quasi-experimental studies, the ETM is the only experimental laboratory model that has examined the impact of taxes on purchasing behavior. In pilot data collected originally for the prior version of this grant's application, investigators examined the Tobacco Parity Tax and Harm-Reduction Tax among exclusive cigarette smokers (n=35) in an online hypothetical ETM. Briefly, each tax proposal had 3 tax tiers (see C.1 Implementation of Tax Proposals, for the rationale) in the ETM with a subset of products. Therein, the Tobacco Parity Tax decreased purchases from the highest tax tier (p\<0.001; f=0.49) and increased purchases of the no-tax tier (nicotine gum/lozenges were the most purchased; p\<0.001; f=0.36) as taxes increased.

Conversely, the Harm-Reduction Tax resulted in greater purchases from the middle tier as tax constraints increased (ENDS were the most purchased; p\<0.001; f=0.29). Moreover, the Harm-Reduction Tax elicited a greater substitution of medium-tiered products compared to the Tobacco Parity Tax (p\<0.001; f=0.15). In follow-up secondary analyses of this preliminary data, investigators stratified these tax proposal by SES and found the largest effect in the Harm-Reduction Tax with the low SES group exhibiting the highest substitution of medium-tax tier products compared to more affluent groups (ps\<0.001; f=0.16; Fig. 3). These results must be replicated with larger samples. In this study, investigators will ensure socioeconomic representation reflective of the US population. Given the robust effect of tax magnitude, investigators will also examine purchasing across a broad range of magnitudes to fully characterize each novel tax proposal-thereby discerning how smokers will defend their consumption or substitute with other products.

Participants will complete a one session study including consent and behavioral tasks (ETM and smoking-related assessments). A Qualtrics survey will administer:

1. the electronic informed consent; Participants will read through the informed consent and consent will be implied with submission of the assessment at the end of the survey.
2. smoking-related assessments

   1. timeline follow back, to assess previous month recent smoking, e-cigarette use and consumption of nicotine products, and to determine ETM budget
   2. tobacco use history, exposure and preferences questions;
   3. the Fagerstrom Test of Nicotine Dependence for cigarettes and the Heaviness of Smoking Index for e-cigarettes to assess dependence.
3. the ETM; Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days. Participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price: Tobacco Parity, Nicotine-Content, Harm- Reduction, and Modified Risk Tobacco Product-related taxes.

Eligibility criteria: Inclusion Criteria:

* provide informed consent
* be at least 21 years of age
* smoke at least 10 cigarettes daily and use other tobacco products less than weekly

Exclusion Criteria:

• pregnant or lactating

Primary outcomes:
measure: Tobacco Product Purchasing
timeFrame: During a one-session study, participants will complete a total of 21 purchasing trials each for 7 days' worth of products. They will be exposed to a control trial and 4 conditions with 5 trials each, where products will increase in price
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Jeff Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References: