Tobacco/Nicotine Purchase Patterns Across SES (AIM2)

May 15, 2025 updated by: Jeffrey Stein, Virginia Polytechnic Institute and State University

ETM Taxes: The Impact of Innovative Tax Proposals on Purchase Patterns Across SES

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

663

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exclusive Cigarette Smokers
Exclusive cigarette smokers will be recruited and will be exposed to all of the tax conditions described in the intervention section.
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 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.
Experimental: Exclusive Cigarette Smokers-Control Condition
Exclusive cigarette smokers will be recruited and will be exposed to the control condition described in the intervention section.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tobacco Product Purchasing
Time Frame: 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
Participants will make hypothetical purchases of tobacco products to use throughout the next 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeff Stein, PhD, Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • VT IRB 24-1228
  • 5R01CA266966 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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