- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795997
Tobacco/Nicotine Purchase Patterns Across SES (AIM2)
ETM Taxes: The Impact of Innovative Tax Proposals on Purchase Patterns Across SES
Study Overview
Status
Intervention / Treatment
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:
- 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.
smoking-related assessments
- timeline follow back, to assess previous month recent smoking, e-cigarette use and consumption of nicotine products, and to determine ETM budget
- tobacco use history, exposure and preferences questions;
- the Fagerstrom Test of Nicotine Dependence for cigarettes and the Heaviness of Smoking Index for e-cigarettes to assess dependence.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: Jeff Stein, PhD, Virginia Polytechnic Institute and State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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