Effects of Tobacco Abuse Liability-dependent Taxes in the ETM

NCT07042373 | Not Yet Recruiting

• 2 other identifiers: VT IRB # 23-7295K01CA279490-02
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution. The investigators will use a repeated-measures (within subject) analysis of variance (ANOVA) to test if there are differences between conditions (i.e., tax proposals) independently for each product. The models will include study design parameters for order effects to account for counterbalancing the tax conditions in the ETM. Each tax condition will be compared to the control. All distributional assumptions will be checked prior to analyses and the appropriate transformations will be employed, if needed. For each significant result from the omnibus test, the investigators will perform planned contrasts to test the proposed hypotheses previously described. Note that the omnibus test can result in a significant finding while the contrasts of interest may be non-significant. In this case, the investigators will only report the results from the planned contrasts. Additional analyses might be conducted.

Conditions

Cigarette Smoking Behavior

Keywords

Cigarettes; Experimental Tobacco Marketplace; Abuse Liability

Outcome Measures

Primary Outcomes (4)

• Cigarette Demand Intensity

  Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 \* 10\^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Intensity will be reported, which represents the estimated mg of nicotine purchased when cigarettes are free (price = 0).

  Day 1

• Cigarette Demand Elasticity

  Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand will be estimated using the exponential equation: Q = Q0 \* 10\^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Elasticity will be reported, which represents the sensitivity of purchasing to changes in cigarette price.

  Day 1

• Nicotine/Tobacco Products Substitution Slope

  Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Slope of price-constant products will be reported, which represents the change in mg of nicotine purchased of price-constant products divided by the change in cigarette price.

  Day 1

• Nicotine/Tobacco Products Substitution Intercept

  Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM), where nicotine/tobacco prices will increase accordingly with the condition. The quantity of products purchased in the ETM will be converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data will reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Y-intercept of price-constant products will be reported.

  Day 1

Study Arms (1)

Cigarette smokers

EXPERIMENTAL

In a within-subject design, cigarette smokers, stratified by age, will purchase tobacco products under three tax rate conditions based on abuse liability, that is taxes based on: (1) product category score (i.e. score ranging from 0-1 based on abuse liability effect sizes); (2) product category rank (i.e. position of a product relative to all others; e.g. 1st, 5th); and (3) product tiers (i.e. low-, medium-, high abuse liability), as well as a control. In the ETM, the effects of these interventions will be examined on cigarette demand and other products substitution.

Behavioral: Control; Behavioral: Product Category Score; Behavioral: Product Category Rank; Behavioral: Product Tiers

Interventions

Control BEHAVIORAL

In the control condition, participants will purchase tobacco/nicotine products in the ETM. Cigarettes will increase in price across trials.

Cigarette smokers

Product Category Score BEHAVIORAL

In the product category score condition, participants will purchase tobacco/nicotine products in the ETM where the percentage of taxes applied to each product category will be distributed between 0% and 100% proportional to their abuse liability score. Abuse liability scores will be scaled such that the product category with the highest abuse liability will be taxed at 100%.

Cigarette smokers

Product Category Rank BEHAVIORAL

In the product category rank condition, participants will purchase tobacco/nicotine products in the ETM where the tax percentage applied to each product category will be determined by the number of categories and their position in the ranking. The product category with the highest abuse liability will be taxed at 100%; the product with the lowest abuse liability will be taxed at 0%. All other tax rates will be equally spaced across other products based on ranking.

Cigarette smokers

Product Tiers BEHAVIORAL

In the product tiers condition, participants will purchase tobacco/nicotine products in the ETM where tobacco products will be placed in tax tiers to simplify the existing complex tobacco tax system. The investigators will use three tax tiers (i.e., high tax, medium tax, and no tax), as adopted by four states. Products will be placed into tiers depending on their average score (i.e. no tax: \< 0.33, medium tax: 0.33-0.66, and high tax: \>0.66). Products in the high tax tier will be taxed at 100% and products in the medium tax tier will be taxed at 50%.

Cigarette smokers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Be at least 21 years of age or older
• Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
• Smoke at least 10 cigarettes daily
• Use other tobacco products less than weekly

You may not qualify if:

• Have uncontrolled physical or mental health conditions
• Use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days
• Report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days
• If they are pregnant or lactating
• Have plans to move out of the area during the experiment

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (5)

• Chaloupka FJ, Grossman M, Bickel WK, Saffer H. The Economic Analysis of Substance Use and Abuse: An Integration of Econometric and Behavioral Economic Research. 1999 Jan 1

  BACKGROUND

• Freitas-Lemos R, Keith DR, Tegge AN, Stein JS, Cummings KM, Bickel WK. Estimating the Impact of Tobacco Parity and Harm Reduction Tax Proposals Using the Experimental Tobacco Marketplace. Int J Environ Res Public Health. 2021 Jul 23;18(15):7835. doi: 10.3390/ijerph18157835.

  PMID: 34360124 BACKGROUND

• Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20.

  PMID: 28634710 BACKGROUND

• Shakhnovich V. It's Time to Reverse our Thinking: The Reverse Translation Research Paradigm. Clin Transl Sci. 2018 Mar;11(2):98-99. doi: 10.1111/cts.12538. Epub 2018 Feb 9. No abstract available.

  PMID: 29423973 BACKGROUND

• Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.

  PMID: 31350894 BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Roberta Freitas Lemos, Ph.D.

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Freitas Lemos, Ph.D.

CONTACT

5405262106; rflemos@vtc.vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 29, 2025
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The research community will have access to data upon publication of this study, consistent with the NDA guidelines. NDA will make decisions about how long to preserve the data.
• Access Criteria: Researchers will use the standard processes at NDA to request access to the data. The NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.

Locations

US (1)