Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016, United States
Location contact
Roberta Freitas Lemos, Ph.D.
CONTACT
Roberta Freitas Lemos, Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07042373
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.
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
Roanoke, Virginia, 24016, United States
Roberta Freitas Lemos, Ph.D.
CONTACT
Roberta Freitas Lemos, Ph.D.
PRINCIPAL_INVESTIGATOR
In this study, the investigators will experimentally examine the impact of abuse-liability taxes on tobacco product purchases and ultimately tobacco dependence.
The investigators hypothesize that (1) the three abuse-liability tax proposals (product category score; product category rank; product tiers) will decrease purchasing of products with the highest abuse liability; and (2) increase purchasing of products with lower abuse liability (substitution) compared to control. Moreover, (3) the tax rate based on product category score will lead to the greatest substitution, because it is most reflective of abuse liability differences.
In a within-subject design, cigarette smokers stratified by age will complete one control trial and three ETM conditions representing the three tax rates based on abuse liability. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing and substitution are affected.
The study will consist of two in-lab visits and one phone call visit: 1) a consent and assessments session 2) an ETM session, and a 3) follow-up phone-call session approximately 7 days after session 2. Session 1 and 2 will be separated by an at home product sampling phase.
For the at home sampling period, participants will be shown a menu of the products available for purchase in the ETM. Participants will choose one product from each category, to sample at home, before the next session (approximately 4 days later). Participants will receive instructions to use the products over the next four days. Participants will complete a product evaluation scale for each product. Participants will be asked if they sampled each product as instructed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the control condition, participants will purchase tobacco/nicotine products in the ETM. Cigarettes will increase in price across trials.
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%.
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.
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%.
Time frame: Day 1
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).
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Contact information is provided by the study sponsor or research team.
Virginia Polytechnic Institute and State University
Other
Innovative Policy: Effects of Tobacco Abuse Liability-dependent Taxes in the ETM
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