The Impact of Innovative Tax Proposals on Purchase Patterns

Cigarette Smoking Clinical Trial

Official title:

ETM Taxes Study 1: The Impact of Innovative Tax Proposals on Purchase Patterns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370313
• Other study ID #: VT IRB # 22-433
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: Roberta Freitas Lemos, Ph.D.
• Phone: 5405262106
• Email: rflemos[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of four tax proposals (i.e. Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-related taxes) on tobacco product purchasing patterns.

Description:

This study experimentally examines the effects of largely untried integrated tax proposals. Four tax proposals will be modeled: Tobacco Parity, Nicotine-Content, Harm-Reduction, and MRTP. Tobacco products are placed into three tax tiers: high-, medium-, and no-tax, according to the goals of each proposal. In a within-between subject design (tax proposals between subjects; control condition within subject), cigarette smokers will complete two conditions in the Experimental Tobacco Marketplace, representing one control condition and one of the four tax proposals. Within each condition, taxes will be increased proportionally across 6 trials (relative to tax tier) to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• provide informed consent
• provide a breath carbon monoxide sample = 8 ppm,
• be at least 21 years of age (the legal age to purchase tobacco),
• smoke at least 5 cigarettes daily, and
• use other tobacco products less than weekly.

Exclusion Criteria:

• report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
• 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,
• be pregnant or lactating, or
• have plans to move out of the area during the experiment.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Market Price Condition (control)
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Cigarette taxes increased across trials at the same magnitudes used in the tax conditions.
• Tobacco Parity Tax Condition
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all tobacco products are placed in the high-tax tier while products that do not contain tobacco (e.g., herbal cigarettes and nicotine-free ENDS) are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier.
• Nicotine-Content Tax Condition
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, products with greater than 3 mg nicotine per single unit are placed in the high-tax tier, products with 0.6-3.0 mg/unit in the medium-tax tier, and those with 0.5 mg/unit or less in the no-tax tier.
• Harm-Reduction Tax Condition
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all combustible products with high abuse liability are placed in the high-tax tier. All non-combustible products or combustible products with low abuse liability are placed in the medium-tax tier. Nicotine Replacement Therapy products are placed in the no-tax tier.
• Modified Risk Tobacco Product (MRTP) Tax Condition
Tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. In this condition, all non-MRTP tobacco products are placed in the high-tax tier, MRTPs are placed in the medium-tax tier, and Nicotine Replacement Therapy products are placed in the no-tax tier.

Locations

Country	Name	City	State
United States	Roswell Cancer Research Institute	Buffalo	New York
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of Tobacco Products Purchased in the High-Tax Tier - Product demand (intensity and elasticity)	Purchasing of high-tax tier products in the ETM conditions will be fit to a commonly used exponential demand model that quantifies the relationship between the multiplicative tax factor (e.g., 2 times base tax rate) and purchasing of high-tax tier products. This demand analysis (which assumes a negative association between price and purchasing) will be used in the high-tax tier products because participants will be conventional cigarette smokers and these products (when available) will always be in that tier. As such, we expect participants to defend their purchase of cigarettes in the high-tax tier under a variety of conditions. Demand estimates will be obtained for each participant in each tax proposal.	1 day
Primary	Quantity of Tobacco Products Purchased in the Medium- and No-tax tiers - Product substitution (intensity and slope)	Purchasing of medium- and no-tax products in the ETM conditions will be fit to ordinary least squares regression for each tax tier. This yields slope measures of each tax tier's product purchasing, wherein more positive slopes indicate greater substitution (i.e., greater increases in purchasing of substitutes as tax magnitudes increase). Ordinary least squares regression is used here to model purchasing in the medium- and no-tax tier because it is capable of measuring positive slopes, indicative of substitution, and distinguishing these tiers from those that do not show substitution. In the event this relationship is non-linear, we will consider other relevant models.	1 day
Primary	Poly-tobacco purchasing	To obtain a measure of poly-tobacco purchasing, entropy (H), a concept borrowed from information theory, will be used. Entropy is the average level of information in the variable outcomes. In this proposed use, entropy is minimized for a participant who only purchases one type of product (no inherent information) in a given trial. Entropy is maximized for participants that purchase equivalent quantities of all products in a given trial. Entropy permits us to differentiate between participants that purchase mostly cigarettes and a sampling quantity of all other products compared to participants who purchase equivalent quantities of all available products.	1 day