The Impact of Innovative Tax Proposals on Purchase Patterns

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: Market Price Condition (control); Behavioral: Tobacco Parity Tax Condition; Behavioral: Nicotine-Content Tax Condition; Behavioral: Harm-Reduction Tax Condition; Behavioral: Modified Risk Tobacco Product (MRTP) Tax Condition

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Freitas Lemos, Ph.D.; Phone Number: 5405262106; Email: rflemos@vtc.vt.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Cancer Research Institute
      • Contact: Christine Sheffer
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Fralin Biomedical Research Institute
      • Contact: Kirstin M Gatchalian; Email: kmgatch@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cigarette smokers - Tobacco Parity; Exclusive cigarette smokers will be recruited and will be exposed to the control condition and the Tobacco Parity Tax Condition described in the intervention section.	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.; Behavioral: 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.
Experimental: Cigarette smokers - Nicotine-Content; Exclusive cigarette smokers will be recruited and will be exposed to the control condition and the Nicotine-Content Tax Condition described in the intervention section.	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.; Behavioral: 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.
Experimental: Cigarette smokers - Harm-Reduction; Exclusive cigarette smokers will be recruited and will be exposed to the control condition and the Harm-ReductionTax Condition described in the intervention section.	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.; Behavioral: 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.
Experimental: Cigarette smokers - Modified Risk Tobacco Products (MRTP); Exclusive cigarette smokers will be recruited and will be exposed to the control condition and the MRTP Tax Condition described in the intervention section.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: VT IRB # 22-433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team will share de-identified data upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No