NCT05370313

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

April 29, 2022

Last Update Submit

September 17, 2025

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Cigarette smokers - Sequence 1

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the four tax policy conditions in this sequence: Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction, Nicotine Content.

Behavioral: Market Price Condition (control)Behavioral: Tobacco Parity Tax ConditionBehavioral: Nicotine-Content Tax ConditionBehavioral: Harm-Reduction Tax ConditionBehavioral: Modified Risk Tobacco Product (MRTP) Tax Condition

Cigarette smokers - Sequence 2

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the four tax policy conditions in this sequence: Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products, Harm Reduction.

Behavioral: Market Price Condition (control)Behavioral: Tobacco Parity Tax ConditionBehavioral: Nicotine-Content Tax ConditionBehavioral: Harm-Reduction Tax ConditionBehavioral: Modified Risk Tobacco Product (MRTP) Tax Condition

Cigarette smokers - Sequence 3

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Modified Risk Tobacco Products, Harm Reduction, Nicotine Content, Tobacco Parity.

Behavioral: Market Price Condition (control)Behavioral: Tobacco Parity Tax ConditionBehavioral: Nicotine-Content Tax ConditionBehavioral: Harm-Reduction Tax ConditionBehavioral: Modified Risk Tobacco Product (MRTP) Tax Condition

Cigarette smokers - Sequence 4

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and each of the the four tax policy conditions in this sequence: Harm Reduction, Nicotine Content, Tobacco Parity, Modified Risk Tobacco Products.

Behavioral: Market Price Condition (control)Behavioral: Tobacco Parity Tax ConditionBehavioral: Nicotine-Content Tax ConditionBehavioral: Harm-Reduction Tax ConditionBehavioral: Modified Risk Tobacco Product (MRTP) Tax Condition

Interventions

Market Price Condition (control)BEHAVIORAL

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.

Cigarette smokers - Sequence 1Cigarette smokers - Sequence 2Cigarette smokers - Sequence 3Cigarette smokers - Sequence 4
Tobacco Parity Tax ConditionBEHAVIORAL

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.

Cigarette smokers - Sequence 1Cigarette smokers - Sequence 2Cigarette smokers - Sequence 3Cigarette smokers - Sequence 4
Nicotine-Content Tax ConditionBEHAVIORAL

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.

Cigarette smokers - Sequence 1Cigarette smokers - Sequence 2Cigarette smokers - Sequence 3Cigarette smokers - Sequence 4
Harm-Reduction Tax ConditionBEHAVIORAL

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.

Cigarette smokers - Sequence 1Cigarette smokers - Sequence 2Cigarette smokers - Sequence 3Cigarette smokers - Sequence 4
Modified Risk Tobacco Product (MRTP) Tax ConditionBEHAVIORAL

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.

Cigarette smokers - Sequence 1Cigarette smokers - Sequence 2Cigarette smokers - Sequence 3Cigarette smokers - Sequence 4

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 10 cigarettes daily, and
  • use other tobacco products less than weekly.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

metariboadenosine triphosphorous

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Jeff S Stein, Ph.D.

    Fralin Biomedical Research Institute at VTC

    PRINCIPAL INVESTIGATOR

  • Christine E Sheffer, Ph.D.

    Roswell Park Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will each complete two control trials and four Experimental Marketplace conditions, representing each of the four tax proposals. The order of tax proposal conditions will be determined randomly. Within each condition, taxes will be increased proportionally across 5 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 11, 2022

Study Start

April 11, 2023

Primary Completion

May 27, 2025

Study Completion

June 10, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

The study team will share de-identified data upon request.

Locations

US(2)