NCT07142668

Brief Summary

This study will investigate the effects of normal-nicotine versus low-nicotine cigarette availability in the context of four tax proposals (Tobacco Parity, Nicotine-Content, Harm-Reduction, and Modified Risk Tobacco Product-based taxes) on tobacco product purchasing patterns in a virtual marketplace.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress83%
Aug 2025Jul 2026

First Submitted

Initial submission to the registry

August 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 7, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

Experimental Tobacco Marketplace

Outcome Measures

Primary Outcomes (1)

  • Percent of Budget Allocated to Products from each Tax Tier

    The investigators will measure the percent of each participant's study budget spent on products from each of the three tax tiers (high-, medium, and no-tax).

    Day 1

Secondary Outcomes (1)

  • Quantity of Products Purchased from each Tax Tier

    Day 1

Study Arms (4)

Tobacco Parity

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the 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.

Behavioral: Tobacco Parity Tax - Normal Nicotine Cigarettes AvailableBehavioral: Tobacco Parity Tax - Normal Nicotine Cigarettes Not Available

Nicotine Content

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the Nicotine-Content Tax Condition. 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.

Behavioral: Nicotine Content Tax - Normal Nicotine Cigarettes AvailableBehavioral: Nicotine Content Tax - Normal Nicotine Cigarettes Not Available

Harm Reduction

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the 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.

Behavioral: Harm Reduction Tax - Normal Nicotine Cigarettes AvailableBehavioral: Harm Reduction Tax - Normal Nicotine Cigarettes Not Available

Modified Risk Tobacco Products (MRTP)

EXPERIMENTAL

Exclusive cigarette smokers will be recruited and will be exposed to two control trials and the Modified Risk Tobacco Products 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.

Behavioral: Modified Risk Tobacco Product Tax - Normal Nicotine Cigarettes AvailableBehavioral: Modified Risk Tobacco Product Tax - Normal Nicotine Cigarettes Not Available

Interventions

In the Harm Reduction Tax Condition, tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. 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. The participant's preferred normal-nicotine content cigarettes are available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Harm Reduction

In the Harm Reduction Tax Condition, tobacco products in the Experimental Tobacco Marketplace are placed into three tax tiers: high-, medium-, and no-tax. 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. The participant's preferred normal-nicotine content cigarettes are NOT available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Harm Reduction

In the Modified Risk Tobacco Products 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. The participant's preferred normal-nicotine content cigarettes are available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Modified Risk Tobacco Products (MRTP)

In the Modified Risk Tobacco Products 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. The participant's preferred normal-nicotine content cigarettes are NOT available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Modified Risk Tobacco Products (MRTP)

In the Nicotine-Content Tax Condition, 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. The participant's preferred normal-nicotine content cigarettes are available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Nicotine Content

In the Nicotine-Content Tax Condition, 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. The participant's preferred normal-nicotine content cigarettes are NOT available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Nicotine Content

In the 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. The participant's preferred normal-nicotine content cigarettes are available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Tobacco Parity

In the 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. The participant's preferred normal-nicotine content cigarettes are NOT available in the marketplace. Participants complete two trials with all products offered at market price, and five trials with prices for each product increasing proportionally to tax tier.

Tobacco Parity

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

RECRUITING

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking

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

Central Study Contacts

Kirstin Gatchalian

CONTACT

Madeleine G Mason, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will complete two control trials and one Experimental Marketplace condition, representing one of the four tax proposals. Within each tax policy group, each participant will complete five purchase scenarios in which conventional cigarettes are available and five in which conventional cigarettes are not available. In each condition, taxes will be increased proportionally across five trials to examine how cigarette purchasing and product substitution are affected.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 27, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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

Locations