Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study (MUSC-R 3a)

March 31, 2026 updated by: Roberta Freitas-Lemos, Virginia Polytechnic Institute and State University

Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • From CA, US, or EN
  • At least 21 years old
  • Smoking daily
  • Smoking mostly or about equal amounts of factory-made cigarettes
  • Does not currently vape (for exclusive smokers only)
  • Vapes Daily (for dual users only)

Exclusion Criteria:

  • There will be no additional exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exclusive cigarette smokers
Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Other: All nicotine/ tobacco products at market price
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Other: Nicotine vaping products at 1/2 market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Other: Heated tobacco products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Other: Nicotine pouch products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Experimental: Dual cigarette/ nicotine vaping product users
Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Other: All nicotine/ tobacco products at market price
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Other: Nicotine vaping products at 1/2 market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Other: Heated tobacco products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Other: Nicotine pouch products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Budget Spent - CIGARETTES
Time Frame: 1 day

Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (nicotine vaping products, heated tobacco products, nicotine pouch products) prices was assessed.

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price

Proportion of the budget spent on cigarettes
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alternative Product Consumption - E-CIGARETTES
Time Frame: 1 day

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price Data are reported as the number of puffs purchased at each condition and cigarette trial price.
1 day
Alternative Product Consumption - HTP
Time Frame: 1 day

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price Data is reported as the quantity purchased of HTP sticks at each condition and cigarette trial price.
1 day
Alternative Product Consumption - Nicotine Pouches
Time Frame: 1 day

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price

Data are reported as the quantity of nicotine pouches purchased for each condition and cigarette trial price.
1 day
Alternative Product Consumption - Nicotine Replacement Therapy
Time Frame: 1 day

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price Data are reported as the quantity of NRT gums/lozenges purchased at each condition and cigarette trial price.
1 day
Alternative Product Consumption - Oral Tobacco Products
Time Frame: 1 day

Participants completed the ETM task under four within-subject conditions:

Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price

Within each condition, cigarette prices ascended across 5 trials:

Trial Cigarette Price Multiplier

  1. 0.5x market price
  2. 1.0x market price (reference)
  3. 2.0x market price
  4. 4.0x market price
  5. 8.0x market price

Data are reported as the quantity of SNUS/DIP (oral tobacco products) purchased for each condition and cigarette trial price.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

Medical University of South Carolina
National Cancer Institute (NCI)
University of Waterloo

Investigators

  • Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Actual)

January 7, 2025

Study Completion (Actual)

January 7, 2025

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #24-520
  • 5P01CA200512 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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