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Completed

NCT Number: NCT06456671

Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

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.

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Key information

Conditions

Cigarette Smoking Behavior Nicotine Vaping Smoking Tobacco Smoking Tobacco Use Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

All nicotine/ tobacco products at market price

Other

Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.

Nicotine vaping products at 1/2 market price

Other

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.

Heated tobacco products at 1/2 market price.

Other

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.

Nicotine pouch products at 1/2 market price.

Other

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.

Primary outcomes

  1. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price

    Proportion of the budget spent on cigarettes

Secondary outcomes

  1. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price Data are reported as the number of puffs purchased at each condition and cigarette trial price.

  2. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price Data is reported as the quantity purchased of HTP sticks at each condition and cigarette trial price.

  3. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price

    Data are reported as the quantity of nicotine pouches purchased for each condition and cigarette trial price.

  4. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price Data are reported as the quantity of NRT gums/lozenges purchased at each condition and cigarette trial price.

  5. 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

    • 0.5x market price
    • 1.0x market price (reference)
    • 2.0x market price
    • 4.0x market price
    • 8.0x market price

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

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MUSC-R 3a

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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