Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type

January 28, 2025 updated by: Roberta Freitas-Lemos, Virginia Polytechnic Institute and State University
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 and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Study Type

Interventional

Enrollment (Actual)

60

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provide informed consent
  • Be at least 21 years of age or older
  • Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
  • Stable tobacco use patterns for at least three months
  • Be willing to sample NVPs, HTPs, and NPPs
  • For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month)
  • For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system)

Exclusion Criteria:

  • Have plans to move out of the area
  • Have a serious or unstable physical or mental health condition
  • Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
  • Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the 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: Nicotine vaping products at 2x market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x 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: Heated tobacco products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x 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.
Other: Nicotine pouch products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x 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: Nicotine vaping products at 2x market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x 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: Heated tobacco products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x 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.
Other: Nicotine pouch products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x 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
Nicotine/Tobacco Products Substitution
Time Frame: 1 day

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

To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.
1 day
Cigarette Demand
Time Frame: 1 day

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

To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.
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)

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)

June 29, 2022

Primary Completion (Actual)

June 2, 2023

Study Completion (Actual)

June 7, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #21-1046
  • 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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