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

NCT ID: NCT05177848

Last Updated: 2025-01-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2023-06-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking Nicotine Vaping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exclusive cigarette smokers

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Group Type EXPERIMENTAL

All nicotine/ tobacco products at market price

Intervention Type 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

Intervention Type 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.

Nicotine vaping products at 2x market price

Intervention Type OTHER

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.

Heated tobacco products at 1/2 market price.

Intervention Type 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.

Heated tobacco products at 2x market price.

Intervention Type OTHER

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.

Nicotine pouch products at 1/2 market price.

Intervention Type 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 2x market price.

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

All nicotine/ tobacco products at market price

Intervention Type 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

Intervention Type 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.

Nicotine vaping products at 2x market price

Intervention Type OTHER

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.

Heated tobacco products at 1/2 market price.

Intervention Type 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.

Heated tobacco products at 2x market price.

Intervention Type OTHER

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.

Nicotine pouch products at 1/2 market price.

Intervention Type 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 2x market price.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Roberta Freitas-Lemos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warren K Bickel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fralin Biomedical Research Institute at VTC

Locations

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Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P01CA200512

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB #21-1046

Identifier Type: -

Identifier Source: org_study_id

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