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

Not Applicable

Active, not recruiting

• Conditions: Nicotine Vaping; Cigarette Smoking
• Interventions: Other: All nicotine/ tobacco products at market price; Other: Nicotine vaping products at 1/2 market price; Other: Nicotine vaping products at 2x market price; Other: Heated tobacco products at 1/2 market price.; Other: Heated tobacco products at 2x market price.; Other: Nicotine pouch products at 1/2 market price.; Other: Nicotine pouch products at 2x market price.

• Registration Number: NCT05177848
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-05
• Study Start: 2022-06-29
• Primary Completion: 2023-08-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Study Completion: 2024-11-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exclusive cigarette smokers	Nicotine vaping products at 2x market price	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	Nicotine vaping products at 1/2 market price	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	Heated tobacco products at 1/2 market price.	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	Nicotine pouch products at 1/2 market price.	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	Heated tobacco products at 2x market price.	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	All nicotine/ tobacco products at market price	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Exclusive cigarette smokers	Nicotine pouch products at 2x market price.	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	All nicotine/ tobacco products at market price	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Nicotine vaping products at 1/2 market price	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Nicotine vaping products at 2x market price	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Heated tobacco products at 1/2 market price.	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Heated tobacco products at 2x market price.	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Nicotine pouch products at 1/2 market price.	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Nicotine pouch products at 2x market price.	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.

Primary Outcome Measures

Name	Time	Method
Nicotine/Tobacco Products Substitution	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.
Cigarette Demand	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.

Trial Locations

Locations (1)

Fralin Biomedical Research Institute; 🇺🇸 Roanoke, Virginia, United States