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

Study Overview
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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.

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

Conditions
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Cigarette Smoking, Nicotine Vaping

Intervention / Treatment
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* 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.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exclusive cigarette smokers<br>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<br>* Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.<br>Other: Nicotine vaping products at 1/2 market price<br>* 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.<br>Other: Nicotine vaping products at 2x market price<br>* 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.<br>Other: Heated tobacco products at 1/2 market price.<br>* 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.<br>Other: Heated tobacco products at 2x market price.<br>* 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.<br>Other: Nicotine pouch products at 1/2 market price.<br>* 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.<br>Other: Nicotine pouch products at 2x market price.<br>* 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.<br>|
| Experimental: Dual cigarette/ nicotine vaping product users<br>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<br>* Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.<br>Other: Nicotine vaping products at 1/2 market price<br>* 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.<br>Other: Nicotine vaping products at 2x market price<br>* 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.<br>Other: Heated tobacco products at 1/2 market price.<br>* 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.<br>Other: Heated tobacco products at 2x market price.<br>* 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.<br>Other: Nicotine pouch products at 1/2 market price.<br>* 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.<br>Other: Nicotine pouch products at 2x market price.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine/tobacco products substitution | 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 | 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 |