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

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Cigarette Smoking; Nicotine Vaping

Treatments: Other: Nicotine vaping products at 2x market price; Other: Nicotine pouch products at 1/2 market price.; Other: Heated tobacco products at 1/2 market price.; Other: Nicotine pouch products at 2x market price.; Other: Nicotine vaping products at 1/2 market price; Other: All nicotine/ tobacco products at market price; Other: Heated tobacco products at 2x market price.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05177848

5P01CA200512 (U.S. NIH Grant/Contract)

IRB #21-1046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exclusive cigarette smokers

Experimental group

Description:

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

Treatment:

Other: Heated tobacco products at 2x market price.

Other: All nicotine/ tobacco products at market price

Other: Nicotine vaping products at 1/2 market price

Other: Nicotine pouch products at 2x market price.

Other: Heated tobacco products at 1/2 market price.

Other: Nicotine pouch products at 1/2 market price.

Other: Nicotine vaping products at 2x market price

Dual cigarette/ nicotine vaping product users

Experimental group

Description:

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.

Treatment:

Other: Heated tobacco products at 2x market price.

Other: All nicotine/ tobacco products at market price

Other: Nicotine vaping products at 1/2 market price

Other: Nicotine pouch products at 2x market price.

Other: Heated tobacco products at 1/2 market price.

Other: Nicotine pouch products at 1/2 market price.

Other: Nicotine vaping products at 2x market price