Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study (MUSC-R 3a)

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Cigarette Smoking; Nicotine Vaping

Treatments: Other: All nicotine/ tobacco products at 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 1/2 market price

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06456671

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

IRB #24-520

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, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Enrollment: 443 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• From CA, US, or EN
• At least 21 years old
• Smoking daily
• Smoking mostly or about equal amounts of factory-made cigarettes
• Does not currently vape (for exclusive smokers only)
• Vapes Daily (for dual users only)

Exclusion criteria

• There will be no additional exclusion criteria for this study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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

Other: Nicotine vaping products at 1/2 market price

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

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

Other: Nicotine vaping products at 1/2 market price

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

Other: All nicotine/ tobacco products at market price