Clinical trial NCT05177848: Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
Official title: Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Nicotine Vaping
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Cancer Institute (NCI)
First posted: 2022-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nicotine/Tobacco Products Substitution
timeFrame: 1 day
measure: Cigarette Demand
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
affiliation: Fralin Biomedical Research Institute at VTC
name: Warren K Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: