Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

Cigarette Smoking Clinical Trial

— MUSC-R 3a  

Official title:

Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456671
• Other study ID #: IRB #24-520
• Secondary ID: 5P01CA200512
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 16, 2024
• Est. completion date: September 16, 2024

Study information

• Verified date: June 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Roberta Freitas Lemos, Ph.D.
• Phone: 540-526-2016
• Email: rflemos[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: September 16, 2024
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Other:
• All nicotine/ tobacco products at market price
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
• Nicotine vaping products at 1/2 market price
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.
• Heated tobacco products at 1/2 market price.
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.
• Nicotine pouch products at 1/2 market price.
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.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Medical University of South Carolina, National Cancer Institute (NCI), University of Waterloo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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(-aQ0C)-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 a is the demand elasticity.	1 day
Primary	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