Cigarette and E-cigarette Flavors Manipulations in the Experimental Tobacco Marketplace

Tobacco Use Disorder Clinical Trial

Official title:

COMET Study 2: Effects of Cigarette and E-cigarette Flavor Restrictions on Cigarette Demand and Substitution in the Experimental Tobacco Marketplace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110872
• Other study ID #: VT IRB# 20-827
• Secondary ID: P01CA217806
• Status: Completed
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: August 13, 2021

Study information

• Verified date: January 2022
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a one-session study that participants complete remotely including consent, Experimental Tobacco Marketplace purchases, and assessments to examine the effects of cigarette and e-cigarette flavors on cigarette demand and substitution in the Experimental Tobacco Marketplace.

Description:

This study uses a mixed design (within-subject repeated measures and between-group). Participants will be assigned to two different groups according to their preferred cigarette flavor (tobacco/menthol). Every participant will complete behavioral tasks and make hypothetical purchases of tobacco products in an online store under four different scenarios: a) e-cigarette flavor restricted and cigarette flavor restricted, b) e-cigarette flavor unrestricted and cigarette flavor restricted, c) e-cigarette flavor restricted and cigarette flavor unrestricted, d) e-cigarette flavor unrestricted and cigarette flavor unrestricted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: August 13, 2021
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• currently smoke at least 10 cigarettes per day
• have smoked at least 100 cigarettes (lifetime), and
• are 21 years of age or older.

Exclusion Criteria:

• inaccurate identification of usual brand of cigarette's as menthol or non-menthol

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Cigarette flavor restricted and e-cigarette flavor restricted
Tobacco cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
• Cigarette flavor restricted and e-cigarette flavor unrestricted
Tobacco cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
• Cigarette flavor unrestricted and e-cigarette flavor restricted
Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
• Cigarette flavor unrestricted and e-cigarette flavor unrestricted
Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	National Cancer Institute (NCI), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E-cigarette substitution	Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The degree to which e-cigarettes substitute for conventional cigarettes as a function of cigarettes and e-cigarettes restriction 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
Primary	Cigarette demand	Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Product availability in the ETM depended on the experimental condition. The degree to which cigarette and e-cigarette restrictions influence demand for conventional cigarettes 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