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

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Completed

CT.gov ID

NCT05110872

Collaborator

University of Minnesota (Other), National Cancer Institute (NCI) (NIH)

307

Enrollment

Location

Arms

Actual Duration (Days)

519.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Behavioral: Cigarette flavor restricted and e-cigarette flavor restricted Behavioral: Cigarette flavor restricted and e-cigarette flavor unrestricted Behavioral: Cigarette flavor unrestricted and e-cigarette flavor restricted Behavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted	N/A

Detailed 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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

307 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different cigarette and e-cigarette flavors are available. In all scenarios, a range of other tobacco products will also be available.Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different cigarette and e-cigarette flavors are available. In all scenarios, a range of other tobacco products will also be available.

Masking:

Single (Investigator)

Masking Description:

The study design included automated randomization of the conditions per person at the time of completion, via Qualtrics Software.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 26, 2021

Actual Primary Completion Date :

Aug 13, 2021

Actual Study Completion Date :

Aug 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Menthol cigarette smokers Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited.	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 Behavioral: 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 Behavioral: 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 Behavioral: 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
Experimental: Non-menthol cigarette smokers Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited.	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 Behavioral: 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 Behavioral: 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 Behavioral: 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

Arm

Intervention/Treatment

Experimental: Menthol cigarette smokers

Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited.

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

Behavioral: 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

Behavioral: 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

Behavioral: 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

Experimental: Non-menthol cigarette smokers

Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited.

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

Behavioral: 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

Behavioral: 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

Behavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Outcome Measures

Primary Outcome Measures

E-cigarette substitution [1 day]
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.
Cigarette demand [1 day]
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(-αQ0C)-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 α is the demand elasticity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fralin Biomedical Research Institute	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

Virginia Polytechnic Institute and State University
University of Minnesota
National Cancer Institute (NCI)

Investigators

Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Warren K. Bickel, Professor and director, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT05110872

Other Study ID Numbers:

VT IRB# 20-827
P01CA217806

First Posted:

Nov 8, 2021

Last Update Posted:

Feb 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Warren K. Bickel, Professor and director, Virginia Polytechnic Institute and State University

Additional relevant MeSH terms:

Tobacco Use Disorder

Study Results

No Results Posted as of Feb 11, 2022