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

Primary Purpose

Tobacco Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cigarette flavor restricted and e-cigarette flavor restricted

Cigarette flavor restricted and e-cigarette flavor unrestricted

Cigarette flavor unrestricted and e-cigarette flavor restricted

Cigarette flavor unrestricted and e-cigarette flavor unrestricted

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Cigarette, E-cigarette, Behavioral Economics, Tobacco Control

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fralin Biomedical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Menthol cigarette smokers

Non-menthol cigarette smokers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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(-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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05110872

First Posted

October 11, 2021

Last Updated

January 27, 2022

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

University of Minnesota, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05110872

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

July 26, 2021 (Actual)

Primary Completion Date

August 13, 2021 (Actual)

Study Completion Date

August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Virginia Polytechnic Institute and State University

Collaborators

University of Minnesota, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder

Keywords

Cigarette, E-cigarette, Behavioral Economics, Tobacco Control

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

Investigator

Masking Description

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

Allocation

Randomized

Enrollment

307 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menthol cigarette smokers

Arm Type

Experimental

Arm Description

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

Arm Title

Non-menthol cigarette smokers

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cigarette flavor restricted and e-cigarette flavor restricted

Intervention Description

Tobacco cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace

Intervention Type

Behavioral

Intervention Name(s)

Cigarette flavor restricted and e-cigarette flavor unrestricted

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cigarette flavor unrestricted and e-cigarette flavor restricted

Intervention Description

Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace

Intervention Type

Behavioral

Intervention Name(s)

Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Intervention Description

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

Primary Outcome Measure Information:

Title

E-cigarette substitution

Description

Time Frame

1 day

Title

Cigarette demand

Description

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.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Warren K Bickel, Ph.D.

Organizational Affiliation

Fralin Biomedical Research Institute at VTC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fralin Biomedical Research Institute

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The study team will share de-identified data upon request.

Learn more about this trial

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

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