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

January 27, 2022 updated by: Warren K. Bickel, Virginia Polytechnic Institute and State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
  1. Tobacco cigarettes will be available in the Experimental Tobacco Marketplace
  2. Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
Behavioral: Cigarette flavor restricted and e-cigarette flavor unrestricted
  1. Tobacco cigarettes will be available in the Experimental Tobacco Marketplace
  2. 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
  1. Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace
  2. Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
Behavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted
  1. Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace
  2. 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
  1. Tobacco cigarettes will be available in the Experimental Tobacco Marketplace
  2. Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
Behavioral: Cigarette flavor restricted and e-cigarette flavor unrestricted
  1. Tobacco cigarettes will be available in the Experimental Tobacco Marketplace
  2. 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
  1. Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace
  2. Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace
Behavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted
  1. Tobacco and menthol cigarettes will be available in the Experimental Tobacco Marketplace
  2. Tobacco-flavored and a range of flavored e-cigarettes will be available in the Experimental Tobacco Marketplace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-cigarette substitution
Time Frame: 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.
1 day
Cigarette demand
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

National Cancer Institute (NCI)
University of Minnesota

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Actual)

August 13, 2021

Study Completion (Actual)

August 13, 2021

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VT IRB# 20-827
  • P01CA217806 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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