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

NCT ID: NCT05110872

Last Updated: 2025-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2021-08-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Menthol cigarette smokers

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

Group Type EXPERIMENTAL

Cigarette flavor restricted and e-cigarette flavor restricted

Intervention Type BEHAVIORAL

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

Cigarette flavor restricted and e-cigarette flavor unrestricted

Intervention Type BEHAVIORAL

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

Cigarette flavor unrestricted and e-cigarette flavor restricted

Intervention Type BEHAVIORAL

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

Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Intervention Type BEHAVIORAL

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

Non-menthol cigarette smokers

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

Group Type EXPERIMENTAL

Cigarette flavor restricted and e-cigarette flavor restricted

Intervention Type BEHAVIORAL

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

Cigarette flavor restricted and e-cigarette flavor unrestricted

Intervention Type BEHAVIORAL

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

Cigarette flavor unrestricted and e-cigarette flavor restricted

Intervention Type BEHAVIORAL

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

Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Roberta Freitas-Lemos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Warren K Bickel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fralin Biomedical Research Institute at VTC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P01CA217806

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VT IRB# 20-827

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

E-cigarette Nicotine Study
NCT04709471 COMPLETED PHASE2
COMET2 Project 1 Filter Ventilation Study
NCT03637972 COMPLETED PHASE3