NCT05110872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

18 days

First QC Date

October 11, 2021

Results QC Date

September 3, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

CigaretteE-cigaretteBehavioral EconomicsTobacco Control

Outcome Measures

Primary Outcomes (2)

  • Spent the Budget on E-cigarettes for Each Condition

    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 average percentage of budget spent on e-cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed.

    1 day

  • Spent Budget on Cigarettes for Each Condition

    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 average percentage of the budget spent on cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed.

    1 day

Study Arms (2)

Menthol cigarette smokers

EXPERIMENTAL

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 restrictedBehavioral: Cigarette flavor restricted and e-cigarette flavor unrestrictedBehavioral: Cigarette flavor unrestricted and e-cigarette flavor restrictedBehavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Non-menthol cigarette smokers

EXPERIMENTAL

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 restrictedBehavioral: Cigarette flavor restricted and e-cigarette flavor unrestrictedBehavioral: Cigarette flavor unrestricted and e-cigarette flavor restrictedBehavioral: Cigarette flavor unrestricted and e-cigarette flavor unrestricted

Interventions

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

Menthol cigarette smokersNon-menthol cigarette smokers

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

Menthol cigarette smokersNon-menthol cigarette smokers

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

Menthol cigarette smokersNon-menthol cigarette smokers

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

Menthol cigarette smokersNon-menthol cigarette smokers

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderVaping

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehavior

Results Point of Contact

Title
Dr. Freitas-Lemos
Organization
Fralin Biomedical Research Institute at Virginia Tech Carilion

Study Officials

  • Warren K Bickel, Ph.D.

    Fralin Biomedical Research Institute at VTC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The study design included automated randomization of the conditions per person at the time of completion, via Qualtrics Software.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2021

First Posted

November 8, 2021

Study Start

July 26, 2021

Primary Completion

August 13, 2021

Study Completion

August 13, 2021

Last Updated

October 7, 2025

Results First Posted

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations