Tobacco Use DisorderNCT05110872

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

A study testing Cigarette flavor restricted and e-cigarette flavor restricted, Cigarette flavor restricted and e-cigarette flavor unrestricted and Cigarette flavor unrestricted and e-cigarette flavor restricted in people with Tobacco Use Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Tobacco Use Disorder
What is being tested?: Cigarette flavor restricted and e-cigarette flavor restricted, Cigarette flavor restricted and e-cigarette flavor unrestricted and Cigarette flavor unrestricted and e-cigarette flavor restricted
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2021to 13 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fralin Biomedical Research Institute
Roanoke, Virginia, 24016

Other trials in United States

About this study

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

Read the 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.

Conditions: Tobacco Use Disorder
Being tested: 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
Keywords: Cigarette, E-cigarette, Behavioral Economics, Tobacco Control
Medical subject headings: Tobacco Use Disorder, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cigarette flavor restricted and e-cigarette flavor restrictedBehavioural
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 unrestrictedBehavioural
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 restrictedBehavioural
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 unrestrictedBehavioural
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

Study groups in NCT05110872
Study group	Role	What they receive
Menthol cigarette smokers	Experimental	Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. Receives: 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
Non-menthol cigarette smokers	Experimental	Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202113 Aug 2021

First posted8 Nov 2021
Study start26 Jul 2021
Primary completion13 Aug 2021
Study completion13 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
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: Single blind
Who is masked: Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05110872
Sponsor's protocol ID: VT IRB# 20-827
Other IDs: P01CA217806
Status last verified: Sep 2025
First submitted: 11 Oct 2021
Last updated: 7 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study team will share de-identified data upon request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus

All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMET Study 2: Effects of Cigarette and E-cigarette Flavor Restrictions on Cigarette Demand and Substitution in the Experimental Tobacco Marketplace
ClinicalTrials.gov ID: NCT05110872
Acronym / sponsor ID: VT IRB# 20-827
Conditions: Tobacco Use Disorder
Keywords: Cigarette, E-cigarette, Behavioral Economics, Tobacco Control
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
Collaborators: University of Minnesota, National Cancer Institute (NCI)
Study start: 26 Jul 2021 (actual)
Primary completion: 13 Aug 2021 (actual)
Study completion: 13 Aug 2021 (actual)
First posted: 8 Nov 2021 (actual)
Results: Posted 7 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2
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.

Arm	Type	Receives
Menthol cigarette smokers	Experimental	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 unrestrictedAdults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited.
Non-menthol cigarette smokers	Experimental	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 unrestrictedAdults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cigarette flavor restricted and e-cigarette flavor restricted1. Tobacco cigarettes will be available in the Experimental Tobacco Marketplace 2. Tobacco-flavored e-cigarettes will be available in the Experimental Tobacco Marketplace	Behavioural	Menthol cigarette smokers, Non-menthol cigarette smokers
Cigarette flavor restricted and e-cigarette flavor unrestricted1. 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	Behavioural	Menthol cigarette smokers, Non-menthol cigarette smokers
Cigarette flavor unrestricted and e-cigarette flavor restricted1. 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	Behavioural	Menthol cigarette smokers, Non-menthol cigarette smokers
Cigarette flavor unrestricted and e-cigarette flavor unrestricted1. 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	Behavioural	Menthol cigarette smokers, Non-menthol cigarette smokers

Primary outcome

Spent the Budget on E-cigarettes for Each Condition
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 average percentage of budget spent on e-cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed.
Spent Budget on Cigarettes for Each Condition
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 average percentage of the budget spent on cigarettes as a function of the restriction of cigarettes and/or e-cigarettes will be assessed.

Results and safety

Results posted to the registry on 7 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Menthol Cigarette Smokers	140	140
Non-menthol Cigarette Smokers	162	162

Primary outcome: Spent the Budget on E-cigarettes for Each Condition

Time frame: 1 day. Mean (Standard Error). Unit: percentage of spent budget

Measure	Menthol Cigarette Smokers n = 130	Non-menthol Cigarette Smokers n = 133
Cigarette and E-cigarette Restriction	10.64 (1.36)	14.87 (1.44)
Cigarette Restriction	14.74 (1.62)	14.65 (1.38)
E-cigarette restriction	8.20 (1.17)	15.03 (1.42)
No Restriction on Cigarettes or E-cigarettes	11.35 (1.45)	16.07 (1.47)

Primary outcome: Spent Budget on Cigarettes for Each Condition

Time frame: 1 day. Mean (Standard Error). Unit: percentage of spent budget

Measure	Menthol Cigarette Smokers n = 130	Non-menthol Cigarette Smokers n = 133
Cigarette and E-cigarette Restriction	55.04 (2.56)	65.82 (2.03)
Cigarette Restriction	53.05 (2.57)	65.80 (2.02)
E-cigarette Restriction	73.60 (2.13)	65.72 (2.00)
No Restriction on Cigarettes or E-cigarettes	72.05 (2.14)	65.20 (2.03)

Adverse events

Time frame: approximately 19 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menthol Cigarette Smokers	0 of 140 (0%)	0 of 140 (0%)	0 of 140
Non-menthol Cigarette Smokers	0 of 162 (0%)	0 of 162 (0%)	0 of 162

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The study team will share de-identified data upon request.

Related trials for Tobacco Use Disorder

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Warren K Bickel, Ph.D. principal investigator

Fralin Biomedical Research Institute at VTC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spent the Budget on E-cigarettes for Each Condition (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05110872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.