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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05110872
Enrollment
302
Registered
2021-11-08
Start date
2021-07-26
Completion date
2021-08-13
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Cigarette, E-cigarette, Behavioral Economics, Tobacco Control

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.

Interventions

BEHAVIORALCigarette 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

BEHAVIORALCigarette 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

BEHAVIORALCigarette 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

BEHAVIORALCigarette 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

Sponsors

University of Minnesota
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spent the Budget on E-cigarettes for Each Condition1 dayParticipants 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 Condition1 dayParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Menthol Cigarette Smokers
Adults (21 y.o. and older) who smoke ate least 10 menthol cigarettes per day will be recruited. 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 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 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 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
130
Non-menthol Cigarette Smokers
Adults (21 y.o. and older) who smoke ate least 10 non-menthol cigarettes per day will be recruited. 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 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 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 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
133
Total263

Baseline characteristics

CharacteristicMenthol Cigarette SmokersNon-menthol Cigarette SmokersTotal
Age, Continuous49.15 years
STANDARD_DEVIATION 13.31
49.77 years
STANDARD_DEVIATION 13.95
49.46 years
STANDARD_DEVIATION 13.63
Cigarettes per day19.79 cigarettes per day
STANDARD_DEVIATION 13.05
18.18 cigarettes per day
STANDARD_DEVIATION 8.82
18.99 cigarettes per day
STANDARD_DEVIATION 10.94
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants15 Participants35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
110 Participants118 Participants228 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Black or African American
12 Participants2 Participants14 Participants
Race (NIH/OMB)
More than one race
4 Participants2 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
112 Participants124 Participants236 Participants
Region of Enrollment
United States
130 participants133 participants263 participants
Sex/Gender, Customized
Female
70 Participants58 Participants128 Participants
Sex/Gender, Customized
Male
60 Participants75 Participants135 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1400 / 162
other
Total, other adverse events
0 / 1400 / 162
serious
Total, serious adverse events
0 / 1400 / 162

Outcome results

Primary

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.

Time frame: 1 day

ArmMeasureGroupValue (MEAN)Dispersion
Menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionCigarette and E-cigarette Restriction55.04 percentage of spent budgetStandard Error 2.56
Menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionCigarette Restriction53.05 percentage of spent budgetStandard Error 2.57
Menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionE-cigarette Restriction73.60 percentage of spent budgetStandard Error 2.13
Menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionNo Restriction on Cigarettes or E-cigarettes72.05 percentage of spent budgetStandard Error 2.14
Non-menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionNo Restriction on Cigarettes or E-cigarettes65.20 percentage of spent budgetStandard Error 2.03
Non-menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionCigarette and E-cigarette Restriction65.82 percentage of spent budgetStandard Error 2.03
Non-menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionE-cigarette Restriction65.72 percentage of spent budgetStandard Error 2
Non-menthol Cigarette SmokersSpent Budget on Cigarettes for Each ConditionCigarette Restriction65.80 percentage of spent budgetStandard Error 2.02
Primary

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.

Time frame: 1 day

ArmMeasureGroupValue (MEAN)Dispersion
Menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionE-cigarette restriction8.20 percentage of spent budgetStandard Error 1.17
Menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionCigarette and E-cigarette Restriction10.64 percentage of spent budgetStandard Error 1.36
Menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionNo Restriction on Cigarettes or E-cigarettes11.35 percentage of spent budgetStandard Error 1.45
Menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionCigarette Restriction14.74 percentage of spent budgetStandard Error 1.62
Non-menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionNo Restriction on Cigarettes or E-cigarettes16.07 percentage of spent budgetStandard Error 1.47
Non-menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionCigarette and E-cigarette Restriction14.87 percentage of spent budgetStandard Error 1.44
Non-menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionE-cigarette restriction15.03 percentage of spent budgetStandard Error 1.42
Non-menthol Cigarette SmokersSpent the Budget on E-cigarettes for Each ConditionCigarette Restriction14.65 percentage of spent budgetStandard Error 1.38

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026