Trial Outcomes & Findings for Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM (NCT NCT06910202)
NCT ID: NCT06910202
Last Updated: 2025-12-09
Results Overview
The outcome measure of substitution will be collected and modeled using a virtual store. Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price (cigarette type depending on condition). Other product prices will remain at market price. Substitutability occurs as a function of different flavor conditions. The degree to which other nicotine/tobacco products substitute for usual cigarettes under varying price and flavor restriction conditions will be assessed. Mixed-effects hierarchical linear regression will be used to evaluate purchasing behavior. The model includes a three-way interaction (cigarette policy × e-cigarette policy × log(price)) and a random effect for participant. Model selection based on Bayesian Information Criterion (BIC).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
During the intervention, session 2 (1 day per participant)
Results posted on
2025-12-09
Participant Flow
Participant milestones
| Measure |
Menthol Cigarette Smokers
Menthol cigarette smokers will complete questionnaires on a computer, sample a range of tobacco products, and purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
Manipulation of nicotine/tobacco product price and availability: This study does involve experimental manipulation of nicotine/tobacco product price and availability to understand consumers' behavior. Participants will be provided with a commercially available e-cigarette to use during the study, if they wish.
Every participant will purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM
Baseline characteristics by cohort
| Measure |
Menthol Cigarette Smokers
n=25 Participants
Menthol cigarette smokers will complete questionnaires on a computer, sample a range of tobacco products, and purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
Manipulation of nicotine/tobacco product price and availability: This study does involve experimental manipulation of nicotine/tobacco product price and availability to understand consumers' behavior. Participants will be provided with a commercially available e-cigarette to use during the study, if they wish.
Every participant will purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
|
|---|---|
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Age, Continuous
|
43.4 years
STANDARD_DEVIATION 12.41 • n=4 Participants
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Sex: Female, Male
Female
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9 Participants
n=4 Participants
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Sex: Female, Male
Male
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16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
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6 Participants
n=4 Participants
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|
Race (NIH/OMB)
White
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17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=4 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
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Region of Enrollment
United States
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25 participants
n=4 Participants
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PRIMARY outcome
Timeframe: During the intervention, session 2 (1 day per participant)Population: All participants who completed at least one of the experimental purchase scenarios. Missing data for participants who did not complete a condition are noted in the outcome data table.
The outcome measure of substitution will be collected and modeled using a virtual store. Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price (cigarette type depending on condition). Other product prices will remain at market price. Substitutability occurs as a function of different flavor conditions. The degree to which other nicotine/tobacco products substitute for usual cigarettes under varying price and flavor restriction conditions will be assessed. Mixed-effects hierarchical linear regression will be used to evaluate purchasing behavior. The model includes a three-way interaction (cigarette policy × e-cigarette policy × log(price)) and a random effect for participant. Model selection based on Bayesian Information Criterion (BIC).
Outcome measures
| Measure |
Menthol Cigarette Smokers
n=25 Participants
Menthol cigarette smokers will complete questionnaires on a computer, sample a range of tobacco products, and purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
Manipulation of nicotine/tobacco product price and availability: This study does involve experimental manipulation of nicotine/tobacco product price and availability to understand consumers' behavior. Participants will be provided with a commercially available e-cigarette to use during the study, if they wish.
Every participant will purchase tobacco products in an online store under four different scenarios: a) cigarette flavor restricted and e-cigarette flavor restricted, b) cigarette flavor unrestricted and e-cigarette flavor restricted, c) cigarette flavor restricted and e-cigarette flavor unrestricted, d) cigarette flavor unrestricted and e-cigarette flavor unrestricted.
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|---|---|
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Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; Cig price increased; product: Cigarette
|
1326.25 mg of nicotine purchased
Standard Error 290.72
|
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Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; Cig price increased; product: E-Liquid
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206 mg of nicotine purchased
Standard Error 57.29
|
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Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; Cig price increased; product: NRT
|
120.83 mg of nicotine purchased
Standard Error 39.18
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Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; Cig price increased; product: OTNP
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46.79 mg of nicotine purchased
Standard Error 26.20
|
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Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; Cig price increased; product: Cigarette
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2177.2 mg of nicotine purchased
Standard Error 330.38
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; Cig price increased; product: E-Liquid
|
528 mg of nicotine purchased
Standard Error 150.78
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; Cig price increased; product: NRT
|
41.28 mg of nicotine purchased
Standard Error 16.49
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; Cig price increased; product: OTNP
|
20.72 mg of nicotine purchased
Standard Error 12.57
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: Cigarette
|
1373.2 mg of nicotine purchased
Standard Error 316.93
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: E-Liquid
|
921.6 mg of nicotine purchased
Standard Error 277.03
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: NRT
|
74.72 mg of nicotine purchased
Standard Error 28.75
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: OTNP
|
16.16 mg of nicotine purchased
Standard Error 7.55
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: OTNP
|
19.08 mg of nicotine purchased
Standard Error 9.34
|
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Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: Cigarette
|
1774.17 mg of nicotine purchased
Standard Error 425.03
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: E-Liquid
|
821 mg of nicotine purchased
Standard Error 248.81
|
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Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: NRT
|
58 mg of nicotine purchased
Standard Error 24.64
|
|
Nicotine/Tobacco Products Substitution
Cig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: OTNP
|
14.21 mg of nicotine purchased
Standard Error 7.53
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: Cigarette
|
3312.92 mg of nicotine purchased
Standard Error 491.67
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: E-Liquid
|
116 mg of nicotine purchased
Standard Error 37.08
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: NRT
|
62.33 mg of nicotine purchased
Standard Error 22.86
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: OTNP
|
13.42 mg of nicotine purchased
Standard Error 7.39
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: Cigarette
|
2182 mg of nicotine purchased
Standard Error 307.20
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: E-Liquid
|
126.72 mg of nicotine purchased
Standard Error 40.22
|
|
Nicotine/Tobacco Products Substitution
Cig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: NRT
|
96.8 mg of nicotine purchased
Standard Error 48.93
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; E-cig price increased; product: Cigarette
|
1590 mg of nicotine purchased
Standard Error 332.35
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; E-cig price increased; product: E-Liquid
|
164.16 mg of nicotine purchased
Standard Error 44.74
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; E-cig price increased; product: NRT
|
121.44 mg of nicotine purchased
Standard Error 53.82
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors restricted; E-cig price increased; product: OTNP
|
50.76 mg of nicotine purchased
Standard Error 35.23
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; E-cig price increased; product: Cigarette
|
2674.58 mg of nicotine purchased
Standard Error 503.29
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; E-cig price increased; product: E-Liquid
|
327 mg of nicotine purchased
Standard Error 103.98
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; E-cig price increased; product: NRT
|
37.17 mg of nicotine purchased
Standard Error 16.01
|
|
Nicotine/Tobacco Products Substitution
Cig & E-cig flavors unrestricted; E-cig price increased; product: OTNP
|
9.33 mg of nicotine purchased
Standard Error 5.16
|
Adverse Events
Menthol Cigarette Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Roberta Freitas Lemos
Fralin Biomedical Research Institute at VTC
Phone: 5405262106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place