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Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM

Effects of Cigarette and E-cigarette Flavors on Substitutability in the Experimental Tobacco Marketplace (20-008)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06910202
Enrollment
25
Registered
2025-04-04
Start date
2021-07-08
Completion date
2022-05-25
Last updated
2025-12-09

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

Conditions

Cigarette Smoking Behavior

Keywords

Cigarettes, E-cigarettes, Experimental Tobacco Marketplace, Substitutability, Flavors

Brief summary

In 2009, the FDA banned all flavored conventional cigarettes except menthol. While no such ban exists for e-cigarettes, proposals have emerged in several regions. Flavors are key targets for tobacco control policy, making it crucial to understand their role in substitution.The first wave of the PATH study found that 80% of youth, 73% of young adults, and 29% of older smokers used flavored products. Over 80% of young adults first used flavored tobacco, compared to about 50% of adults. Among ever-users, current tobacco use was 32% higher if their first product was flavored.One study reported that 75% of flavored product users would quit if flavors were removed. These findings highlight the importance of user type in shaping policy and raise the question of whether banning flavors would increase quitting or drive substitution. The Experimental Tobacco Marketplace (ETM) is a novel method for estimating the effects of new tobacco policies and products on consumption and substitution. By experimentally controlling product mix, prices, and policies, ETM simulates real-world conditions to assess potential policy impacts.This methodology has been used to study various policies in adult smokers under this grant: nicotine dose variations (Study 1), tobacco taxes and subsidies (Study 2), and workplace restrictions (Study 3). Study 1 found that cigarette and e-cigarette substitutability increased with e-liquid nicotine strength, with 24mg/mL showing the highest substitution. Study 2 showed that cigarette taxes reduced cigarette purchases and increased e-liquid purchases, while e-liquid subsidies increased e-liquid purchases but did not affect cigarette consumption. No study to date has experimentally examined the effects of flavored tobacco products availability on consumer behavior. The rationale for this specific proposal is to explore prospectively the possible consequences of a flavor ban on consumption and substitution with tobacco products. The results might inform tobacco control policies.

Detailed description

This study does not involve any smoking cessation interventions. 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. This study uses a within subject design. 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. Participants will complete a 1) consent and assessment session, and a product sampling phase, 2) an ETM session and a 3) follow-up session: In the consent and initial assessment session, participants will go through standard consent procedures and then provide a breath sample to confirm recent levels of smoking. They may be asked to provide a urine sample for an analysis of cotinine content. Participants will complete a timeline follow back to assess previous month's recent smoking, e-cigarette use, and consumption of nicotine products, and to determine the ETM budget. A Qualtrics survey will administer demographics questions, smoking assessments (Questionnaire on Smoking Urges-Brief, Minnesota Nicotine Withdrawal Scale, Fagerstrom Test of Nicotine Dependence, Perceived Health Risk for cigarettes and e-cigarettes), and delay discounting tasks. At the end of the session, participants will experience a trial of the ETM that will be used in the next session. For the 7-day sampling phase, they will be provided a list of available flavors and identify 5 that they would like to try. They will leave with a sample of each of the 5 flavors to try during the next few days. Participants will also be provided with a sample of any other tobacco product they wish to examine and try. They may sample any products in the smoking lab before they leave. In the ETM session, participants will buy tobacco products to use throughout the next 7 days. Participants will complete a total of 40 purchasing trials each for 7 days' worth of products. They will be exposed to 4 conditions with all cigarettes increasing in price and repeat the same conditions with all e-liquids increasing in price across trials. A balanced Latin square design will be used to present the following conditions: In the Cigarette Flavor Restricted, only conventional tobacco cigarettes will be available. In the Cigarette Flavor Unrestricted, tobacco and menthol cigarettes will be available. In the E-Cigarette Flavor Restricted, only tobacco flavor e-liquids will be available. In the E- Cigarette Flavor Unrestricted, tobacco flavor e-liquid and a variety of other flavors will be available from five broad categories: tobacco, fruit, dessert, menthol, and coffee. A range of other tobacco products will be available across conditions, such as snus, lozenge, gums, dip, and nicotine pouch. 3\) In the follow-up session, participants will be able to return the e-cigarette if they wish. They will answer Perceived Health Risk assessments, complete hypothetical purchase tasks for cigarettes and e-cigarettes, rank order the products they sampled, and complete a liking scale for every tobacco product. We will summarize demographic characteristics (e.g., age, race, income) and smoking-related measures (e.g., FTCD, QSU, PHR) using means, standard deviations, and percentages. For each product category in the ETM, we will test whether policy restrictions differentially influence purchasing of cigarettes, e-cigarettes, oral tobacco/nicotine products, and NRT products. We will use hierarchical linear regression to evaluate differences in purchasing behavior, including a three-way interaction among the cigarette policy condition, the e-cigarette policy condition, and the log-transformed manipulated commodity price, with random intercepts for individuals. Model selection will be performed to identify the best-supported combination of predictors and interaction terms. We will conduct an exhaustive model search and select the optimal model based on the lowest Bayesian Information Criterion (BIC). Model posterior probabilities will be calculated using BIC following Barbieri and Berger \[29\]. Model summary statistics will be reported using Type III sums of squares and Kenward-Roger degrees of freedom \[30\]. All analyses will be performed in R (Version 4.3.0) \[31\], and statistical significance will be defined as p \< 0.05. Additional analyses may be conducted.

Interventions

BEHAVIORALManipulation 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Be between 21 and 65 years of age * Cigarette smokers * Smoke cigarettes daily (≥ 5 cigarettes/day) * Do not use e-cigarettes regularly (no more than 9 times in the last month) * Be willing to try e-cigarettes

Exclusion criteria

* Pregnant or lactating women * Plans to move out of the area * Use of prescription medication that might affect smoking or nicotine metabolism * Unmanaged medical or psychiatric conditions * Plans to quit smoking within the next 30 days * This study will focus on cigarette smokers and dual users. We will not include individuals under the age of 21 in compliance with Virginia state law. Minors, pregnant women, prisoners, and adults not capable to consent on their own behalf will be excluded from this study. 1. Minors, as defined by state law where the study is performed (infants, children, teenagers) 2. Pregnant women (can be included in minimal risk studies by mentioning in section 13.1) 3. Prisoners (including all incarcerated individuals) 4. Adults not capable to consent on their own behalf

Design outcomes

Primary

MeasureTime frameDescription
Nicotine/Tobacco Products SubstitutionDuring the intervention, session 2 (1 day per participant)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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
25
Total25

Baseline characteristics

CharacteristicMenthol Cigarette Smokers
Age, Continuous43.4 years
STANDARD_DEVIATION 12.41
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
6 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
17 Participants
Region of Enrollment
United States
25 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
16 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 25
other
Total, other adverse events
0 / 25
serious
Total, serious adverse events
0 / 25

Outcome results

Primary

Nicotine/Tobacco Products Substitution

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).

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; Cig price increased; product: Cigarette1326.25 mg of nicotine purchasedStandard Error 290.72
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; Cig price increased; product: E-Liquid206 mg of nicotine purchasedStandard Error 57.29
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; Cig price increased; product: NRT120.83 mg of nicotine purchasedStandard Error 39.18
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; Cig price increased; product: OTNP46.79 mg of nicotine purchasedStandard Error 26.2
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; Cig price increased; product: Cigarette2177.2 mg of nicotine purchasedStandard Error 330.38
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; Cig price increased; product: E-Liquid528 mg of nicotine purchasedStandard Error 150.78
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; Cig price increased; product: NRT41.28 mg of nicotine purchasedStandard Error 16.49
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; Cig price increased; product: OTNP20.72 mg of nicotine purchasedStandard Error 12.57
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: Cigarette1373.2 mg of nicotine purchasedStandard Error 316.93
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: E-Liquid921.6 mg of nicotine purchasedStandard Error 277.03
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: NRT74.72 mg of nicotine purchasedStandard Error 28.75
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; Cig price increased; product: OTNP16.16 mg of nicotine purchasedStandard Error 7.55
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: Cigarette2182 mg of nicotine purchasedStandard Error 307.2
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: E-Liquid126.72 mg of nicotine purchasedStandard Error 40.22
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: NRT96.8 mg of nicotine purchasedStandard Error 48.93
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; Cig price increased; product: OTNP19.08 mg of nicotine purchasedStandard Error 9.34
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; E-cig price increased; product: Cigarette1590 mg of nicotine purchasedStandard Error 332.35
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; E-cig price increased; product: E-Liquid164.16 mg of nicotine purchasedStandard Error 44.74
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; E-cig price increased; product: NRT121.44 mg of nicotine purchasedStandard Error 53.82
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors restricted; E-cig price increased; product: OTNP50.76 mg of nicotine purchasedStandard Error 35.23
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; E-cig price increased; product: Cigarette2674.58 mg of nicotine purchasedStandard Error 503.29
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; E-cig price increased; product: E-Liquid327 mg of nicotine purchasedStandard Error 103.98
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; E-cig price increased; product: NRT37.17 mg of nicotine purchasedStandard Error 16.01
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig & E-cig flavors unrestricted; E-cig price increased; product: OTNP9.33 mg of nicotine purchasedStandard Error 5.16
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: Cigarette1774.17 mg of nicotine purchasedStandard Error 425.03
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: E-Liquid821 mg of nicotine purchasedStandard Error 248.81
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: NRT58 mg of nicotine purchasedStandard Error 24.64
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor restricted, E-cig flavor unrestricted; E-cig price increased; product: OTNP14.21 mg of nicotine purchasedStandard Error 7.53
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: Cigarette3312.92 mg of nicotine purchasedStandard Error 491.67
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: E-Liquid116 mg of nicotine purchasedStandard Error 37.08
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: NRT62.33 mg of nicotine purchasedStandard Error 22.86
Menthol Cigarette SmokersNicotine/Tobacco Products SubstitutionCig flavor unrestricted, E-cig flavor restricted; E-cig price increased; product: OTNP13.42 mg of nicotine purchasedStandard Error 7.39

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