Cigarette Smoking BehaviorNCT06910202
Effects of Cigarette and E-cigarette Flavors on Substitutability in the ETM
A study testing Manipulation of nicotine/tobacco product price and availability in people with Cigarette Smoking Behavior, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Manipulation of nicotine/tobacco product price and availability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 25 May 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- Minors, as defined by state law where the study is performed (infants, children, teenagers)
- Pregnant women (can be included in minimal risk studies by mentioning in section 13.1)
- Prisoners (including all incarcerated individuals)
- Adults not capable to consent on their own behalf
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Effects of Cigarette and E-cigarette Flavors on Substitutability in the Experimental Tobacco Marketplace (20-008)
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.
Read the 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.
- 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.
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Manipulation of nicotine/tobacco product price and availability
- Keywords
- Cigarettes, E-cigarettes, Experimental Tobacco Marketplace, Substitutability, Flavors
- Medical subject headings
- Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of nicotine/tobacco product price and availabilityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Menthol cigarette smokers | Experimental | 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. Receives: Behavioral: Manipulation of nicotine/tobacco product price and availability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the intervention, session 2 (1 day per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start8 Jul 2021
- Primary completion18 May 2022
- Study completion25 May 2022
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking BehaviorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberta Freitas Lemos, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910202
- Sponsor's protocol ID
- VT IRB #25-185
- Other IDs
- 5P01CA200512-09
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.
PubMed 31350894Pope DA, Poe L, Stein JS, Kaplan BA, Heckman BW, Epstein LH, Bickel WK. Experimental tobacco marketplace: substitutability of e-cigarette liquid for cigarettes as a function of nicotine strength. Tob Control. 2019 Mar;28(2):206-211. doi: 10.1136/tobaccocontrol-2017-054024. Epub 2018 Apr 18.
PubMed 29669748Bickel WK, Pope DA, Kaplan BA, DeHart WB, Koffarnus MN, Stein JS. Electronic cigarette substitution in the experimental tobacco marketplace: A review. Prev Med. 2018 Dec;117:98-106. doi: 10.1016/j.ypmed.2018.04.026. Epub 2018 Apr 24.
PubMed 29702131Harrell MB, Loukas A, Jackson CD, Marti CN, Perry CL. Flavored Tobacco Product Use among Youth and Young Adults: What if Flavors Didn't Exist? Tob Regul Sci. 2017 Apr;3(2):168-173. doi: 10.18001/TRS.3.2.4.
PubMed 28775996Villanti AC, Johnson AL, Ambrose BK, Cummings KM, Stanton CA, Rose SW, Feirman SP, Tworek C, Glasser AM, Pearson JL, Cohn AM, Conway KP, Niaura RS, Bansal-Travers M, Hyland A. Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014). Am J Prev Med. 2017 Aug;53(2):139-151. doi: 10.1016/j.amepre.2017.01.026. Epub 2017 Mar 16.
PubMed 28318902Providenceri.com. Providence Tobacco Laws Go Into Effect January 3. Healthy Communities 2013. https://www.providenceri.com/healthy-communities/providence-tobacco-laws-go-into-effect-january-3.
FOX32News. Illinois attorney general: ban e-cigarette flavors. 2014. http://www.myfoxchicago.com/story/26238470/illinois-attorney-general-ban-e-cigarette-flavors. Accessed 11-3-14.
Durkin E. Bill would ban sale of flavored e-cigarettes. Celeste Katz Daily Politics. New York: New York Daily News; 2014.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cigarette and E-cigarette Flavors on Substitutability in the Experimental Tobacco Marketplace (20-008)
- ClinicalTrials.gov ID
- NCT06910202
- Acronym / sponsor ID
- VT IRB #25-185
- Conditions
- Cigarette Smoking Behavior
- Keywords
- Cigarettes, E-cigarettes, Experimental Tobacco Marketplace, Substitutability, Flavors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Medical University of South Carolina
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menthol cigarette smokers | Experimental | Behavioral: Manipulation of nicotine/tobacco product price and availabilityMenthol 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be between 21 and 65 years of age
- Cigarette smokers
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Manipulation of nicotine/tobacco product price and availabilityThis 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. | Behavioural | Menthol cigarette smokers |
Primary outcome
Nicotine/Tobacco Products Substitution
Time frame: During 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31350894Pope DA, Poe L, Stein JS, Kaplan BA, DeHart WB, Mellis AM, Heckman BW, Epstein LH, Chaloupka FJ, Bickel WK. The Experimental Tobacco Marketplace: Demand and Substitutability as a Function of Cigarette Taxes and e-Liquid Subsidies. Nicotine Tob Res. 2020 Apr 21;22(5):782-790. doi: 10.1093/ntr/ntz116.
- Background: PubMed 29669748Pope DA, Poe L, Stein JS, Kaplan BA, Heckman BW, Epstein LH, Bickel WK. Experimental tobacco marketplace: substitutability of e-cigarette liquid for cigarettes as a function of nicotine strength. Tob Control. 2019 Mar;28(2):206-211. doi: 10.1136/tobaccocontrol-2017-054024. Epub 2018 Apr 18.
- Background: PubMed 29702131Bickel WK, Pope DA, Kaplan BA, DeHart WB, Koffarnus MN, Stein JS. Electronic cigarette substitution in the experimental tobacco marketplace: A review. Prev Med. 2018 Dec;117:98-106. doi: 10.1016/j.ypmed.2018.04.026. Epub 2018 Apr 24.
- Background: PubMed 28775996Harrell MB, Loukas A, Jackson CD, Marti CN, Perry CL. Flavored Tobacco Product Use among Youth and Young Adults: What if Flavors Didn't Exist? Tob Regul Sci. 2017 Apr;3(2):168-173. doi: 10.18001/TRS.3.2.4.
- Background: PubMed 28318902Villanti AC, Johnson AL, Ambrose BK, Cummings KM, Stanton CA, Rose SW, Feirman SP, Tworek C, Glasser AM, Pearson JL, Cohn AM, Conway KP, Niaura RS, Bansal-Travers M, Hyland A. Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014). Am J Prev Med. 2017 Aug;53(2):139-151. doi: 10.1016/j.amepre.2017.01.026. Epub 2017 Mar 16.
- BackgroundProvidenceri.com. Providence Tobacco Laws Go Into Effect January 3. Healthy Communities 2013. https://www.providenceri.com/healthy-communities/providence-tobacco-laws-go-into-effect-january-3.
- BackgroundFOX32News. Illinois attorney general: ban e-cigarette flavors. 2014. http://www.myfoxchicago.com/story/26238470/illinois-attorney-general-ban-e-cigarette-flavors. Accessed 11-3-14.
- BackgroundDurkin E. Bill would ban sale of flavored e-cigarettes. Celeste Katz Daily Politics. New York: New York Daily News; 2014.
- Individual participant dataSharing planned: No
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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.
Roberta Freitas Lemos, 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?
A study testing Manipulation of nicotine/tobacco product price and availability in people with Cigarette Smoking Behavior, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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 5 inclusion and 10 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 9 Dec 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 9 Dec 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?
Nicotine/Tobacco Products Substitution (time frame: During the intervention, session 2 (1 day per participant)). 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 NCT06910202, which also lists 8 linked publications.
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 9 Dec 2025.