Tobacco UseNCT03843047
Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace
A study testing 3 mg/mL nicotine strength e-liquid, 6 mg/mL nicotine strength e-liquid and 12 mg/mL nicotine strength e-liquid in people with Tobacco Use, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Electronic cigarettes (e-cigarettes) may be a safer alternative to conventional cigarettes and are available in a broad range of nicotine strengths. The overall goal of this project is to use an experimental analogue of the real-world tobacco marketplace to examine the effects of nicotine strength on e-cigarette… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- 3 mg/mL nicotine strength e-liquid, 6 mg/mL nicotine strength e-liquid and 12 mg/mL nicotine strength e-liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current cigarette smoker
- Current e-cigarette user (dual users arm) or have minimal prior e-cigarette experience (exclusive smokers arm)
- Cotinine levels that confirm tobacco use
- Willing to try e-cigarettes
Who cannot join
- Unstable psychiatric or medical conditions
- Immediate plans to quit smoking
- Use of prescription medication that might affect smoking or nicotine metabolism
- Pregnancy (females)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016
About this study
Official title: Effects of Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace on Tobacco Product Substitution
Electronic cigarettes (e-cigarettes) may be a safer alternative to conventional cigarettes and are available in a broad range of nicotine strengths. The overall goal of this project is to use an experimental analogue of the real-world tobacco marketplace to examine the effects of nicotine strength on e-cigarette consumption and the likelihood that current smokers will either switch to e-cigarettes (which may reduce harm) or use both products in combination (which may increase harm). Testing effects of e-cigarette nicotine strength under controlled conditions in a context that models the real world will facilitate evidence-based policies that have a net benefit to health.
Read the detailed description
The goal of tobacco regulation is to reduce tobacco-related harm and improve public health. Improving public health in this way requires thorough understanding of the processes underlying purchasing and consumption of the various products available in the complex tobacco marketplace. One product feature eligible for regulation is the nicotine content in electronic cigarettes (e-cigarettes). At present, little research has experimentally examined the influence of nicotine strength on e-cigarette consumption and the likelihood that current cigarette smokers will switch to e-cigarettes (i.e., product substitution). In the absence of such evidence, regulation designed to restrict available e-cigarette nicotine strength may have unanticipated consequences. This project will utilize an innovative method, the Experimental Tobacco Marketplace, to provide estimates of the effects of e-cigarette nicotine strength on tobacco consumption and the degree to which e-cigarette products serve as functional substitutes for cigarettes. In so doing, this project will provide rigorous tests of a novel quantitative model able to account for e-cigarette substitution effects, including effects of nicotine strength. This model, which assumes that product substitution is directly influenced by the nicotine content of tobacco products relative to their prices (a phenomenon called unit price), provides a framework that may be used to generate novel predictions and guide regulatory efforts. This project will examine the effects of four e-cigarette nicotine strengths (3, 6, 12, and 24 mg/mL) on the degree to which e-liquid substitutes for conventional cigarettes in the Experimental Tobacco Marketplace. This project will examine these effects in: a) exclusive cigarette smokers with minimal prior e-cigarette experience, and b) dual cigarette smokers/e-cigarette users. Together, the findings from this project may be used to inform regulatory action and will improve understanding of the role of nicotine strength in determining the extent to which e-cigarettes serve as functional substitutes for conventional cigarettes.
- Conditions
- Tobacco Use
- Being tested
- 3 mg/mL nicotine strength e-liquid, 6 mg/mL nicotine strength e-liquid, 12 mg/mL nicotine strength e-liquid, 24 mg/mL nicotine strength e-liquid
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg/mL nicotine strength e-liquidDrug
Availability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
6 mg/mL nicotine strength e-liquidDrug
Availability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
12 mg/mL nicotine strength e-liquidDrug
Availability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
24 mg/mL nicotine strength e-liquidDrug
Availability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
| Study group | Role | What they receive |
|---|---|---|
| Dual cigarette smokers/e-cigarette users | Other | Dual cigarette smokers/e-cigarette users will be recruited. Receives: Drug: 3 mg/mL nicotine strength e-liquid; Drug: 6 mg/mL nicotine strength e-liquid; Drug: 12 mg/mL nicotine strength e-liquid; Drug: 24 mg/mL nicotine strength e-liquid |
| Exclusive cigarette smokers | Other | Exclusive cigarette smokers with minimal prior e-cigarette experience will be recruited. Receives: Drug: 3 mg/mL nicotine strength e-liquid; Drug: 6 mg/mL nicotine strength e-liquid; Drug: 12 mg/mL nicotine strength e-liquid; Drug: 24 mg/mL nicotine strength e-liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
E-liquid substitution
The degree to which various e-liquid nicotine strengths (3, 6, 12, 24 mg/mL) substitute for conventional cigarettes will be assessed.
Measured: 1 day
Secondary outcomes (1)
Cigarette demand
The degree to which various e-liquid nicotine strengths (3, 6, 12, 24 mg/mL) influence demand form conventional 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.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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 e-liquid nicotine concentrations are available (3, 6, 12, and 24 mg/mL nicotine). In all scenarios, a range of other tobacco products will also be available.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Stein, Virginia Polytechnic Institute and State University
- Investigators
- Jeff S. Stein, Ph.D., Principal investigator, Fralin Biomedical Research Institute at VTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843047
- Sponsor's protocol ID
- 18-268
- Status last verified
- Nov 2022
- First submitted
- 12 Feb 2019
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace on Tobacco Product Substitution
- ClinicalTrials.gov ID
- NCT03843047
- Acronym / sponsor ID
- 18-268
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electronic cigarettes (e-cigarettes) may be a safer alternative to conventional cigarettes and are available in a broad range of nicotine strengths. The overall goal of this project is to use an experimental analogue of the real-world tobacco marketplace to examine the effects of nicotine strength on e-cigarette consumption and the likelihood that current smokers will either switch to e-cigarettes (which may reduce harm) or use both products in combination (which may increase harm). Testing effects of e-cigarette nicotine strength under controlled conditions in a context that models the real world will facilitate evidence-based policies that have a net benefit to health.
Detailed description
The goal of tobacco regulation is to reduce tobacco-related harm and improve public health. Improving public health in this way requires thorough understanding of the processes underlying purchasing and consumption of the various products available in the complex tobacco marketplace. One product feature eligible for regulation is the nicotine content in electronic cigarettes (e-cigarettes). At present, little research has experimentally examined the influence of nicotine strength on e-cigarette consumption and the likelihood that current cigarette smokers will switch to e-cigarettes (i.e., product substitution). In the absence of such evidence, regulation designed to restrict available e-cigarette nicotine strength may have unanticipated consequences. This project will utilize an innovative method, the Experimental Tobacco Marketplace, to provide estimates of the effects of e-cigarette nicotine strength on tobacco consumption and the degree to which e-cigarette products serve as functional substitutes for cigarettes. In so doing, this project will provide rigorous tests of a novel quantitative model able to account for e-cigarette substitution effects, including effects of nicotine strength. This model, which assumes that product substitution is directly influenced by the nicotine content of tobacco products relative to their prices (a phenomenon called unit price), provides a framework that may be used to generate novel predictions and guide regulatory efforts. This project will examine the effects of four e-cigarette nicotine strengths (3, 6, 12, and 24 mg/mL) on the degree to which e-liquid substitutes for conventional cigarettes in the Experimental Tobacco Marketplace. This project will examine these effects in: a) exclusive cigarette smokers with minimal prior e-cigarette experience, and b) dual cigarette smokers/e-cigarette users. Together, the findings from this project may be used to inform regulatory action and will improve understanding of the role of nicotine strength in determining the extent to which e-cigarettes serve as functional substitutes for conventional cigarettes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different e-liquid nicotine concentrations are available (3, 6, 12, and 24 mg/mL nicotine). In all scenarios, a range of other tobacco products will also be available.
| Arm | Type | Receives |
|---|---|---|
| Dual cigarette smokers/e-cigarette users | Other | Drug: 3 mg/mL nicotine strength e-liquid, Drug: 6 mg/mL nicotine strength e-liquid, Drug: 12 mg/mL nicotine strength e-liquid, Drug: 24 mg/mL nicotine strength e-liquidDual cigarette smokers/e-cigarette users will be recruited. |
| Exclusive cigarette smokers | Other | Drug: 3 mg/mL nicotine strength e-liquid, Drug: 6 mg/mL nicotine strength e-liquid, Drug: 12 mg/mL nicotine strength e-liquid, Drug: 24 mg/mL nicotine strength e-liquidExclusive cigarette smokers with minimal prior e-cigarette experience will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current cigarette smoker
- Current e-cigarette user (dual users arm) or have minimal prior e-cigarette experience (exclusive smokers arm)
- Cotinine levels that confirm tobacco use
- Willing to try e-cigarettes
Key exclusion criteria (4 listed)
- Unstable psychiatric or medical conditions
- Immediate plans to quit smoking
- Use of prescription medication that might affect smoking or nicotine metabolism
- Pregnancy (females)
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 |
|---|---|---|
| 3 mg/mL nicotine strength e-liquidAvailability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace | Drug | Dual cigarette smokers/e-cigarette users, Exclusive cigarette smokers |
| 6 mg/mL nicotine strength e-liquidAvailability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace | Drug | Dual cigarette smokers/e-cigarette users, Exclusive cigarette smokers |
| 12 mg/mL nicotine strength e-liquidAvailability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace | Drug | Dual cigarette smokers/e-cigarette users, Exclusive cigarette smokers |
| 24 mg/mL nicotine strength e-liquidAvailability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace | Drug | Dual cigarette smokers/e-cigarette users, Exclusive cigarette smokers |
Primary outcome
E-liquid substitution
Time frame: 1 day
The degree to which various e-liquid nicotine strengths (3, 6, 12, 24 mg/mL) substitute for conventional cigarettes will be assessed.
1 secondary outcome
Cigarette demand
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jeff S. Stein, 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 3 mg/mL nicotine strength e-liquid, 6 mg/mL nicotine strength e-liquid and 12 mg/mL nicotine strength e-liquid in people with Tobacco Use, 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 4 inclusion and 4 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 22 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
E-liquid substitution (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2022.