SmokingNCT04237272
JUUL vs. Mod E-cigarette Study
A study testing Pod System E-cig and Customizable Tank E-cig in people with Smoking and Tobacco Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco Use
- What is being tested?
- Pod System E-cig and Customizable Tank E-cig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 24 Jun 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- daily smoker
- interested in using e-cigs
- have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion)
- be at least 21 years of age
Who cannot join
- additional tobacco use criteria
- additional medical criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Comparison of Leading E-cigarette Product Types on Relative Reinforcement Value and Tobacco Use Patterns Among Current Smokers
Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. The majority of e-cigarettes purchased today are one of two "types:" customizable tanks or pods. These e-cigarette types differ from each other in critical ways, like nicotine delivery and sensory characteristics, that are likely to impact use by influencing the relative reinforcement value of the product. The present study will be a randomized trial investigating the impact of e-cigarette device type on reinforcement value and use among current smokers. Current smokers (n=100) will be randomly assigned to either a control group that does not receive an e-cigarette or one of two e-cigarette types: a customizable tank, or a pod. The impact of device type on relative reinforcement value will be assessed using a choice task. Participants will also take home their assigned e-cigarette for a three-week sampling period. Primary outcomes include relative reinforcement value (choices to smoke in the lab-based choice task), cigarette smoking behavior (cigarettes smoked per day during sampling), and uptake (e-cigarette puffing episodes per day during sampling).
Read the detailed description
The prevalence of e-cigarettes has risen dramatically in the United States, and the impact of these products on public health remains controversial. Proponents of e-cigarettes argue that because e-cigarettes deliver lower levels of toxicants than conventional cigarettes, they may offer reduced health risks for current smokers who switch completely. However, while e-cigarettes appear to offer a path away from smoking for a subset of smokers, a large proportion of those who try e-cigarettes abandon them after a short trial period, or continue to use both products (i.e., dual use). Complete switching from cigarettes to e-cigarettes among those who try them is modest at best. Since the ultimate impact of e-cigarettes is likely dependent on their ability to curb cigarette smoking, it is important to understand the device characteristics (in addition to user characteristics: not studied here) that contribute to their uptake. One major and perhaps most visible device factor that determines uptake is the type of e-cigarette itself. The sheer volume of e-cigarette brands makes it impossible to test the impact of each brand (over 400 estimated brands). However, most e-cigarettes can be categorized into one of four broad types with distinct characteristics: cig-a-likes, tanks, customizable tanks, and pods.
There is strong evidence that cig-a-likes deliver less nicotine, are less satisfying, and are less likely to promote switching than other device types. Thus, these devices are not included in the proposed project. Tank devices have a nicotine delivery profile differs markedly from traditional cigarettes, and thus have also not been included here. The other two types, customizable tanks and pods, corner significant portions of the e-cigarette market and differ from each other in critical ways that would be expected to impact uptake, and thus constitute our primary focus. Customizable tanks deliver nicotine in a profile that more closely models the nicotine delivery of traditional cigarettes. These devices offer a high level of customization that allows users to adjust the device until they reach their desired sensory and nicotine delivery settings. However, the customization renders them relatively complicated to learn to use. Pods (e.g., JUUL) are the newest type of e-cigarette on the market. Pods utilize nicotine salts, rather than free-base nicotine, which the company claims allows them to deliver high levels of nicotine in a profile that is comparable to traditional cigarette. They offer no customization, making them easy to use. The combination of high nicotine delivery with increased usability may increase the relative reinforcement value of these products, resulting in greater uptake than other device types. There is almost no existing research that directly compares these device types against each other. The goal of this application is to provide a preliminary assessment comparing e-cigarette device types (customizable tanks, pods) in a head-to-head design.
In a between-subjects design, adult daily smokers (n=75) who are interested in trying e-cigarettes will be randomly assigned in 1:2:2 fashion to either a control group that receives no product (n=15), or to receive one of two types of e-cigarettes to sample over a three-week period: a) customizable tank, or b) pod, (n=30/group). The design is naturalistic in that participants receiving an e-cigarette will be told to use the e-cigarette as much or as little as they would like, allowing for assessment of self-determined uptake and reinforcement. Methods include both ecological assessments (electronic daily diaries) and experimental sessions (choice and purchase tasks). Biomarkers (expired carbon monoxide) will corroborate self-reported indices of use.
- Conditions
- Smoking, Tobacco Use
- Being tested
- Pod System E-cig, Customizable Tank E-cig, Control
- Medical subject headings
- Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pod System E-cigOther
Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.
Customizable Tank E-cigOther
Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week
ControlOther
Participants will not receive any e-cigarette
| Study group | Role | What they receive |
|---|---|---|
| Pod System | Active comparator | Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. Receives: Other: Pod System E-cig |
| Customizable Tank | Active comparator | Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. Receives: Other: Customizable Tank E-cig |
| Control | Active comparator | Participants assigned to this arm will not receive any e-cigarette Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choices to Smoke
The percentage of choices to smoke the conventional cigarette at the Week 3 visit. Participants chose between smoking a conventional cigarette, using their assigned e-cigarette, and not using any tobacco product. Participants made the choice 10 times. Outcome is calculated as = ((number of choices to smoke / 10)*100)
Measured: Week 3 visit
Secondary outcomes (1)
Average Cigarettes Per Day
Average number of cigarettes smoked per day during Week 3 of sampling
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start15 Nov 2019
- Primary completion1 Jun 2021
- Study completion24 Jun 2021
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.
- Other trials for SmokingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Smith, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237272
- Sponsor's protocol ID
- Pro00089701
- Other IDs
- P30CA138313
- Status last verified
- Nov 2022
- First submitted
- 17 Jan 2020
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Leading E-cigarette Product Types on Relative Reinforcement Value and Tobacco Use Patterns Among Current Smokers
- ClinicalTrials.gov ID
- NCT04237272
- Acronym / sponsor ID
- Pro00089701
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. The majority of e-cigarettes purchased today are one of two "types:" customizable tanks or pods. These e-cigarette types differ from each other in critical ways, like nicotine delivery and sensory characteristics, that are likely to impact use by influencing the relative reinforcement value of the product. The present study will be a randomized trial investigating the impact of e-cigarette device type on reinforcement value and use among current smokers. Current smokers (n=100) will be randomly assigned to either a control group that does not receive an e-cigarette or one of two e-cigarette types: a customizable tank, or a pod. The impact of device type on relative reinforcement value will be assessed using a choice task. Participants will also take home their assigned e-cigarette for a three-week sampling period. Primary outcomes include relative reinforcement value (choices to smoke in the lab-based choice task), cigarette smoking behavior (cigarettes smoked per day during sampling), and uptake (e-cigarette puffing episodes per day during sampling).
Detailed description
The prevalence of e-cigarettes has risen dramatically in the United States, and the impact of these products on public health remains controversial. Proponents of e-cigarettes argue that because e-cigarettes deliver lower levels of toxicants than conventional cigarettes, they may offer reduced health risks for current smokers who switch completely. However, while e-cigarettes appear to offer a path away from smoking for a subset of smokers, a large proportion of those who try e-cigarettes abandon them after a short trial period, or continue to use both products (i.e., dual use). Complete switching from cigarettes to e-cigarettes among those who try them is modest at best. Since the ultimate impact of e-cigarettes is likely dependent on their ability to curb cigarette smoking, it is important to understand the device characteristics (in addition to user characteristics: not studied here) that contribute to their uptake. One major and perhaps most visible device factor that determines uptake is the type of e-cigarette itself. The sheer volume of e-cigarette brands makes it impossible to test the impact of each brand (over 400 estimated brands). However, most e-cigarettes can be categorized into one of four broad types with distinct characteristics: cig-a-likes, tanks, customizable tanks, and pods.
There is strong evidence that cig-a-likes deliver less nicotine, are less satisfying, and are less likely to promote switching than other device types. Thus, these devices are not included in the proposed project. Tank devices have a nicotine delivery profile differs markedly from traditional cigarettes, and thus have also not been included here. The other two types, customizable tanks and pods, corner significant portions of the e-cigarette market and differ from each other in critical ways that would be expected to impact uptake, and thus constitute our primary focus. Customizable tanks deliver nicotine in a profile that more closely models the nicotine delivery of traditional cigarettes. These devices offer a high level of customization that allows users to adjust the device until they reach their desired sensory and nicotine delivery settings. However, the customization renders them relatively complicated to learn to use. Pods (e.g., JUUL) are the newest type of e-cigarette on the market. Pods utilize nicotine salts, rather than free-base nicotine, which the company claims allows them to deliver high levels of nicotine in a profile that is comparable to traditional cigarette. They offer no customization, making them easy to use. The combination of high nicotine delivery with increased usability may increase the relative reinforcement value of these products, resulting in greater uptake than other device types. There is almost no existing research that directly compares these device types against each other. The goal of this application is to provide a preliminary assessment comparing e-cigarette device types (customizable tanks, pods) in a head-to-head design.
In a between-subjects design, adult daily smokers (n=75) who are interested in trying e-cigarettes will be randomly assigned in 1:2:2 fashion to either a control group that receives no product (n=15), or to receive one of two types of e-cigarettes to sample over a three-week period: a) customizable tank, or b) pod, (n=30/group). The design is naturalistic in that participants receiving an e-cigarette will be told to use the e-cigarette as much or as little as they would like, allowing for assessment of self-determined uptake and reinforcement. Methods include both ecological assessments (electronic daily diaries) and experimental sessions (choice and purchase tasks). Biomarkers (expired carbon monoxide) will corroborate self-reported indices of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pod System | Active comparator | Other: Pod System E-cigParticipants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. |
| Customizable Tank | Active comparator | Other: Customizable Tank E-cigParticipants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week sampling period. |
| Control | Active comparator | Other: ControlParticipants assigned to this arm will not receive any e-cigarette |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- daily smoker
- interested in using e-cigs
- have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion)
- be at least 21 years of age
Key exclusion criteria (2 listed)
- additional tobacco use criteria
- additional medical criteria
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 |
|---|---|---|
| Pod System E-cigParticipants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period. | Other | Pod System |
| Customizable Tank E-cigParticipants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week | Other | Customizable Tank |
| ControlParticipants will not receive any e-cigarette | Other | Control |
Primary outcome
Choices to Smoke
Time frame: Week 3 visit
The percentage of choices to smoke the conventional cigarette at the Week 3 visit. Participants chose between smoking a conventional cigarette, using their assigned e-cigarette, and not using any tobacco product. Participants made the choice 10 times. Outcome is calculated as = ((number of choices to smoke / 10)*100)
1 secondary outcome
Average Cigarettes Per Day
Time frame: Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pod System E-cig and Customizable Tank E-cig in people with Smoking and Tobacco Use, run by Medical University of South Carolina 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 2 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 21 Dec 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?
Yes. Results are posted in the registry (first posted 21 Dec 2022). 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?
Choices to Smoke (time frame: Week 3 visit). 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 21 Dec 2022.