Skip to content

JUUL vs. Mod E-cigarette Study

Comparison of Leading E-cigarette Product Types on Relative Reinforcement Value and Tobacco Use Patterns Among Current Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237272
Enrollment
31
Registered
2020-01-23
Start date
2019-11-15
Completion date
2021-06-24
Last updated
2022-12-21

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

Conditions

Smoking, Tobacco Use

Brief 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. 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.

Interventions

OTHERPod System E-cig

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.

OTHERCustomizable Tank E-cig

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

OTHERControl

Participants will not receive any e-cigarette

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* additional tobacco use criteria * additional medical criteria

Design outcomes

Primary

MeasureTime frameDescription
Choices to SmokeWeek 3 visitThe 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)

Secondary

MeasureTime frameDescription
Average Cigarettes Per DayWeek 3Average number of cigarettes smoked per day during Week 3 of sampling

Countries

United States

Participant flow

Participants by arm

ArmCount
Pod System
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. Pod System E-cig: 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.
13
Customizable Tank
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. Customizable Tank E-cig: 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
12
Control
Participants assigned to this arm will not receive any e-cigarette Control: Participants will not receive any e-cigarette
6
Total31

Baseline characteristics

CharacteristicPod SystemTotalControlCustomizable Tank
Age, Continuous41.23 Years
STANDARD_DEVIATION 12.85
45.26 Years
STANDARD_DEVIATION 10.9
52 Years
STANDARD_DEVIATION 9.59
46.25 Years
STANDARD_DEVIATION 7.56
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants29 Participants6 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants4 Participants0 Participants3 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
11 Participants24 Participants5 Participants8 Participants
Region of Enrollment
United States
13 participants31 participants6 participants12 participants
Sex: Female, Male
Female
8 Participants18 Participants3 Participants7 Participants
Sex: Female, Male
Male
5 Participants13 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 120 / 6
other
Total, other adverse events
4 / 139 / 122 / 6
serious
Total, serious adverse events
0 / 130 / 120 / 6

Outcome results

Primary

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)

Time frame: Week 3 visit

Population: 2 participants in the customizable tank group are missing for this outcome. 1 was lost to follow up after baseline. 1 was unable to finish the Week 3 visit (missing some outcomes for this visit, but not all).

ArmMeasureValue (MEAN)Dispersion
Pod SystemChoices to Smoke26.15 Percentage of Total ChoicesStandard Deviation 27.85
Customizable TankChoices to Smoke30 Percentage of Total ChoicesStandard Deviation 31.27
ControlChoices to Smoke38.33 Percentage of Total ChoicesStandard Deviation 29.27
Secondary

Average Cigarettes Per Day

Average number of cigarettes smoked per day during Week 3 of sampling

Time frame: Week 3

Population: 1 person was lost to follow up after baseline in the customizable tank group.

ArmMeasureValue (MEAN)Dispersion
Pod SystemAverage Cigarettes Per Day10.33 Cigarettes per DayStandard Deviation 7.72
Customizable TankAverage Cigarettes Per Day9.90 Cigarettes per DayStandard Deviation 7.52
ControlAverage Cigarettes Per Day13.99 Cigarettes per DayStandard Deviation 6.67

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