Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04237272 |
| Other study ID # |
Pro00089701 |
| Secondary ID |
P30CA138313 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
June 24, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Medical University of South Carolina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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.
