Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03843047 |
| Other study ID # |
18-268 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Virginia Polytechnic Institute and State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
