Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06264154 |
Other study ID # |
854051 |
Secondary ID |
R01CA287474-01 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2024 |
Est. completion date |
December 2027 |
Study information
Verified date |
February 2024 |
Source |
University of Pennsylvania |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This between-subjects study aims to evaluate the effect of flavor on initial and sustained
switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After
measuring baseline cigarette smoking rate, participants will be randomized to a six-week
regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be
instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated
subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible
cigarettes will be assessed as mechanisms.
Description:
The average smoker will attempt to quit smoking at least 30 times before abstaining for 12
months or longer. These attempts typically occur over decades of smoking, carcinogen and
toxicant exposure, resulting in 480,000 deaths annually. As highlighted in the Surgeon
General's Report, helping smokers who cannot quit smoking switch to less harmful
non-combustible nicotine-containing products, such as e-cigarettes, has the potential to
reduce this health burden dramatically. Substituting e-cigarettes for combustible cigarettes
might only be possible for persistent smokers if e-cigarettes are accessible and appealing.
Harm reduction proponents have advocated for the continued availability of e-cigarette
flavors to appeal to and aid cigarette smokers unable to quit with traditional methods. Yet,
there are no prospective studies of the effect of flavor on initial and sustained switching
from combustible to electronic cigarettes. Converging laboratory, epidemiological, and
clinical research suggests that fruit-flavored e-cigarettes with nicotine may be a viable
substitute for combustible cigarettes among persistent smokers. The proposed study seeks to
answer two novel questions relevant to public health and the regulation of e-cigarette
flavoring. First, do persistent smokers substitute fruit-flavored e- cigarettes more readily
than traditional-flavored e-cigarettes (tobacco or menthol) for combustible cigarettes?
Second, are fruit-flavored e-cigarettes more rewarding and reinforcing than
traditional-flavored e-cigarettes, and do these effects facilitate switching? The proposed
research will fill these gaps in the evidence base by randomizing 210 persistent cigarette
smokers to a six-week regimen of fruit-flavored (FF: watermelon and blueberry, n=70),
tobacco-flavored (TF n=70) or menthol-flavored (MF n=70) e-cigarettes in a between-subjects
design. Baseline smoking rate will be established during days 1-5. After biochemically
verified overnight cigarette smoking abstinence, laboratory visits on days 6 and 7 will
assess flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes
relative to combustible cigarettes. Participants will then switch from cigarette smoking to
e-cigarette use for six weeks. Participants will collect spent cigarette filters daily to
assess cigarettes smoked per day (cpd) if they smoke. The primary outcome measure is the
longitudinal daily count of cigarettes from baseline to the end of the six-week switch
period, with cigarettes per day at a 6-month follow-up as a secondary endpoint.