The majority of smokers try to quit each year, and the majority of quit attempts fail, even
when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco
products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit
smoking, switching completely to a less harmful product is likely to improve their risk of
cancer and other deleterious health outcomes. E-cigarettes, the most commonly used
non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing
to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For
smokers who have failed to quit with traditional methods, trying to switch to a less harmful
product may be more likely to help them stop smoking than trying to quit using tobacco
altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of
e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and
failed, to quit with traditional methods. Current smokers who failed to quit with
FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either
1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using
pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active
control group. Participants will select a Target Switch / Quit Date on which they will stop
smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes,
the most popular e-cigarette currently available. Participants in the Meds Group will receive
a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and
short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or
medication ad libitum while continuing to smoke in advance of their Target Switch / Quit
Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes
of interest include smoking reduction > 50% and biochemically-confirmed abstinence from
cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research
question using a rigorous design and is supported by a strong investigative team.