Cigarette Smoking Clinical Trial
Official title:
Pilot Trial of Varenicline and Prazosin to Treat Heavy Drinking Smokers
The purpose of this study is to examine the effect of varenicline and prazosin on smoking,
drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an
FDA approved smoking cessation medication. Some smokers report sleep problems when taking
varenicline. This study will test whether using prazosin, which is an FDA-approved blood
pressure medication, in combination with varenicline reduces sleep problems that can be
associated with using varenicline for smoking cessation. In addition, the study will examine
the combined effects of these medications on smoking and drinking.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia
symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt.
Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia
symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.
The study comprises an 8-week double-blind, within-subjects, crossover design of varenicline
(up to 2mg per day) plus either prazosin (up to 8mg per day) (V+P) or placebo (V) with 20
heavy drinking smokers. Each medication phase is 3 weeks with a 2-week medication washout in
between. Participants are asked to make a practice quit attempt for 3 days the last week of
each medication phase.
This is an exploratory study to look at two primary aims:
1. Evaluate the effect of prazosin on sleep disturbance caused by varenicline in heavy
drinking smokers prior to quitting smoking.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep
discontinuity than V alone.
2. Evaluate the effect of prazosin on sleep disturbance caused by varenicline during
smoking cessation in heavy drinking smokers.
Hypothesis: V+P will result in lower rates of vivid dreams and insomnia symptoms/sleep
discontinuity than V alone We will also investigate the combined effects of prazosin and
varenicline on smoking behavior (i.e., smoking urge) and alcohol consumption (i.e., drinks
per drinking day) as exploratory aims.
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