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About
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.
Full description
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:
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.
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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Inclusion criteria
Exclusion criteria
unable to complete the informed consent;
do not meet criteria for heavy drinking;
do not meet criteria for current smokers;
unable to read/understand English;
exhibit serious psychiatric illness (i.e. schizophrenia, bipolar disorder, severe major depression, panic disorder, borderline personality disorder), organic mood or mental disorders by history of psychological examination;
meet criteria for alcohol dependence in past 12 months that is clinically severe;
meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
are seeking to quit smoking immediately;
report current psychosis or suicidality;
are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide);
exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:
have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
have a history of clinically significant allergic reactions;
have used any psychotropic drug in the past month, except individuals who are on a stable dose of a Selective Serotonin Reuptake Inhibitor for at least two months;
intend to donate blood or blood products during the treatment phase of the study;
have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 28 or weight less than 45 kg.
Primary purpose
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Interventional model
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5 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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