Varenicline + Prazosin for Heavy Drinking Smokers (NCT02193256) | Clinical Trial Compass
CompletedEarly Phase 1
Varenicline + Prazosin for Heavy Drinking Smokers
United States5 participantsStarted 2014-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. at least 18 years of age;
. current smoker \[quantity of ≥ cigarettes per smoking day, frequency of ≥3 times per week, and urinary cotinine ≥2 on NicAlert dipstick;
. at least 4 occasions of heavy drinking in the past 30 days \[5 or 4 standard drinks per occasion for males and females, respectively\];
. no history of severe alcohol withdrawal syndrome;
. no new onset of psychiatric illness or psychotropic medications in last 90 days;
. no severe psychiatric illness \[schizophrenia, bipolar disorder\] or PTSD;
. no substance dependence other than nicotine, alcohol or marijuana;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of prazosin on sleep disturbance caused by varenicline prior to quitting smoking
Timeframe: Two weeks
2
Effect of prazosin on sleep disturbance caused by varenicline during smoking cessation
. no medical contraindications for varenicline or prazosin;
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;