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 range18 Years
SexALL
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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;
✓. no medical contraindications for varenicline or prazosin;
Exclusion criteria
✕. unable to complete the informed consent;
✕. do not meet criteria for heavy drinking;
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
✕. 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;