Varenicline + Prazosin for Heavy Drinking Smokers

This is an interventional treatment trial for Cigarette Smoking focused on measuring varenicline, prazosin, cigarette smoking, alcohol drinking, sleep, dreams Read More

Inclusion Criteria:

1. at least 18 years of age;
2. current smoker [quantity of ≥ cigarettes per smoking day, frequency of ≥3 times per week, and urinary cotinine ≥2 on NicAlert dipstick;
3. at least 4 occasions of heavy drinking in the past 30 days [5 or 4 standard drinks per occasion for males and females, respectively];
4. no history of severe alcohol withdrawal syndrome;
5. no new onset of psychiatric illness or psychotropic medications in last 90 days;
6. no severe psychiatric illness [schizophrenia, bipolar disorder] or PTSD;
7. no substance dependence other than nicotine, alcohol or marijuana;
8. no medical contraindications for varenicline or prazosin;
9. are willing to take medication and wear portable sleep monitoring devices;
10. no risk for sleep apnea syndrome;
11. able to read and write in English;
12. not interested in quitting smoking immediately.

Exclusion Criteria:

1. unable to complete the informed consent;
2. do not meet criteria for heavy drinking;
3. do not meet criteria for current smokers;
4. unable to read/understand English;
5. 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;
6. meet criteria for alcohol dependence in past 12 months that is clinically severe;
7. meet criteria for drug dependence in the last 12 months aside from marijuana, nicotine and alcohol;
8. are seeking to quit smoking immediately;
9. report current psychosis or suicidality;
10. 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);

11. exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation including:

    1. any unexplained elevations in liver enzymes (i.e. transaminases, bilirubin);
    2. clinically significant, unstable cardiovascular disease/uncontrolled hypertension;
    3. hepatic or renal impairment;
    4. severe obstructive pulmonary disease;
    5. diabetes mellitus requiring insulin or certain oral medications (i.e. sulfonylureas) and an A1C hemoglobin test score of >7 for participants not prescribed these medications;
    6. baseline systolic blood pressure higher than 150 mm Hg of diastolic blood pressure higher than 95 mm Hg; (g) are scheduled for cataract surgery; (h) have a diagnosis of narcolepsy;
12. have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
13. have a history of clinically significant allergic reactions;
14. 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;
15. intend to donate blood or blood products during the treatment phase of the study;
16. 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.