New Approaches to Smoking Cessation in Heavy Drinkers
Condition: Nicotine Dependence; Cigarette Smoking; Alcohol Consumption; Heavy Drinking
MeSH terms: Tobacco Use Disorder; Alcoholic Intoxication; Alcohol Drinking
Intervention: Varenicline
Intervention description: 12-weeks of treatment. Dose will be titrated as follows:
Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day
Intervention MeSH terms: Varenicline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Quit smoking; Quit drinking

Summary:

      The purpose of this study is to develop and test an integrated cognitive-behavioral
      intervention for smoking and alcohol among heavy drinking smokers. The current pre-pilot
      phase will be used to refine this protocol for the subsequent randomized, controlled pilot
      phase. The current study phase has two parts: 1) an intake session and brief physical; 2) a
      12-week treatment phase in which participants receive varenicline (Chantix) and weekly,
      personalized counseling.
    

Eligibility criteria:

        Inclusion Criteria:

          1. are at least 18 years of age;

          2. report smoking 100 cigarettes over lifetime and currently smoke at least twice weekly
             on average in the past 90 days and have a urinary cotinine level of >=30ng/mL by
             semi-quantitative analysis, and/or >= 2 on a NicAlert dipstick

          3. are interested in quitting smoking;

          4. understand English;

          5. exceed National Institute on Alcohol Abuse and Alcoholism heavy drinking criteria
             (i.e., for men, >14 drinks/week or 5 drinks/day at least once per month over the past
             12 months; for women, >7 drinks/week or >4 drinks/day at least once per month over the
             past 12 months.

        Exclusion Criteria:

          1. meet criteria for alcohol dependence in the past 12 months that is clinically severe
             defined by

               -  a history of seizures, delirium, or hallucinations during alcohol withdrawal;

               -  a Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of
                  > 8;

               -  report drinking to avoid withdrawal symptoms, or d) have had prior treatment of
                  withdrawal;

               -  have required medical treatment of alcohol withdrawal within the past 6 months;

          2. are currently enrolled in alcohol treatment;

          3. meet criteria for drug dependence in the past 12 months; with the exception of
             marijuana dependence

          4. exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe
             major depression, panic disorder, borderline personality disorder, organic mood or
             mental disorders by history or psychological examination;

          5. report current suicidality (past 12 months), or report suicide attempts within the
             past 10 years, assessed with the Columbia Suicide Severity Rating Scale;

          6. exhibit current, clinically significant physical disease or abnormality based on
             medical history, physical examination, or routine laboratory evaluation including:

               -  any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin);

               -  clinically significant, unstable cardiovascular disease/uncontrolled
                  hypertension;

               -  hepatic or renal impairment;

               -  severe obstructive pulmonary disease;

               -  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;

               -  baseline systolic blood pressure higher than 150 mm Hg or diastolic blood
                  pressure higher than 95 mm Hg;

          7. are cognitively impaired;

          8. are unable to read/understand English;

          9. 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);

         10. report new onset of psychiatric disorders or new psychotropic medications within the
             past 3 months, except individuals who are on a stable dose of a Selective Serotonin
             Reuptake Inhibitor for at least two months or who report occasional use of
             prescription sleep aids that they are willing to discontinue;

         11. have used another investigational drug within 30 days or have used medications to
             treat alcohol (e.g., naltrexone, topiramate, acamprosate, disulfiram) or nicotine use
             (e.g., clonidine, varenicline, bupropion, nicotine replacement) in the past 3 months
             or intend to use these medications; (prior use of nicotine replacement in situations
             where smoking is not permitted (e.g., planes) without the intention to quit smoking is
             not exclusionary at screening)

         12. intend to donate blood or blood products during the treatment phase of the study;

         13. have a history of cancer (except treated basal cell or squamous cell carcinoma of the
             skin);

         14. have a history of serious hypersensitivity reactions or skin reactions to varenicline.