Varenicline for Smoking Cessation in Heavy Drinking Smokers
Condition: Nicotine Dependence; Smoking; Heavy Drinking
MeSH terms: Tobacco Use Disorder
Intervention: Extended Varenicline Pretreatment; Short-term Varenicline Pretreatment
Intervention description: 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day before the smoking quit date followed by 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.; 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Smoking cessation; Smoking; Tobacco; Varenicline; Alcohol

Summary:

      The purpose of this study is to determine whether extended pretreatment with varenicline
      (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well
      varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol
      consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Between the ages of 18 and 75.

          2. Smoking 5 or more cigarettes per occasion at least 3 times per week.

          3. Fewer than 3 months of smoking abstinence in the past year.

          4. Motivated to stop smoking.

          5. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and
             exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks.
             Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks
             for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more
             drinks for men on an occasion.

        Exclusion Criteria:

          1. Exhibit current, clinically significant physical disease or abnormality on the basis
             of medical history, physical examination, or routine laboratory evaluation

          2. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)

          3. Clinically significant cardiovascular disease

          4. Uncontrolled hypertension

          5. Hepatic or renal impairment

          6. Severe chronic obstructive pulmonary disease

          7. Diabetes mellitus requiring insulin or oral hypoglycemic medications.

          8. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure
             higher than 95 mm Hg

          9. History of cancer (except treated basal cell or squamous cell carcinoma of the skin).

         10. History of clinically significant allergic reactions.

         11. Exhibit serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe
             major depression, panic disorder, borderline personality disorder, organic mood or
             mental disorders, or substantial suicide or violence risk) by history or psychological
             examination)

         12. Have a current diagnosis of DSM-IV drug dependence other than nicotine or alcohol.

         13. Have a current Diagnostic and Statistical Manual Diploma in Social Medicine IV
             (DSM-IV) diagnosis of alcohol dependence that is clinically severe defined by a) a
             history of seizures, delirium, or hallucinations during alcohol withdrawal, b) a
             Clinical Institute Withdrawal Assessment scale (Sullivan et al., 1989) score of > 8,
             c) report drinking to avoid withdrawal symptoms, or d) have had prior treatment of
             withdrawal.

         14. Use of another investigational drug within 30 days.

         15. Intention to donate blood or blood products during the treatment phase of the study.

         16. Use of tobacco products other than cigarettes or use of marijuana.

         17. Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or
             nortriptyline within the month prior to enrollment or intention to use medication that
             might interfere with study medication.

         18. Body Mass Index (calculated as weight in kilograms divided by the square of height in
             meters) less than 15 or greater than 38 or weight less than 45 kg.

         19. Females of childbearing potential who are pregnant, nursing, or not practicing
             effective contraception (oral, injectable, or implantable contraceptives, intrauterine
             device, or barrier method with spermicide).