Does varenicline influence alcohol consumption in alcohol dependent individuals?

INTERVENTION: Trade Name: Champix Product Name: CHAMPIX Pharmaceutical Form: Coated tablet INN or Proposed INN: varenicline tartrate Other descriptive name: Champix Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐1.0 Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: Champix Pharmaceutical Form: Coated tablet INN or Proposed INN: varenicline tartrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: Alcohol dependence Nicotine dependence in alcohol dependent individuals PRIMARY OUTCOME: Main Objective: Can the oral administration of a prescription medication for smoking cessation alter alcohol consumption in alcohol dependent individuals? Primary end point(s): Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as =5 standard drinks per day for men and =4 standard drinks per day for women, during weeks 3‐12 of the active treatment period compared to baseline. Secondary Objective: Can the oral administration of a prescription medication for smoking cessation alter nicotine consumption in alcohol dependent individuals? ; Can good compliance be accomplished with self‐administration of an oral tablet for the treatment of alcohol dependence? ; INCLUSION CRITERIA: 1) Age: 30‐70 years at screening 2) Alcohol dependence according to DSM‐IV (meeting =3 out of 7 criteria) 3) = 20 heavy drinking days (men: = 5 drinks/day, women: =4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days 4) Participants must have signed the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range