Varenicline Treatment for Active Alcoholic Smokers

Seventy smokers who are currently alcohol dependent will be enrolled to this study. If found to be study eligible they will be randomized to either active varenicline or placebo for 12 weeks. During these two weeks, they will be seen either weekly or biweekly. At the end of treatment, they will be followed up for an addition 12 weeks. Their last study visit will be 6 months after randomization.

Inclusion criteria

• Male or non-pregnant female cigarette smokers 18-years-of-age or older and reporting smoking at least an average of 10 cigarettes per day for the past year;
• Subject is alcohol dependence based on DSM IV criteria as assessed by the Mini-International Neuropsychiatric Interview (MINI) and the physician investigator;3
• Subject is currently drinking alcoholic beverages as assessed by the physician investigator;
• Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
• Subject must be able to complete all the study visits;
• Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments;
• Subject must be in good general health as determined by medical history, physical exam and physician investigator;
• Subject must provide written informed consent to participate in the study;

Exclusion criteria

• Subject is a female who is pregnant, lactating or likely to become pregnant during the trial and not willing to use an acceptable form of contraception during the medication phase, (for women of child-bearing potential, a pregnancy test will be performed prior to entry into the study and at the end of the medication phase);
• Subject has another household member in study;
• Known allergy to varenicline;
• Subject is currently (in previous 30 days) using other behavioral or pharmacologic tobacco cessation program (i.e., behavioral therapy, nicotine replacement therapy, clonidine, varenicline, bupropion SR, nortriptyline or doxepin) and unwilling or unable to discontinue use;
• Subject has an unstable medical condition as determined by the physician investigator;
• Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia;
• Subject has a personal history of renal failure or is on renal dialysis;
• Subject has a current moderate or severe depression as assessed by the Center for Epidemiologic Studies-Depression survey (CES-D) and physician investigator;
• Subject has, as defined by the Columbia Suicide Severity Rating Scale (C-SSRS) current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
• Subject has current (past 30 days) major depressive disorder or has a history of another psychiatric disorder such as psychosis or bipolar disorder;
• Subject currently uses of other tobacco products (i.e. pipe, cigar, smokeless tobacco) within the past 30 days;
• Subject currently has cancer [excluding non melanoma skin cancer] not in remission (cancer free for 5 years or more);
• Subject currently has Type 1 diabetes;
• Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
• Subject is currently on treatment with another investigational drug (within 30 days of study entry);