Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Inclusion criteria

• Age: 30-70 years at screening
• Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
• ≥ 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
• Participants must have signed the informed consent

Exclusion criteria

• Subject to treatment of alcohol withdrawal within 30 days of study initiation
• Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation
• Subject to treatment of depression within 3 months of study initiation
• The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
• Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
• History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
• Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values.
• Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
• Any ongoing serious psychiatric or somatic disorder
• Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
• The concurrent use of illicit drugs based on urine-toxicity test
• The need for detoxification
• Diabetes Mellitus Type 1
• Suicidal risk
• Homelessness
• Additional factors that implies to the investigator/physician that the participant will not be completing the study