Varenicline for Alcohol Dependence

Investigation of the Efficacy and Safety of Varenicline in the Postacute Treatment of Alcohol Dependence - a Prospective, Double-blind, Placebo-controlled, Randomised Phase-II Study

The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.

Inclusion Criteria:

• diagnosis of alcohol dependence according to DSM IV
• inpatient or outpatient
• last alcohol consumption within 7-21 days before randomisation
• subjects must have gone through a detoxification program and must be free of withdrawal symptoms at randomisation
• diagnosis of nicotine dependence according to DSM IV
• sufficient knowledge of the german language
• subject is able to follow verbal and written instructions
• subject is enabled to consent
• ability of subject to understand character and individual consequences of the clinical trial
• signed and dated informed consent of the subject must bei available before start of any specific trial procedures
• subject must have a clearly stated desire to stay abstinent
• women who are postmenopausal for more than two years or women with childbearing potential who practicing two years can participate in the study

Exclusion Criteria:

• alcohol withdrawal delirium during last alcohol detoxification
• alcohol induced dementia
• severe renal insufficiency
• detoxification against subject's will
• women who are pregnant or breastfeeding or planning to become pregnant during the trial
• women with childbearing potential who not practicing a medically accepted contraception during the trial
• subjects with a known psychiatric disorder requiring treatment including a major depressive disorder, a substance dependence or abuse (besides nicotine, alcohol and cannabis)a psychosis or a dissocial personality disorder according to DSM-IV
• elevated suicide risk, defined as one positive question in the suicide section of the Mini-International Neuropsychiatric Interview (M.I.N.I.)
• subjects with acute depression, defined as a HAMD17 (german version) sum score > 9 or a BDI (german version) sum score > 12
• clinically relevant acute or chronic progressive neurologic, gastrointestinel, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
• severe infection, a alcohol-induced hepatitis or a uncontrolled arterial hypertension
• use of any medication that can effect on alcohol consumption within 14 days of study initiation including antidepressants, antipsychotics, anticonvulsives, benzodiazepines (besides given in the contect of the detoxification program, anticraving drugs as naltrexone, acamprosate and disulfiram and nicotine substitutes
• subjects with following lab parameters: AST upper fivehold normal limit, PTT < 50%, leucocytes <2/nl, haemoglobin < 9g/dl, thrombocytes < 80/nl, creatinine > 1,5mg/dl and creatinine clearance < 30ml/min
• history of cancer in 5 last years
• known allergy against ingredient of study drug
• history of myocardial infarction or stroke
• participation in a clinical trial during last 90 days prior to screening
• clinically relevant visual disturbance or ear disease