The Effects of the Dopamine Stabilizer (-)-OSU6162 on Craving and Impulsivity in Alcohol Dependent Patients

INTERVENTION: Product Name: (‐)‐OSU6162 Product Code: OSU6162 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Alcohol dependence Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: The aim of this study is to investigate the effects of the dopamine stabilizer (‐)‐OSU6162 on cue‐ and priming‐induced craving responses in alcohol dependence individuals. Primary end point(s): The primary end point will be the difference in subjectively experienced alcohol craving between a) alcohol‐ and non‐alcohol related cues and b) pre‐ and post alcohol priming. Craving is operationally defined as 1) The composite score on the Short version of Desire for Alcohol Questionnaire (Short‐DAQ), 2) The score on a Visual Analog Scale (VAS) single item craving question. Secondary Objective: To investigate the treatment effects of (‐)‐OSU6162 on cognitive performance including impulsiveness in alcohol dependent individuals by using a neuropsychological test battery.; ; To investigate the treatment effects of (‐)‐OSU6162 on alcohol consumption as well as smoking quantity and frequency. Timepoint(s) of evaluation of this end point: On day 14 of treatment, the primary end‐points of the trial are evaluated following alcohol‐cue session, non‐alcohol‐cue session and alcohol‐priming session, respectively. SECONDARY OUTCOME: Secondary end point(s): 1) physiological craving responses (heart‐rate, blood‐pressure, blood‐cortisol) between a) alcohol‐ and non‐alcohol related cues and b) pre‐ and post alcohol priming. ; ; 2) differences in subjectively experienced mood between a) alcohol‐ and non‐alcohol related cues and b) pre‐ and post alcohol priming. ; ; 3) Differences in neuropsychological functioning including impulsivity (as measured by the CANTAB) between (‐)‐OSU6162 and placebo treatment ; ; 4) Differences in alcohol and smoking quantity and frequency as measured by TLFB between (‐)‐OSU6162 and placebo treatment Timepoint(s) of evaluation of this end point: On day 14 of treatment INCLUSION CRITERIA: •Male or a non‐pregnant/non‐nursing female between 20 and 55 years of age •Minimum of nine years of education •Fulfils at least 4 out of 7 criteria for alcohol dependence according to DSM‐IV, at least one of the criteria for loss of control of drinking or an inability to cut down or quit needs to be fulfilled •30 heavy drinking days (at least 5 or 4 standard drinks per day for men and women respectively) within the last 60 days before screening •Minimum 7 and maximum 14 alcohol‐free days before day of inclusion •Be willing to give informed consent and comply with study procedures 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 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range