Alcohol dependence
Conditions
Interventions
Product Name: (-)-OSU6162
Product Code: OSU6162
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
A. Carlsson Research AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: •Have a current use of any psychoactive medication •Fulfils DSM IV diagnosis of any other substance dependence disorder (except nicotine) •Fulfils DSM IV diagnosis of any major psychological or psychiatric illness e.g. schizophrenia, bipolar disorder and major depression •Previous withdrawal-induced delirium tremens or seizures •Presence of any serious somatic or neurological disorder e.g. significant electrolytic imbalance, liver cirrhosis, kidney failure, dementia or Wernicke-Korsakow •Presence of any previous heart disease or clinically relevant ECG abnormality e.g. arrhythmias, bundle branch block or QT interval or T wave alterations (all subjects with intermediate or high risk for Long QT syndrome will be excluded) •Impaired sense of smell •Use of any illegal drugs for the last 30 days •Traces of alcohol as measured by breathalyzer on the day of the testing (Day 14) and the three rescheduled test occasions •Traces of any other psychoactive substance (e.g. central stimulant amines, THC, benzodiazepines, opiates, cocaine) in urine sample on inclusion day or during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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.;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. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Contacts
Public ContactResearch coordinator
Karolinska Institutet
Outcome results
None listed