The Effects of the Dopamine Stabilizer OSU6162 on Craving and Impulsivity in Alcohol Dependent Patients
- Conditions
- Alcohol dependenceTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-003133-34-SE
- Lead Sponsor
- A. Carlsson Research AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method