Deep Brain Stimulation in Treatment Resistant Alcoholism
- Conditions
- F10.2
- Registration Number
- DRKS00003206
- Lead Sponsor
- Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 12
Inpatient detoxification with abstinence of at least two weeks prior to surgery
- No withdrawal syndrome during the one week prior to surgery
- Alcohol addiction for at least 10 years according to DSM-IV/ICD-10
- Minimum of 30 drinks on average per week over a consecutive 30-day period in
a three-month period prior to initiation of abstinence
- Treatment resistance as defined by unsuccessful long term inpatient
rehabilitation treatment of at least six months, or 2 or more rehabilitation
treatments discontinued by the patient, and at least one pharmacological therapy
for at least 2 months with one of the anti-craving drugs acamprosate, naltrexone
or disulfiram
- Educational level of at least nine years of school
- Phone number of patient for phone interviews.
- Females
- Other DSM-IV axis I disorder
- Abuse or addiction to other substances (other than nicotine) with a positive
drug test on a urine screen
- Antisocial personality (score of > 20) on the psychopathy check list PCL-R
- Visible brain damage in a CT or MRI scan
- Severe neurological or medical illness
- General contraindication to surgery and/or anesthesia
- below 80% of medians of battery of neuropsychological tests: HAWIE-R, MWTB,
LPS-3, (verbal and non-verbal intelligence tests to ensure that patients are
able to give informed consent)
- Illiterate or unable to read and write German
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint: time to relapse within first 6 months after<br>randomization
- Secondary Outcome Measures
Name Time Method what:<br>Key secondary endpoint(s): 1. Overall alcohol consumption (Drinks per drinking<br>day and percent heavy drinking days assessed with Form 90). 2.Alcohol Craving<br>(attentional bias as experimental lab paradigm), Clinical Craving scales (OCDS;<br>AUQ),,Consequences of drinking (DRInC), ADS, CGI, GAS, SCL-90, WHO-QoL,<br>Hautzinger list of pleasant activities)<br>When:<br>during the course of entire study<br>How: check what