F10.2
Conditions
Interventions
Group 1: Sham(Placebo)-Stimulation during first 6 months
Group 2: Verum-Stimulation during first 6 months
Sponsors
Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
Male
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: time to relapse within first 6 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| what: Key secondary endpoint(s): 1. Overall alcohol consumption (Drinks per drinking day and percent heavy drinking days assessed with Form 90). 2.Alcohol Craving (attentional bias as experimental lab paradigm), Clinical Craving scales (OCDS; AUQ),,Consequences of drinking (DRInC), ADS, CGI, GAS, SCL-90, WHO-QoL, Hautzinger list of pleasant activities) When: during the course of entire study How: check what | — |
Countries
Germany
Contacts
Public ContactUlf J. Mueller
Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed