Skip to main content
. 2014 Feb 13;2014(2):CD008544. doi: 10.1002/14651858.CD008544.pub2

Croissant 2006.

Methods Randomised controlled open study
Participants 30 participants; mean age 45.6 years; 75% male; 25% more than 12 years of education; 50% married; 50% employed; 11.5 years average duration of alcohol dependence; 12 drinks/d on average of ethanol consumption; 17.30 drinks per drinking day on average; OCDS score 16 on average
Inclusion criteria: alcohol dependence according to both ICD‐10 and DSM‐IV; age between 18 and 65 years; knowing enough German to fill in the questionnaires provided; being committed to the goal of total abstinence; participants required to have a fixed residence
Exclusion criteria: positive screening results for opiates, amphetamine and cocaine; severe somatic, psychiatric or terminal disease; pregnancy, lactation period, suicidal tendencies and legal or illegal drug addiction (except nicotine dependence and infrequent THC consumption); participating in other clinical trials; taking antipsychotic drugs or antidepressants, carbamazepine or benzodiazepines; participants for whom oxcarbazepine or acamprosate was contraindicated; participants unable to give full informed consent
Interventions (1) Oxcarbazepine, 15 participants; (2) acamprosate, 15 participants
Drug dose: oxcarbazepine up to 1200 mg/d; acamprosate 1998 mg/d
Setting: outpatient
Duration: 12 weeks of treatment plus 12 weeks of follow‐up. Country of origin: Germany
Outcomes Primary endpoint: time to first severe relapse, based on TLFB or failure to attend clinical examinations with no reliable information on drinking status available
Secondary endpoints: time to first consumption of any ethanol; percentage of days abstinent; abstinence rates; drinks per drinking day; craving measured by total score on OCDS‐G and SCL90‐R
Evaluation of safety and tolerability: safety evaluated by biological markers of heavy drinking (GGT, MCV) and markers of possible toxicity (AST, ALT, number of thrombocytes, sodium); tolerability assessed by recording side effects using questionnaires
Notes Participants enrolled after completion of detoxification
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation stated; no further information available from the study
Allocation concealment (selection bias) High risk Open study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat basis approach followed, including all participants who received at least one dose of medication. Last observation carried forward also applied. Missing data not replaced
Blinding of participants and personnel (performance bias) 
 all outcomes High risk Unblinded study
Blinding of outcome assessment (detection bias) 
 subjective High risk Unblinded study. Data management and statistics performed by a biometric section, which was blind to drug assignment
Blinding of outcome assessment (detection bias) 
 objective Low risk Outcome measurement not likely to be influenced by lack of blinding