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 |
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| 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 |
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| 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 |
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| 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 |