Mueller 1997.
| Methods | Randomised placebo‐controlled double‐blind study | |
| Participants | 29 participants; mean age 38.7 years; 60% male; 90% Caucasian; 50% married; 24 years on average age of alcoholism onset; all alcohol dependents (16 drinks/drinking day on average) Inclusion criteria: adults with alcohol abuse or dependence as defined in the DSM‐III‐R (APA 1987) admitted for treatment of alcohol withdrawal Exclusion criteria: younger than 18 years old; prior or current history of epilepsy (excluding alcohol withdrawal seizures); existing pregnancy or consideration thereof within the next year; major cognitive limitations that would impair consent; psychosis; allergy to carbamazepine; cirrhosis; liver function tests elevated more than 2.5 times the upper limits of normal; cardiomyopathy or arrhythmia; history of immune compromise; medical conditions requiring active medical pharmacological management; current use of or withdrawal from opiates, benzodiazepines or barbiturates; lack of a significant other who could corroborate the participant's self‐report |
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| Interventions | (1) Carbamazepine, 13 participants; (2) placebo, 16 participants Drug dose: carbamazepine 600 mg/d verifying blood concentration to be close to 6 mg/L. Setting: inpatient for around five days, then outpatient Duration: 12 months. Country of origin: USA |
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| Outcomes | Retention in treatment; drinking behaviour (mean time to first drink, mean time to return to heavy drinking, drinks per drinking day and maximum number of heavy drinking days); mood and functioning; side effects | |
| Notes | Treatment started after alcohol detoxification | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants randomly assigned by a biostatistician (urn randomisation) |
| Allocation concealment (selection bias) | Low risk | Dispensing pharmacist aware of medication group assignment; however did not interact with participants |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis and last point carried forward analysis applied |
| Blinding of participants and personnel (performance bias) all outcomes | Low risk | Double‐blind stated; measures adopted to protect blindness of participants and personnel. Dispensing pharmacist aware of medication group assignment but did not interact with participants |
| Blinding of outcome assessment (detection bias) subjective | Low risk | Double‐blind stated; measures adopted to protect blindness of outcome assessors |
| Blinding of outcome assessment (detection bias) objective | Low risk | Double‐blind stated; measures adopted to protect blindness of outcome assessors |