Trevisan 2008.
| Methods | Randomised placebo‐controlled double‐blind study | |
| Participants | 57 participants; mean age 47.7 years; 100% males; 72% white; 36.8% with high school education level; 35.1% unemployed; 14% married; 17.5% with cocaine use disorder; 19.7 heavy drinking days in the last 30 days on average Inclusion criteria: meeting DSM‐IV criteria for alcohol dependence (Spitzer 1992); requiring a detoxification intervention; being abstinent for no longer than one week; having a breathalyzer reading < 0.02 gr/dL Exclusion criteria: current DSM‐IV opiate dependence or benzodiazepine abuse or dependence; serious current psychiatric symptoms, such as suicidal or homicidal ideation; taking anticonvulsant medication, including carbamazepine, phenytoin, valproic acid or gabapentin; having medical problems that preclude safe entry into the study, including liver function tests over three times normal level, seizure disorder and pancreatitis; requiring inpatient detoxification, including participants with history of delirium tremens, cardiac disease or unstable psychiatric illness |
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| Interventions | (1) Valproic acid, 19 participants; (2) gabapentin, 19 participants; (3) placebo, 19 participants Drug dose: valproic acid, up to 1500 mg/d; gabapentin, 1200 mg/d Associated medication: lorazepam based on assessment of withdrawal symptoms using CIWA‐Ar Setting: inpatient for a few days, then outpatient Duration: four weeks. Country of origin: USA |
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| Outcomes | Primary outcome: time to relapse; number of drinking days; number of heavy drinking days; percentage of heavy drinking days Secondary outcomes: CIWA‐Ar withdrawal; alcohol craving; psychiatric stress; serum GGT; side effects |
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| Notes | Participants requiring a detoxification intervention were included. They could also receive lorazepam based on assessment of their withdrawal symptoms | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details provided |
| Allocation concealment (selection bias) | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Random effects regression models applied |
| Blinding of participants and personnel (performance bias) all outcomes | Unclear risk | Tablets identical in appearance. No other details given on blindness of participants and personnel |
| Blinding of outcome assessment (detection bias) subjective | Unclear risk | No details provided |
| Blinding of outcome assessment (detection bias) objective | Low risk | Outcome measurement not likely to be influenced by lack of blinding |
ALT: Alanine aminotransferase.
ASI: Addiction Severity Index.
AST: Aspartate aminotransferase.
AUQ: Alcohol Urge Questionnaire.
BAI: Beck Anxiety Inventory.
BBCET: Brief Behavioral Compliance Enhancement Treatment.
BDI: Beck Depression Inventory.
CBT: Cognitive‐behavioural therapy.
CDT: Carbohydrate‐deficient transferrin.
CIWA‐Ar: Clinical Institute Withdrawal Assessment for Alcohol scale, Revised.
COMBINE: Combining Medications and Behavioral Interventions.
DSM‐IV: Diagnostic and Statistic Manual of Mental Disorders (American Psychiatric Association), Fourth Edition.
EuropASI: European Addiction Severity Index.
GGT: γ‐Glutamyltransferase.
HARS: Hamilton Anxiety Rating Scale.
HDRS: Hamilton Depression Rating Scale.
ICD: International Classification of Disease.
MCV: Mean cellular volume.
MINI: Mini International Neuropsychiatric Interview.
OCDS: Obsessive Compulsive Drinking Scale.
SADD: Short Alcohol Dependence Data.
SCAN: Schedules for Clinical Assessment in Neuropsychiatry.
SCID: Structured Clinical Interview for DSM.
SCL90‐R: Symptom Checklist‐90 Revised.
TLFB: Timeline follow‐back.