Brady 2002.
| Methods | Randomised placebo‐controlled double‐blind study | |
| Participants | 39 participants; mean age 40.1 years; 39% male; 46% Caucasian; BDI (Beck 1961), 11 on average; education 14 years on average; ASI (McLellan 1985) composite score 0.77 on average Inclusion criteria: meeting DSM‐IV criteria for alcohol dependence according to the SCID (First 1997) Exclusion criteria: any other substance dependence diagnosis (except nicotine and caffeine); court commitment to treatment; current use of any antidepressant, antipsychotic, anticonvulsant, anxiolytic agent or pharmacological treatment for alcoholism (disulfiram or naltrexone); severe medical illness; platelet count < 100 000/mm3 or ALT, AST > three times normal; bipolar disorder, psychotic disorder, major depressive disorder; other psychiatric disorders severe enough to interfere with study participation |
|
| Interventions | (1) Divalproex, 19 participants; (2) placebo, 20 participants Drug dose: divalproex, up to 1500 mg/d All participants received one hour per week of manualised, alcohol‐directed CBT (Kadden 1995; Monti 1989) Setting: outpatient Duration: 12 weeks. Country of origin: USA |
|
| Outcomes | Drinks per drinking day; % of days drinking, % of days heavy drinking (five or more drinks in 24‐hour period), measured using TLFB (Sobell 1992) and breath alcohol level; alcohol craving measured with the OCDS (Anton 1996) and the Craving Analogue Scale; impulsivity measured with the Barratt Impulsivity Scale (Patton 1995); irritability and aggression evaluated with the Buss‐Durkee Hostility Index (Buss 1957) and the Anger, Irritability, Aggression Scale (Coccaro 1991); depression measured with the BDI (Beck 1961) and anxiety measured with the BAI(Beck 1988); global psychological symptoms measured with the SCL90‐R (Derogatis 1977); illicit drug use evaluated with urine drug screen. Adverse effects included platelet count and liver function evaluation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Random allocation stated. No further details provided |
| Allocation concealment (selection bias) | Unclear risk | Method of concealment not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Because of participant attrition and missing data, analyses conducted on a final sample of 29 participants. Group means and last‐point‐carried‐forward analysis used for estimate of missing data |
| Blinding of participants and personnel (performance bias) all outcomes | Low risk | Manufacturer provided divalproex and matching placebo tablets. Unblinded investigator monitored laboratory reports |
| Blinding of outcome assessment (detection bias) subjective | Unclear risk | Information insufficient to permit judgement |
| Blinding of outcome assessment (detection bias) objective | Low risk | Outcome measurement not likely to be influenced by lack of blinding |