Furieri 2007.
Methods | Randomised placebo‐controlled double‐blind study | |
Participants | 60 participants; mean age 44.2 years; 100% male; 6.6 years on average of education; 37% married; 17% employed; 16 years on average age of alcohol use onset; 27 years of drinking on average; 17 drinks per day on average in the past 90 days; CIWA‐Ar score 25 on average Inclusion criteria: 18 to 65 years old; consuming at least 35 drinks per week during the past year and the past 90 days; being abstinent from alcohol from no longer than 14 days before baseline; meeting DSM‐IV criteria for alcohol dependence (First 1994); being in stable clinical condition; having normal serum liver transaminases; having a plasma GGT level less than 800 U/L; being diagnosed as non‐demented with Mini Mental State Examination (Folstein 1975); having no severe withdrawal signs or symptoms; scoring less than 15 on the CIWA‐Ar (Sullivan 1989); having completed seven‐day treatment for acute alcohol withdrawal Exclusion criteria: meeting diagnostic criteria for other substance intoxication or withdrawal or unstable medical or mental disorder other than alcohol dependence, except nicotine and/or caffeine; having convulsions or delirium during abstinence from alcohol; having used pharmacological agents known to reduce the convulsive threshold or to alter alcohol withdrawal or craving during the past 30 days; having a previous history of drug hypersensitivity or adverse reactions to gabapentin, diazepam or other benzodiazepines and haloperidol |
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Interventions | (1) Gabapentin, 30 participants; (2) placebo, 30 participants Drug dose: gabapentin up to 600 mg/d Participants involved in weekly BBCET (Johnson 2003b) Setting: outpatient Duration: four weeks. Country of origin: Brazil |
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Outcomes | Primary outcomes: alcohol use with the TLFB (Sobell 1992) as follows: drinks per day, drinks per drinking day, vital signs, adverse events, percentage of heavy drinking days, percentage of days of abstinence; alcohol craving using the OCDS (Bohn 1996): haematological and biochemical measurements, including transaminases and plasma GGT | |
Notes | All participants received one‐week detoxification before initiation of double‐blind treatment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation carried out by a computer programme |
Allocation concealment (selection bias) | Low risk | Quote: "The randomization code was held by a research supervisor, to be broken only in case of emergency". Study medication dispensed in medication containers, each labelled with participant code |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only completers analysis performed |
Blinding of participants and personnel (performance bias) all outcomes | Low risk | Double‐blind stated. Medication and matching placebo prepared by pharmaceutical company. Participants and psychiatrist blind to treatment condition |
Blinding of outcome assessment (detection bias) subjective | Low risk | Investigator and supervisor blind to treatment condition |
Blinding of outcome assessment (detection bias) objective | Low risk | Investigator and supervisor blind to treatment condition |