Anton 2011.
Methods | Randomised placebo‐controlled double‐blind trial | |
Participants | 150 participants; mean age 44.5 years; 82% male; 88% Caucasian; 23% heavy drinking days on average Inclusion criteria: meeting DSM‐IV criteria for alcohol dependence; consuming on average five or more standard drinks per day for men or four or more drinks per day for women; being able to maintain sobriety for four days before randomisation, living near the study site in a stable living situation Exclusion criteria: meeting DSM‐IV criteria for other substance dependence (except nicotine); using illicit drugs in the past 30 days or having a positive urine drug screen; meeting DSM‐IV criteria for an Axis I disorder; having current suicidal or homicidal ideation; needing maintenance with psychotropic or anticonvulsant medication; having unstable medical conditions; having liver enzyme (ALT and AST) levels greater than three times normal; using disulfiram, acamprosate or either of the study medications within the past 30 days; taking an opioid medication on a routine basis; having legal charges pending; having undergone more than one previous inpatient medical detoxification treatment |
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Interventions | (1) Naltrexone plus gabapentin, 50 participants; (2) naltrexone plus placebo, 50 participants; (3) placebo plus placebo, 50 participants Drug dose: naltrexone 50 mg/d; gabapentin up to 1200 mg/d Participants provided sessions of combined behavioural intervention therapy using the behavioural intervention treatment manual of the COMBINE study (Miller 2004), which combined cognitive‐behavioural therapy, motivation interviewing and 12‐step facilitation techniques in a client needs–based approach Setting: outpatient Duration: 16 weeks (gabapentin added for first six weeks). Country of origin: USA |
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Outcomes | Primary outcome measures: time to relapse to drinking; symptoms such as difficulty falling asleep and/or staying asleep, irritability and nervousness, as measured by a symptom checklist and specific scales Secondary outcome measures: percentage of days drinking; drinks per drinking day; retention in the protocol; craving for alcohol; CDT and GGT measured as change from baseline; psychological and general health functioning as measured by Beck Anxiety and Depression scales; liver function tests (ALT and AST) |
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Notes | This study has been included for the only six weeks of gabapentin use | |
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 | Low risk | Methods applied to account for missing data |
Blinding of participants and personnel (performance bias) all outcomes | Unclear risk | Double‐dummy placebo‐controlled medication design applied. Medication dispensed in identically packaged blister cards. No specific reference made to blindness of participants and personnel |
Blinding of outcome assessment (detection bias) subjective | Unclear risk | Double‐dummy placebo‐controlled medication design applied. Medication dispensed in identically packaged blister cards. No specific reference made to blindness of outcome assessors |
Blinding of outcome assessment (detection bias) objective | Low risk | Double‐dummy placebo‐controlled medication design applied. Medication dispensed in identically packaged blister cards. No further details provided Outcome measurement not likely to be influenced by lack of blinding |