Fertig 2012.
| Methods | Randomised placebo‐controlled double‐blind study | |
| Participants | 130 participants; mean age 45 years; 76% male; 32% African American; 60% high school education; 36.7% married; 64% employed; 14.5 drinks/d on average; 19 years on average age of onset of regular drinking Inclusion criteria: alcohol dependence determined by DSM‐IV criteria; age 18 or older; drinking very heavily (10 or more drinks/drinking days for men; eight or more drinks/drinking days for women), with at least 40% of the days during any consecutive 60‐day interval during the 90‐day period before the clinic screening visit and at least one HDD (five or more drinks/ drinking days for men; four or more drinks/days for women) occurring within 14 days before randomisation Exclusion criteria: DSM‐IV dependence on any psychoactive substances other than alcohol and nicotine; other psychiatric illnesses; inability to be safely withdrawn from alcohol on an outpatient basis or having undergone medical detoxification during screening phase; pharmacotherapy for alcohol dependence within one month before randomisation; current psychotherapy for alcohol problems; abnormal creatinine clearance; non‐stable use of a selective serotonin reuptake inhibitor (SSRI); current use of a dual uptake inhibitor, serotonin–norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant or monoamine oxidase inhibitor antidepressant; use of anticonvulsants, hypnotics, antipsychotics, psychomotor stimulants or antianxiety agents |
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| Interventions | (1) Levetiracetam extended release, 64 participants; (2) placebo, 66 participants Drug dose: levetiracetam 500 to 2000 mg/d All participants received a manualised Brief Behavioral Compliance Enhancement Treatment (BBCET) Setting: outpatient Duration: 16 weeks. Country of origin: USA |
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| Outcomes | Primary outcome: percentage of participants with no heavy drinking days; weekly percentage of heavy drinking days Secondary outcomes: drinks per day; drinks per drinking day; percentage of days abstinent; percentage of participants abstinent; alcohol‐related consequences; mood; quality of life | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Permuted stratified block randomisation procedure applied |
| Allocation concealment (selection bias) | Low risk | Assignment of treatment condition made via web‐ or telephone‐based system according to certain predetermined stratification parameters |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat approach applied, including all randomly assigned participants Continuous outcomes analysed using a repeated‐measures mixed effects model |
| Blinding of participants and personnel (performance bias) all outcomes | Low risk | Participant, caregiver, investigator, outcomes assessor blinded to treatment assignment. Levetiracetam supplied in over‐encapsulated tablets with identical matching placebos |
| Blinding of outcome assessment (detection bias) subjective | Low risk | Participant, caregiver, investigator, outcomes assessor blinded to treatment assignment. Levetiracetam supplied in over‐encapsulated tablets with identical matching placebos |
| Blinding of outcome assessment (detection bias) objective | Low risk | Participant, caregiver, investigator, outcomes assessor blinded to treatment assignment. Levetiracetam supplied in over‐encapsulated tablets with identical matching placebos |