Krupitsky 2006.
Methods | randomised controlled trial double blind, double dummy |
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Participants | 280 patients with primary diagnosis of opioid dependence according to DSM IV , abstinence from heroin and other substance of abuse , including alcohol for at last one week, at least one relative who was willning to participate in treatment. Mean age 23.6 years, male: 72.25% |
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Interventions | group A: naltrexone 50 mg/day + fluoxeitine 20 mg/day + drug counselling (n. 70) group B: naltrexone 50 mg/day + fluoxeitine placebo + drug counselling(n. 70) group C: naltrexone placebo+ fluoxeitine 20 mg/day + drug counselling(n. 70) group D: naltrexone placebo + fluoxeitine placebo + drug counselling(n. 70) Study duration : 6 months |
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Outcomes | retention and no relapsing use of alcohol and other substance of abuse craving side effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | method of sequence generation not reported |
Allocation concealment? | Unclear risk | method for allocation concealment not reported |
Blinding? objective outcomes | Low risk | double blind, double dummy |
Blinding? subjective outcomes | Low risk | double blind, double dummy |
Incomplete outcome data addressed? All outcomes | High risk | outcomes other than retention and relapsing measured only on patients who remained in treatment |