Schottenfield 2008.
Methods | randomised controlled trial double blind, double dummy |
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Participants | 126 opioid dependent patients according to DSM IV. Mean age: 37 years; male percentage not reported | |
Interventions | group A naltrexone 50 mg/day plus buprenorphine placebo + drug counselling (n: 43) group B: buprenorphine 8mg/day plus naltrexone placebo plus drug counselling (n. 44) group C: buprenorphine placebo plus naltrexone placebo plus drug counselling (n. 39) length of study: 3 months |
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Outcomes | retention in treatment retention in treatment without relapsing days to first heroin use days to heroin relapse ( three consecutive urine positive tests o one positive followed by two consecutive mising tests |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | quote: " a simple complete randomisation sequence was generated by a computer programme " |
Allocation concealment? | Low risk | " the sequence was maintained in the USA and disclosed only to the study pharmacist in Malaysia for preparation of double blind, double dummy drugs " |
Blinding? objective outcomes | Low risk | double blind, double dummy |
Blinding? subjective outcomes | Low risk | double blind, double dummy |
Incomplete outcome data addressed? All outcomes | Low risk | three patients withdrawn from the study, one from each group |