Kakko 2007.
Methods | Two‐group, double‐blind randomised trial using a computer‐generated random sequence. The randomisation code insulated from research staff, only the pharmacy had access. | |
Participants | Geographic region: Sweden.
N = 96.
Mean age: 34.8 years (Bup/nlx) and 36.5 years (MMT).
90% male (Bup/nlx) and 69% male (MMT). Inclusion criteria: DSM‐IV heroin dependence, aged 20 years or older. Exclusion criteria: severe psychiatric illness, severe medical condition, treatment with anti‐seizure drugs or disulphiram, pregnancy or breast‐feeding. |
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Interventions | 24 days double‐blind induction phase followed by single‐blind maintenance phase for total of 6 months. Buprenorphine/naloxone (sublingual tablets) mean dose 29.6 mg/day. Methadone mean dose 110 mg/day. | |
Outcomes | Retention in treatment and urinalysis. | |
Funding source | Swedish National Drug Policy Co‐ordinator, Stockholm County, and Schering‐Plough Sweden. | |
Declarations of interest | Two authors received research and travel grants from Schering‐Plough, one author consulted for Merck Pharmaceuticals, and Kakko received honoraria from Schering‐Plough Australia, Schering‐Plough Sweden, and ReckittBenckiser Australia. | |
Notes | All participants received cognitive‐behaviour therapy, group therapy and weekly individual counselling. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence. |
Allocation concealment (selection bias) | Low risk | "Only research pharmacist and deputy had access to codes". "research pharmacy insulated from trial staff". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind. "identical looking tablets". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat. |