Skip to main content
. 2014 Feb 6;2014(2):CD002207. doi: 10.1002/14651858.CD002207.pub4

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.
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.