Kristensen 2005.
Methods | Two‐group, open‐label randomised clinical trial. 25 unmarked closed envelopes with each study medication were placed in a hat and drawn by each participant following randomisation. | |
Participants | Geographic region: Norway. N = 50. Mean age: 36 years. 76% male. Inclusion criteria: ICD10 diagnosis of opioid dependence. Exclusion criteria: younger than 25 years. |
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Interventions | 180 days of flexible dosing (methadone) and fixed dosing (buprenorphine). Buprenorphine (sublingual tablets) mean dose 16 mg per day. Methadone dose of 106 mg per day. | |
Outcomes | Retention in treatment, urinalysis. | |
Funding source | The study was funded by "Sosial‐og helsedepartementet". | |
Declarations of interest | Two authors supported to attend international congress by Schering‐Plough. | |
Notes | 50 long term (> 10 years) opioid dependent participants. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised. Unmarked, sealed envelopes participants drew from a hat. |
Allocation concealment (selection bias) | Low risk | Unmarked, sealed envelopes. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Open‐label. Objective outcome measurement not influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat. |