Fischer 1999.
Methods | Two‐group, open‐label, randomised clinical trial, with participants randomised "externally . . . independent of the investigators", but the method of concealment of allocation is unstated. | |
Participants | Geographic region: Austria.
N = 60.
Age range: 18 ‐ 39 years.
68% male. Inclusion criteria: DSM‐IV diagnosis of opioid dependence, aged 18 ‐ 45 years, willing to follow the maintenance programme and avoid using illegal drugs wherever possible. Exclusion criteria: dependence on other drugs (except cannabis), pregnancy, HIV positivity or seriously illness. |
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Interventions | 24 weeks of maintenance, flexible dosing. Buprenorphine (sublingual tablet) mean dose 7.5 mg/day (range 2 mg to 8 mg). Methadone mean dose 63 mg/d (range 20 mg to 80 mg). | |
Outcomes | Retention in treatment, urinalysis for opioids, cocaine, and benzodiazepines. | |
Funding source | None reported. | |
Declarations of interest | None reported. | |
Notes | Prior to entering trial, all participants were screened for 1 week and maintained with slow‐release oral morphine (Kapanol CSR). Weekly group psychotherapy was provided. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified. |
Allocation concealment (selection bias) | Low risk | "Randomised externally using a source independent of investigators". |
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. |