Lintzeris 2004.
Methods | Two‐group, open‐label, randomised clinical trial, with participants block‐randomised and allocated to treatment group by an independent agency. Separate randomisation schedules were used for participants in methadone maintenance and heroin users seeking treatment. | |
Participants | Geographic region: Australia (3 sites).
N = 158.
Mean age: 32 years (heroin intake), 29 years (methadone intake).
57.6% male. Inclusion criteria: diagnosis of heroin dependence, or in methadone maintenance treatment for 8 weeks or less and able to reduce to 60 mg of methadone (to allow randomisation to ongoing methadone treatment or to buprenorphine). Exclusion criteria: under 18 years of age, pregnant and/or breast‐feeding. |
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Interventions | 26 weeks of maintenance, flexible dosing. Buprenorphine (sublingual tablets) mean dose 14.5 mg. Methadone mean dose 51.2 mg (methadone intake), 49.4 mg (heroin intake). | |
Outcomes | Retention in treatment and self‐reported heroin use. | |
Funding source | None reported. | |
Declarations of interest | None reported. | |
Notes | Clinicians were advised to exercise caution but not necessarily exclude participants with concomitant medical or psychiatric conditions. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" ‐ method not specified. |
Allocation concealment (selection bias) | Low risk | "Subjects were (block) randomised and allocated by an independent agency". |
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. |