Magura 2009.
Methods | Two‐group, open‐label, randomised clinical trial, with randomisation through a random numbers generator. Participants randomised and allocated to treatment group by receipt of sealed envelope created by investigator not involved in recruitment. | |
Participants | Geographic region: USA (NYC prison inmates).
N = 133.
100% male. Inclusion criteria: Inmates 18 ‐ 65 years eligible for treatment, with 90 days jail term or less, residing in area after release from jail. Exclusion criteria: female gender, already in methadone maintenance treatment or took non‐prescribed street methadone in past 3 days, or evidence of psychosis or HIV infection and NESB. |
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Interventions | 12 weeks of maintenance, flexible dosing with a ceiling dose of 32 mg for BMT and 70 mg for MMT. Buprenorphine/naloxone (sublingual tablets) median dose 12 mg (range 4 ‐ 20 mg). Methadone median dose 30 mg (10 ‐ 70 mg). | |
Outcomes | Retention in treatment, self‐reported heroin use, crime (re‐incarceration). | |
Funding source | NIDA grant (R21‐DA020583), and buprenorphine donated by ReckiitBenckiser. | |
Declarations of interest | "Authors declare they have no conflict of interest". | |
Notes | Inmates. 17 participants randomised to receive buprenorphine dropped out prior to receiving medication. For this analysis used intention‐to‐treat although in published articles the 17 were not included in analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number generator. |
Allocation concealment (selection bias) | Low risk | Sealed, pre‐numbered envelopes. Random number generator used and conducted by someone not involved in recruitment. |
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 used in meta‐analyses. |