Ling 1998.
Methods | Four‐group, double‐blind, randomised multi‐site clinical trial using a random number table to pre‐label medications by pharmacy staff. | |
Participants | Geographic region: USA (12 sites).
N = 736.
Mean age: 36 years.
68% male. Inclusion criteria: DSM‐III diagnosis of opioid dependence, state or federal criteria for methadone maintenance treatment, daily use of opiates in past six months. Exclusion criteria: MMT in last 30 days, alcohol dependence, serious medical condition including AIDS, current use of neuroleptics, anticonvulsants or disulphiram, pregnancy. |
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Interventions | 16 weeks of maintenance, fixed dosing. Buprenorphine (solution) 1 mg, 4 mg, 8 mg or 16 mg/day. | |
Outcomes | Retention in treatment, urinalysis for illicit opioids, craving, and global ratings by participants and staff. | |
Funding source | NIDA grants. | |
Declarations of interest | None reported. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random numbers table". |
Allocation concealment (selection bias) | Low risk | Pharmacy‐controlled randomisation. "assigning patients to the medication that had been labelled in a blinded fashion by the research pharmacy using a random numbers table". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and staff at the sites were blind to medication and dose. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat. |