Schottenfeld 1997.
Methods | Four‐group, double‐dummy, double‐blind, randomised clinical trial, using a computer‐generated random number list, but the method of concealment of the allocation is unstated. | |
Participants | Geographic region: USA.
N = 116.
Mean age: 32 years.
68% male. Inclusion criteria: DSM III‐R dependence on opioids and cocaine. Exclusion criteria: current alcohol or sedative dependence, current psychosis or suicide risk, pregnancy, inability to read/understand the ratings forms and checklists. |
|
Interventions | 24 weeks of maintenance, fixed dosing. Buprenorphine (solution) 4 mg/day or 12 mg/day. Methadone 20 mg/day or 65 mg/day. | |
Outcomes | Retention in treatment, urinalysis for opioids and cocaine, self‐reported opioid and cocaine use, self‐reported withdrawal symptoms. | |
Funding source | NIDA grants (K02‐DA0112, R18‐DA06190, R01‐DA06266), USA. | |
Declarations of interest | None reported. | |
Notes | All participants were required to participate in weekly relapse prevention group counselling sessions. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind. Oral medication (or placebo) and buprenorphine solution (or placebo). "A research pharmacist prepared all the medications and was the only person with knowledge of the drug assignment". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat. |