Schottenfeld 2005.
Methods | Four‐group, double‐dummy, double‐blind, randomised clinical trial, using a computerised urn randomisation procedure, but the method of concealment of allocation is unstated. | |
Participants | Geographic region: USA.
N = 162.
Mean age: 36 years.
66% male. Inclusion criteria: at least 18 years old, at least 1 year of documented opioid dependence, DSM‐IV for opioid dependence and cocaine abuse. Exclusion criteria: current alcohol or sedative dependence, significant medical condition, current psychosis, bipolar disorder, major depression or suicide risk, pregnancy, inability to read/understand English. |
|
Interventions | 24 weeks of maintenance, fixed dosing. Buprenorphine (solution) 12 mg. Methadone 65 mg/day. | |
Outcomes | Retention in treatment, urinalysis for opioids and cocaine. | |
Funding source | NIDA grants (R01‐DA09413, K24‐DA‐00445, T01‐DA‐13108, R01‐DA‐09803‐04A2, R01‐DA‐012979), USA. | |
Declarations of interest | None reported. | |
Notes | All participants were required to participate in manual guided individual counselling (twice weekly for 12 weeks and weekly thereafter). Participants were also randomly assigned to contingency management or performance feedback. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned using a computerised urn randomisation procedure". |
Allocation concealment (selection bias) | Unclear risk | Not specified. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind ‐ oral liquid and placebo plus a sublingual liquid and placebo. "A research pharmacist who had no direct contact with any of the patients prepared all medications in advance". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat. |