| Methods |
Three group, double‐blind, placebo controlled randomised controlled trial. Patients were stratified by race and sex and randomly assigned to a fixed dose schedule at admission.
Treatment group assignment, stabilisation dose and dosing schedules were blind to patient and clinic staff with patient contact. |
| Participants |
Geographic region: USA
Study setting: methadone treatment research clinic
n = 247, 70% male
mean age = 34 years
50% African American
62% unemployed, 84% unmarried
Eligibility criteria: 18‐50 years, history of IV opioid dependence, no chronic medical illness, absence of major mental illness, negative pregnancy test and at least three months since last treatment at the clinic. |
| Interventions |
Initial treatment of active methadone for at least 5 weeks.
15 weeks of stable dosing at 50, 20 or 0 mg per day
Gradual tapering for those receiveing active methadone from weeks 21‐26
Individual counselling and group therapy (weekly). |
| Outcomes |
Retention
Treatment compliance
Illicit drug use / Urinalysis (collected 3 x weekly, one sample selected at random for analysis for opioids, cocaine and benzodiazepines) |
| Notes |
A subsample of 0mg patients (n=44) received an 8 week induction, reaching 0mg at 9 weeks. Data for patients in alternate 0mg treatment groups are collapsed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'randomly assigned' stratified by race and sex. Unclear not enough information. |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
| Free of other bias? |
Low risk |
Baseline groups similar. |
