| Methods |
randomised controlled trial
not blinded |
| Participants |
181 North American male heroin addicts ; 39% white, 9% black, 52% Indians. Mean age: 25,9 years. Mean years addicted to heroin: 7,9. |
| Interventions |
naltrexone alone (55) versus naltrexone plus behaviour therapy (55) versus behaviour therapy alone (71). Outpatients.
Patients who completed the entry probation and received the intervention: naltrexone (23), naltrexone plus behavior (20) behavior (15)
Naltrexone doses: 50 mg/day for the first two weeks; for the next 6 weeks 50 mg twice/week and 100 mg on Saturday; Then 100 mg twice/week and 150 mg on Friday for 16 weeks. Finally 16 weeks of gradually decreasing the dose.
Behavioral therapy: contingency contracting, relaxation training ,self‐control procedures, role playing on how to refuse heroin
study duration: 10 months |
| Outcomes |
participants who completed the entry probation into the program: they had to complete a one week inpatient detoxification program and give three clear urine in the second week. Or they could spend the two weeks on the street but giving clean urine every two days
retention in treatment for at least six months
incarceration
use of substance of abuse |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "clients were randomly assigned to one of the three treatment programs |
| Allocation concealment? |
Unclear risk |
Quote: "clients were randomly assigned to one of the three treatment programs |
| Blinding?
objective outcomes |
Low risk |
open label trial, but the outcomes are unlikely to be influenced by lack of blinding |
| Blinding?
subjective outcomes |
High risk |
open label |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
number of withdrawal reported for each group, no significance difference between groups |
