| Methods |
randomised controlled trial,
double blind; |
| Participants |
52 Russian opioid dependent patients abstinent from heroin for at least one week. Mean age: 22 years; Patients dependent on heroin for 2,5 years on average. male: 80%. Patients completed the secondary school: 88% |
| Interventions |
naltrexone plus biweekly psycho social therapy (27) versus placebo plus biweekly psychosocial therapy (25).
naltrexone: doses and frequency of administration not specified
Study duration : 6 months |
| Outcomes |
retention in treatment
use of substance of abuse (urine analysis)
side effects |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Methos of sequence generation not reported |
| Allocation concealment? |
Low risk |
"Pharmacy staff of the Pavlov University prepared naltrexone and placebo in identically appearing capsules containing a riboflavine marker. A Amaster code was kept art Pavlov so the blind could be broken in case of emergency. Medication were dispensed double blind at each counselling session" |
| Blinding?
objective outcomes |
Low risk |
double blind; naltrexone and placebo in identically appearing capsules containing a riboflavine marker. |
| Blinding?
subjective outcomes |
Low risk |
double blind, naltrexone and placebo in identically appearing capsules containing a riboflavine marker. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
number of drop out reported for each group; reason given. Excluding patients who dropped out because relapsed to heroin 7 patients dropped out from naltrexone group and 3 from placebo group |
