| Methods |
randomised placebo controlled trial
double‐blind |
| Participants |
50 Spanish opioid addicts(DSM‐III‐R criteria) after detoxification ; male: 78.6 %(naltrexone), 72,7 %(placebo); mean age: 26.1 (naltrexone), 27,3 (placebo); employed: 75% (naltrexone), 54,5% (placebo) |
| Interventions |
naltrexone (28) vs placebo (22)
1st month: naltrexone for all patients: 50 mg/day for the first week; from week two to four patients received two 100 mg and one 150 mg dose per week. 2nd month: naltrexone (28) vs. placebo (22)
Detoxification and induction to naltrexone in hospital setting, naltrexone maintenance an out‐patients basis.
duration: 6 month study plus 6 month follow up |
| Outcomes |
use of primary substance: n. of participants abstinent
retention in treatment
results at follow up: 1 year: use of primary substance: n. of participants abstinent |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
method of sequence generation not described |
| Allocation concealment? |
Unclear risk |
method for allocation concealment not described |
| Blinding?
objective outcomes |
Low risk |
double blind |
| Blinding?
subjective outcomes |
Low risk |
double blind. Quote" a further measure undertaken to preserve the double blind nature of the trial was the addiction of quinine to placebo capsules to ensure the same organoleptic characteristics as naltrexone capsules" |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
number of subjects who dropped out and reason reported for each group |
