| Methods |
Randomised controlled trial. Setting: inpatient treatment. |
| Participants |
86 users of heroin, methadone or both; opioid dependent by DSM‐IV, drug use confirmed by urine test. (1) 44, (2) 42; (1) 86%, (2) 74% male. 37/86 also used benzodiazepines. Mean duration opioid use 10.5 Y. Mean age 31.7 Y. Groups similar.
Excl. cr: major psychiatric or physical illness, pregnant or taking neuroleptic or antidepressant medication. |
| Interventions |
Stabilised on methadone (around 60 mg/day) for 3 days prior to detoxification, then: (1) Methadone, starting dose variable, tapered over 10 days. (2) Lofexidine,initial dose 0.6 mg/day until day 4, maintained at 2 mg/day for 3 days, then tapered over 3 days. Both drugs administered twice daily. Diazepam 3 days stabilisation then tapered over 21 days for those co dependent on benzodiazepines.
Scheduled duration of the study 20 days (10‐day treatment program followed by 10 day‐rehabilitation program). Country of origin: Europe (UK). |
| Outcomes |
Completion rate as number completing 20 days treatment. Acceptability of the treatment as daily withdrawal score (graph) and as mean morning and evening daily blood pressure (graph) and number experiencing dizziness. |
| Notes |
SOWS (10 items, 0‐3 severity) completed daily by participants.
Compliance corroborate by urine screening three times/week. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
method not reported |
| Allocation concealment (selection bias) |
Unclear risk |
method of allocation not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"after the stabilisation period, ..patients randomly assigned to either methadone syrup and placebo tablets or placebo syrup and lofexidine tablet". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
"a dedicated worker who did not have clinical contact with the patients had exclusive knowledge of urine drug screen.." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
results on all randomised participants |
