| Methods |
Consecutive assignment to treatment. Groups similar except duration of methadone significantly less in methadone group. Dropouts considered as relapsed. Intention to treat analysis. No blinding reported. |
| Participants |
30 opioid‐dependent by DSM‐IV. 15 in each group. 80% male. Mean age (1) 34.9 (2) 31.4. Duration of heroin use (1) 11.1 ± 7 (2) 6.3 ± 6.2 years. Duration of methadone use (1) 9.4 ± 6.7 (2) 3.5 ± 5.2 years. 20% employed. Mean previous treatments (1) 9.6 ± 7.5 (2) 6.9 ± 5.8. Inpatient treatment (1) hospital and addiction clinic (2) addiction clinic only. |
| Interventions |
Methadone during waiting period (dose not reported). (1) Naltrexone 100mg oral. Propofol anaesthesia induced when withdrawal evident. Mechanical ventilation. 0.8mg naloxone test every 20 min until no withdrawal. 100mg naltrexone via nasogastric tube. Range of adjunct medications. (2) Methadone tapered over 1‐2 weeks. Naltrexone maintenance as aftercare, commenced (1) immediately (2) 6 days after last methadone. |
| Outcomes |
Graph of mean withdrawal scores. Number of participants with opiate‐free urine samples during follow‐up. |
| Notes |
Withdrawal assessed by Subjective and Objective Opiate Withdrawal Scales. Country: The Netherlands |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Consecutive allocation. |
| Allocation concealment? |
High risk |
Treatments undertaken consecutively. |
| Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
High risk |
No blinding |
| Blinding?
Objective outcomes ‐ duration of treatment, completion of treatment |
Low risk |
These outcomes considered unlikely to be affected by lack of blinding. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
(1) 0/15 (2) 9/15 dropped out in first week, but data on severity of withdrawal able to be compared only for first four days. Completion of withdrawal and duration of treatment is primary outcome measure. |
| Free of selective reporting? |
Low risk |
None apparent |
| Free of other bias? |
Low risk |
None apparent |
| Other bias: Selection of comparison cohort |
Low risk |
Experimental and control cohorts selected from same population. |
| Other bias: Comparability of cohorts |
Low risk |
Groups similar except duration of methadone significantly less in methadone group. |
| Other bias: Representativeness of exposed cohort |
Low risk |
Both groups drawn from population of opioid‐dependent clients with a clear wish to attain abstinence. |
| Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |
