| Methods |
Random allocation, method not reported. Withdrawal symptoms for 11 in each group, biochemistry & haemodynamics for 10 in each group. Participants blind to anaesthetic used. |
| Participants |
25 (8 female, 17 male) in MMT. Mean (±SE) (1) 89±23 (2) 106 ± 19 mg/day. Last dose 24h before naloxone. Mean age 29 years. Duration of addiction 90 mo, MMT 20 mo. Inpatient treatment ‐ intensive care unit and psychiatric ward. |
| Interventions |
General anaesthesia with (1) propofol (2) methohexital. Naloxone iv 0.4, 0.8, 1.6, 3.2 and 6.4mg at 15min intervals, then 0.8mg/h for 24h. Intubated and ventilated. Naltrexone 50mg/d, oral, for at least 4 weeks following detox. |
| Outcomes |
Mean daily withdrawal score. Time for score to return to baseline. Levels of catecholamines in plasma. Cardiovascular parameters. Number relapsing to heroin and completing follow‐up. |
| Notes |
Withdrawal assessed by Short Opiate Withdrawal Scale. Country: Germany |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Two groups ... each received different aesthetics according to a randomisation list." Method of sequence generation not reported. |
| Allocation concealment? |
High risk |
Patients blinded to allocation, but it appears unlikely that allocation was concealed from treating staff. |
| Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
Unclear risk |
Patients blind to allocation, but unclear whether observers and treating staff also blind. |
| 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 |
Low risk |
Exclusions and dropouts similar in two groups. |
| 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 comparison groups drawn from same population. |
| Other bias: Comparability of cohorts |
Low risk |
Demographics of groups similar. |
| Other bias: Representativeness of exposed cohort |
Low risk |
Participants drawn from methadone substitution program. |
| Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |
