| Methods |
Random allocation by senior pharmacist, computer generated numbers. Treatment and outcome assessment not blinded. Groups similar on demographics. |
| Participants |
70 opioid dependent by DSM‐IV, (1) 14 (2) 10 in methadone treatment. Group sizes (1) 36 (2) 34. Treatment commenced by (1) 26 (2) 21. 77% male, mean age 30, 62% single, 28% employed. Exclusion criteria included severe psychiatric or medical condition, pregnancy, dependence on alcohol, cocaine or benzodiazepines. |
| Interventions |
(1) Naltrexone 100mg; propofol anaesthesia when withdrawal apparent; intubated. Overnight in intensive care unit; 50mg naltrexone next day before transfer to inpatient substance abuse clinic. (2) Clonidine (divided doses) 0.6mg/day for 3 days, then tapered and ceased after day 7. Both groups had 1 week inpatient care in substance use clinic following detoxification. |
| Outcomes |
Number completing detoxification (defined as 3 days of retention in anaesthesia treatment or 7 days in standard inpatient treatment, without drug use). Self‐report abstinence at 3, 6, 12 months. Number commencing naltrexone. Mean days in treatment. |
| Notes |
Withdrawal severity not assessed. No urine screening reported. Country: Switzerland |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "Participants ... were randomly assigned by computer‐generated numbers..." |
| Allocation concealment? |
Low risk |
Quote: "The senior pharmacist of the psychiatric teaching hospital was responsible for the centralised randomisation process and remained unaware of the participants' characteristics or identities." |
| Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
High risk |
No blinding, and no assessment of withdrawal severity. |
| 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 |
Dropout 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 control groups drawn from same population. |
| Other bias: Comparability of cohorts |
Low risk |
No significant differences in demographics of two groups. |
| Other bias: Representativeness of exposed cohort |
Low risk |
Participants drawn from patients admitted to substance abuse detoxification unit. |
| Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |
