| Methods |
Random allocation by researcher. Groups similar on demographics and drug use history except recent amphetamine use (higher in antagonist‐induced withdrawal group). Intention to treat analysis. Higher dropout from standard detoxification group. Observers and treating clinician post‐detoxification blind to group allocation. |
| Participants |
101 heroin users, 94% injectors, dependent by DSM‐IV. Group sizes (1) 51 (2) 50. 60% male. Mean age 31 years. Mean 10 years heroin use. 77% single. 48% unemployed. Inpatient treatment in (1) intensive care unit of general hospital, and substance use clinic if required, (2) substance use clinic only. |
| Interventions |
(1) Naloxone, 4 or 5 boluses to 10 or 12 mg, under propofol anaesthesia. Intubated, spontaneous ventilation. Duration of anaesthesia about 4 hours. Range of adjunct medications. (2) Clonidine and symptomatic medications. Both groups given 400ug naloxone challenge (1) after recovery from anaesthesia (2) after at least 3 days. If no significant response, given 50mg naltrexone. Aftercare naltrexone (50mg/day) and supportive counselling. |
| Outcomes |
Number completing treatment; number commencing naltrexone; days between admission and naltrexone induction; number experiencing adverse events; number abstinent at follow‐up by self‐report and hair analysis. |
| Notes |
Withdrawal assessed by Subjective and Objective Opiate Withdrawal Scales, and modified Objective Opiate Withdrawal Scale during anaesthesia. Country: Australia |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "Randomisation was carried out in blocks of four...". Random numbers table used. |
| Allocation concealment? |
Low risk |
Quote: "Randomisation was carried out ... by a member of the research team blind to participants' identity or history." |
| Blinding?
Subjective outcomes ‐ intensity of withdrawal, adverse effects |
Unclear risk |
Participants and staff of detoxification unit aware of treatment. Medical officer providing follow‐up naltrexone maintenance treatment and research staff blinded to group allocation, but adequacy of blinding uncertain. |
| Blinding?
Objective outcomes ‐ duration of treatment, completion of treatment |
Low risk |
These outcomes considered unlikely to be affected by awareness of treatment group. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
Retention in treatment, and completion of treatment primary outcome measures. Significant differences in dropout rates for two groups resulted in data on severity of withdrawal being at risk of bias, but these data not used. |
| 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 |
Groups similar on demographics. |
| Other bias: Representativeness of exposed cohort |
Low risk |
Participants drawn from general opioid‐dependent population wishing to undergo detoxification. |
| Other bias: Ascertainment of exposure |
Low risk |
Data collection established by study protocol. |
