Umbricht 2003.
| Methods | Randomised controlled trial with stratification on withdrawal severity, pain, cocaine use, CD4 cell count. Groups similar except (1) more likely to have been admitted for fever/cellulitis | |
| Participants | Setting: inpatient treatment, AIDS service, Baltimore, USA. Participants: 55 HIV‐positive, opioid‐dependent by self report and physical examination, hospitalised for acute medical illness. Group sizes: (1) n = 21 (not considered for this review), (2) n = 16, (3) n = 18. (1) 71% (2) 69% (3) 44% men. Mean age (± SD): 39.7 ± 5.6. Duration of heroin use: about 18 years. Concurrent alcohol dependence, enrolment in methadone maintenance treatment both exclusion criteria. 95% to 100% African‐American |
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| Interventions | All stabilised with morphine 10 mg im every 4 hours as needed up to 6 hours prior to enrolment in study. 3‐day taper with: (1) Buprenorphine 0.6 mg im every 4 hours day 1, every 6 hours day 2, every 8 hours day 3. (2) Clonidine, oral 0.2 mg loading dose, 0.1 mg every 4 hours day 1, every 6 hours day 2, every 8 hours day 3. (3) Methadone, oral 30 mg day 1, 20 mg day 2, 10 mg day 3. All received clonidine transdermal patch day 4. No adjunct treatment for withdrawal. Scheduled duration 3 days |
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| Outcomes | Withdrawal severity; completion rate; adverse effects; use of supplemental morphine for pain | |
| Notes | Withdrawal assessed by Short Opiate Withdrawal Scale (participants) and Objective Opiate Withdrawal Scale (observers). Supported by National Institute on Drug Abuse Intramural Research Program | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "... patients were randomly assigned ..." "... patients were stratified on four characteristics ..." Comment: Method of sequence generation not specifically reported but with stratification on 4 characteristics is likely to be computer based |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation not reported |
| Blinding (performance bias and detection bias) Subjective outcomes ‐ intensity of withdrawal, adverse effects | Low risk | Quote: "To maintain the blind, one active medication and two inactive medications were administered to all participants." |
| Blinding (performance bias and detection bias) Objective outcomes ‐ duration of treatment, completion of treatment | Low risk | Double‐blind stated, placebos used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out was related to the acute medical condition that was the reason for hospital admission and was unlikely to introduce bias to outcome assessments. Statistical methods allowed for missing data and variation in time of assessment |
| Selective reporting (reporting bias) | Low risk | None apparent |
| Other bias | Low risk | None apparent |