Vilalta 1987.
Methods | Randomised, controlled, double‐blind trial | |
Participants | Setting: inpatient, hospital, Barcelona, Spain. Participants: 32 heroin users, admitted for treatment of organic disease (mainly infectious disease related to consumption of drugs). Group sizes: (1) n = 14, (2) n = 8, (3) n = 10. Mean age: 23 years. 65% men. |
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Interventions | (1) Methadone, 30 mg/day. (2) Clonidine, 10 μg/kg/day. (3) Levomepromazine (neuroleptic) 75 mg/day. Doses of all drugs increased until stable, maintained 3 days, then tapered. Treatment scheduled for around 8 days |
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Outcomes | Mean opioid withdrawal score; mean score of secondary effects; mean score of adjustment to hospital setting; number completing treatment | |
Notes | Ratings of withdrawal (24 items), side effects (19 items), attitudes and disruptive behaviour during hospitalisation (11 items) daily by single observer. Urine screening used. Source of funding not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation by random numbers table |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) Subjective outcomes ‐ intensity of withdrawal, adverse effects | Low risk | Double‐blind stated |
Blinding (performance bias and detection bias) Objective outcomes ‐ duration of treatment, completion of treatment | Low risk | Double‐blind stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Difference in drop‐out rates insufficient to distort reported outcomes |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |