| Methods |
Randomised controlled trial. Not all participants had entered treatment voluntarily. Setting: inpatient treatment in 5 different rehabilitation centres. |
| Participants |
200 heroin users, dependent by DSM‐III‐R. 100 allocated to each group. (1) 73% (2) 82% male. (1) 80 (2) 67 using orally only, others iv or iv and oral.
Men age (1) 24.9 (2) 24.7. No previous treatments (1) 79% (2) 63%. Duration of addiction (1) 16.1 (2) 15.2 months. At admission time since last drug intake (1) 8.7 hours(2) 10.7. No demographics differences. Excl. cr.: concurrent medical condition, infectious diseases, mental illnesses. |
| Interventions |
(1) Methadone, max days 1‐2 then tapered and ceased after day 12; mean max dose day 2 = 21.6 mg.
(2) Clonidine, "sufficient" dose days 1‐4, tapered days 5‐8, ceased after day 11; mean max dose day 2 = 1.05 mg.
For both drugs initial dose dependent on body weight, physical condition, heroin intake previous week. Dose titrated against withdrawal and side effects. Scheduled duration of the study: 12 days. Country of origin: China |
| Outcomes |
Acceptability of the treatment as mean daily withdrawal score and as total scores of undesirable side effects. Other: score variation in Hamilton Anxiety test. No drop outs reported. Endpoint of naloxone challenge used for only half of participants. |
| Notes |
Report in Chinese, English translation obtained. Symptoms and vital signs assessed daily using Himmelsbach scale as guide; 21 designated symptoms and vital signs also assessed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
method not reported |
| Allocation concealment (selection bias) |
Unclear risk |
method of allocation not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
no information on blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
no information on blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
results on all randomised participants |
