Methods |
Randomised controlled trial. Setting: outpatient treatment; component of multi‐centre study. |
Participants |
49 opiate addicts >‐ 6 mo. receiving methadone 20 mg/day or less, (1) 25 (2) 24, 76% males, mean age 29.5 Y., mean length of addiction 10.0 Y. Groups similar. |
Interventions |
(1) Methadone, initial dose 20 mg/day, single daily oral dose tapered by 1 mg/day.
(2) Clonidine oral, initial dose 0.3 mg/day in 3 divided doses; by day 6, gradual increase to max 1 mg/day; from day 11, tapered by 20‐25% per day. Chloral hydrate as adjunct medication. Scheduled duration of the study 30 days. Country of origin: USA. |
Outcomes |
Completion rate as number of drop‐outs and percentages of success rates. Acceptability of the treatment as mean withdrawal scores at baseline and weeks 1‐2‐3‐4; rates of withdrawal symptoms (graph), comparison of withdrawal characteristics of success and failure in the two groups, incidence and characteristics of side effects and number using sleep medication. Results at follow‐up at 1, 3, 6 months as naloxone challenge rates. Other: Scores of Beck Depression inventory and of ASI. |
Notes |
Withdrawal rated by nurses (24 items, 0‐3 severity) and participants (31 items, 1‐4 severity). Side effects rated by physicians and nurses. Successful detoxification, the main outcome, was defined as a) having 10 days following the last dose of study methadone in which no illicit opiate use is reported, or b) passing a naloxone test. |
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 |
Low risk |
participants and staff blind to treatment, blind maintained with placebo |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
stated as blind |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
ITT analysis |