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A double-blind, randomized, parallel group study to compare the efficacy, safety and tolerability of slow-release oral morphine versus methadone in opioid-dependent in-patients willing to undergo detoxification



This article is corrected by:

  1. Errata: Erratum Volume 104, Issue 11, 1947, Article first published online: 9 October 2009

Ekkehard Madlung-Kratzer, Psychiatric Hospital, Thurnfeldgasse 14, A-6060 Hall / Tyrol, Austria.
E-mail: ekkehard.madlung-kratzer@tilak.at


Aims  Evaluation of the efficacy and safety of slow-release oral morphine (SROM) compared with methadone for detoxification from methadone and SROM maintenance treatment.

Design  Randomized, double-blind, double-dummy, comparative multi-centre study with parallel groups.

Setting  Three psychiatric hospitals in Austria specializing in in-patient detoxification.

Participants  Male and female opioid dependents (age > 18 years) willing to undergo detoxification from maintenance therapy in order to reach abstinence.

Interventions  Abstinence was reached from maintenance treatment by tapered dose reduction of either SROM or methadone over a period of 16 days.

Measurements  Efficacy analyses were based on the number of patients per treatment group completing the study, as well as on the control of signs and symptoms of withdrawal [measured using Short Opioid Withdrawal Scale (SOWS)] and suppression of opiate craving. In addition, self-reported somatic and psychic symptoms (measured using Symptom Checklist SCL-90-R) were monitored.

Findings  Of the 208 patients enrolled into the study, 202 were eligible for analysis (SROM: n = 102, methadone: n = 100). Completion rates were 51% in the SROM group and 49% in the methadone group [difference between groups: 2%; 95% confidence interval (CI): −12% to 16%]. The rate of discontinuation in the study was high mainly because of patients voluntarily withdrawing from treatment. No statistically significant differences between treatment groups were found in terms of signs and symptoms of opiate withdrawal, craving for opiates or self-reported symptoms. SROM and methadone were both well tolerated.

Conclusions  Detoxification from maintenance treatment with tapered dose reduction of SROM is non-inferior to methadone.