title: 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.
abstract: OBJECTIVE
  Evaluation of the efficacy and safety of slow-release oral morphine (SROM) compared with methadone for detoxification from methadone and SROM maintenance treatment.
  
  
  METHODS
  Randomized, double-blind, double-dummy, comparative multi-centre study with parallel groups.
  
  
  METHODS
  Three psychiatric hospitals in Austria specializing in in-patient detoxification.
  
  
  METHODS
  Male and female opioid dependents (age > 18 years) willing to undergo detoxification from maintenance therapy in order to reach abstinence.
  
  
  METHODS
  Abstinence was reached from maintenance treatment by tapered dose reduction of either SROM or methadone over a period of 16 days.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
authors.affiliation: Psychiatric Hospital,Thurnfeldgasse 14, A-6060 Hall, Tyrol, Austria. ekkehard.madlung-kratzer@tilak.at
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Madlung-Kratzer
authors.forename: Bernhard
authors.initials: B
authors.lastname: Spitzer
authors.forename: Berhard
authors.initials: B
authors.lastname: Spitzer
authors.forename: Renate
authors.initials: R
authors.lastname: Brosch
authors.forename: Dirk
authors.initials: D
authors.lastname: Dunkel
authors.forename: Christian
authors.initials: C
authors.lastname: Haring
mesh_terms: D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008691:Methadone / Q000008:administration & dosage*; D009020:Morphine / Q000008:administration & dosage*; D009294:Narcotics / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D009294:Narcotics; D009020:Morphine; D008691:Methadone
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