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.
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.
Madlung-Kratzer
Ekkehard
E
Psychiatric Hospital,Thurnfeldgasse 14, A-6060 Hall, Tyrol, Austria. ekkehard.madlung-kratzer@tilak.at
Spitzer
Bernhard
B
Spitzer
Berhard
B
Brosch
Renate
R
Dunkel
Dirk
D
Haring
Christian
C
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
D003692:Delayed-Action Preparations; D009294:Narcotics; D009020:Morphine; D008691:Methadone
Addiction. 2005 Aug;100(8):1035
16042623
NIDA Res Monogr. 1982 Apr;41:239-45
6811915
Subst Use Misuse. 1997 May;32(6):779-92
9178443
Addict Behav. 1987;12(1):1-6
3565107
Addiction. 1998 Apr;93(4):515-32
9684390
Addiction. 2004 Aug;99(8):940-5
15265090
Addict Behav. 1990;15(6):541-7
2075851
Wien Klin Wochenschr. 2002 Nov 30;114(21-22):904-10
12528322
Lancet. 1996 Jan 13;347(8994):97-100
8538351
Addiction. 2008 Nov;103(11):1837-46
19032534
J Pain Symptom Manage. 2005 Jan;29(1):80-90
15652441
Am J Psychiatry. 2008 Feb;165(2):179-87
18198270
Br Med J (Clin Res Ed). 1986 Jul 12;293(6539):103-4
3089407
Neurosci Biobehav Rev. 1997 Jan;21(1):91-104
8994212
BMJ. 1994 Oct 15;309(6960):997-1001
7950725
Drug Alcohol Depend. 2008 Apr 1;94(1-3):151-7
18155364
Curr Opin Psychiatry. 2006 May;19(3):266-70
16612211
Drug Alcohol Depend. 2001 Oct 1;64(2):173-80
11543987
Can J Psychiatry. 2006 Sep;51(10):635-46
17052031
Br J Addict. 1992 Jan;87(1):55-62
1311974
Addiction. 1999 Feb;94(2):231-9
10396791
Eur Addict Res. 2006;12(2):53-60
16543739
Arch Intern Med. 2004 Feb 9;164(3):277-88
14769623
Br J Addict. 1991 Aug;86(8):977-82
1912752
J Psychopharmacol. 2008 Jun;22(4):409-16
18635721
Addiction. 2005 Aug;100(8):1101-9
16042640