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

AimsEvaluation of the efficacy and safety of slow-release oral morphine (SROM) compared with methadone for detoxification from methadone and SROM maintenance treatment.DesignRandomized, double-blind, double-dummy, comparative multi-centre study with parallel groups.SettingThree psychiatric hospitals in Austria specializing in in-patient detoxification.ParticipantsMale and female opioid dependents (age > 18 years) willing to undergo detoxification from maintenance therapy in order to reach abstinence.InterventionsAbstinence was reached from maintenance treatment by tapered dose reduction of either SROM or methadone over a period of 16 days.MeasurementsEfficacy 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.FindingsOf 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.ConclusionsDetoxification from maintenance treatment with tapered dose reduction of SROM is non-inferior to methadone.

Novel opioid detoxification using loperamide and P‐glycoprotein inhibitor

“…[24][25][26][27][28][29][30][31] This study addressed the safety of loperamide over a short period of time and during the study development no serious adverse events were reported. Despite differences in study design, this finding is comparable with other treatment approaches used for opioid detoxification 17,18,32,33 and, when considered together with the finding that no instances were reported of additional requests for either medication, suggests that this protocol is not only safe, but also well-tolerated. This potentially places it within reach of those unable to access other medically supervised detoxification programs due to barriers outlined earlier, including inpatient, outpatient and primary health care settings.…”

Pharmacological strategies for detoxification

“…However, Madlung‐Kratzer et al . have shown it has a similar effectiveness to methadone in a double‐blind parallel group study of tapering over 16 days, a conclusion also supported by a recent systematic review . It may be suitable for users who do not want or cannot tolerate methadone or buprenorphine.…”

Slow‐release oral morphine for opioid maintenance treatment: a systematic review

“…A recent randomized controlled trial investigated SROM efficacy for opioid detoxification [40]. No statistically significant differences were found between SROM and methadone in terms of completion rate (proportion of patients completing the study), signs and symptoms of opioid withdrawal, craving for opioid or self‐reported symptoms.…”