Patients with an opioid or multiple substance dependence (including opioids), actually enrolled in a methadone maintenance therapy in one of the study centres (ICD classifications F11.22, F19.22). MedDRA version: 9.1 Level: LLT Classification code 10052970 Term: Drug withdrawal maintenance therapy MedDRA version: 9.1 Level: HLT Classification code 10052730 Term: Drug withdrawal therapies MedDRA version: 9.1 Level: HLGT Classification code 10043413 Term: Therapeutic procedures and supportive c
Conditions
Interventions
Trade Name: Mundidol® UNO retard Kapseln 60 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: MORPHINE SULFATE
CAS Number: 64313
Other descriptive name: MORPHINE SULFATE
Concentration unit: mg mil
Sponsors
Mundipharma Medical Company, Basel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Minimum age: 18 years • Fixed abode • At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or = 25 mg/day levomethadone at inclusion. Patients on levomethadone must be informed and agree to be switched to methadone • Mature and capable of acting responsibly, in possession of all mental faculties • Contraception (non-hormonal, hormonal) by women of child-bearing age • No intention of reducing the substitute medication during the trial • Acceptance of the trials rules and regulations • Acceptance to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • (Desired) pregnancy during the trial • Grave or acute somatic illnesses (e.g. cardio-vascular, serious kidney or liver affection (ALAT or ASAT > 5x augmented)) or other somatic disorder • If suffering from severe unstable mental health problems • If MAO-Inhibitors or are being taken • Known hypersensitivity to Morphine • Paralytic ileus • Baseline QTc interval greater than 450 msec • Long QT Syndrome • Patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry • Patients with pending imprisonment at the time of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with Methadone. Efficacy is assessed by the frequency of by-use of illicit substances. ;Secondary Objective: • the effects of slow release oral morphine on retention rate • the effects of slow release oral morphine on adverse drug effects typical for methadone, e.g. sweating, obstipation, xerostomia • the changes in craving • the changes in self assessed contentedness • the changes in psychopathological and somatic symptoms between the treatment groups over the treatment time in the respective periods of the cross over design • the effects of slow release oral morphine on the ECG (QT prolongation) • the change in dosage of treatment over time;Primary end point(s): The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject. Target substances are defined as all opioids except the study drug. The proportions are compared between substitution with Methadone and slow release oral morphine treatment in a cross-over design. | — |
Countries
Germany
Outcome results
None listed