RANDOMISED, CONTROLLED CLINICAL STUDY REGARDING THE FEASIBILITY OFCONVERTING OPIATE DEPENDENTS FROM METHADONE SUBSTITUTES TO SLOWRELEASE MORPHINE SULPHATE (SEVRE-LONG®)

• Conditions: 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: 9.1Level: LLTClassification code 10052970Term: Drug withdrawal maintenance therapy; MedDRA version: 9.1Level: HLTClassification code 10052730Term: Drug withdrawal therapies; MedDRA version: 9.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NEC; MedDRA version: 9.1Level: LLTClassification code 10012346Term: Dependence on opiates; MedDRA version: 9.1Level: LLTClassification code 10013663Term: Drug dependence; MedDRA version: 9.1Level: HLTClassification code 10064465Term: Substance-related disorders; MedDRA version: 9.1Level: HLGTClassification code 10037176Term: Psychiatric disorders NEC

• Registration Number: EUCTR2008-002185-60-DE
• Lead Sponsor: Mundipharma Medical Company, Basel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-11
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

• (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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified