Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)

Brief Summary

Detailed Description

The objective of this study is to compare the effectiveness of slow-release oral morphine (SROM) treatment in patients that previously have been treated with methadone. Efficacy is assessed by the frequency of by-consumption of illicit substances. 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 SROM treatment in a crossover design. The secondary endpoints are: 1. The effects of SROM on retention rate. 2. By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines). 3. Occurring psychopathological and somatic symptoms. 4. Effect of treatment on the ECG (QTc prolongation). 5. Group characterisation of patients that is keen to change the medication. 6. The change in dosage of treatment over time. 7. Self-assessed craving for Opioids. 8. Self-assessed satisfaction with treatment. 9. Nature, frequency and severity of occurring adverse events in the two treatment groups. 10. Assessment of safety parameters. Study Design (Methodology): This is a multicentre, multinational phase III study. It is conducted using a randomised, open label cross-over design. The subjects will be randomised to either 10 weeks of treatment with methadone or SROM. After an adjustment phase of one week they first will be medicated for 10 weeks with the treatment to which SUB9001 - Integrated Study Protocol 9/58 June 13, 2009 they have been randomised. The cross-over, in which all subjects change to their opposite treatment, will serve for an additional adjustment phase of one week. After the second and new adjustment phase they are treated for 10 weeks with the newly adjusted medication. After the end of week 22 all participants continue with or switch back to SROM for another 6 month (week 23 to 47).

Primary Outcomes

Secondary Outcomes

• Secondary Outcome Measures(throughout the 22 week cross over period)
• By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines)(throughout the 22 week cross over period)
• Occurring psychopathological and somatic symptoms.(througout the 22 week cross over period)
• Effect of treatment on the ECG (QTc prolongation)(throughout the 22 week cross over phase)
• Group characterisation of patients that is keen to change the medication(throughout the 22 week cross over period)
• The change in dosage of treatment over time(throughout the 22 week cross over period)
• Self-assessed craving for Opioids(throughout the 22 week cross over period)
• Self-assessed satisfaction with treatment.(throughout the 22 week cross over period)
• Nature, frequency and severity of occurring adverse events in the two treatment groups(throughout the 22 week cross over period)
• Assessment of safety parameters(throughout the 22 week cross over period)