Opiate Dependent Clinical Trial
Official title:
Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01560442 -
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine
|
N/A |