Subjects have a diagnosis of opiate addiction.
Conditions
Interventions
Trade Name: MXL capsules 60 mg
Product Name: MXL capsules 60 mg
Product Code: Morphine sulphate prolonged release capsules
Pharmaceutical Form: Prolonged-release capsule*
INN or Proposed INN: Morphine
Sponsors
Napp Pharmaceuticals Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/female, subjects aged over 18 years, with a fixed abode and due to remain in the locality of their investigator site for at least the next 3 months. 2. Subjects with a primary diagnosis of heroin addiction (positive for Substance Dependence as per DSM-IV-TR). Subjects with poly drug use in addition to heroin addiction will be allowed to enter but these must be documented in the subject’s source notes and CRF. 3. Subjects seeking a new episode of opioid maintenance therapy. Subjects who have previously failed on opioid maintenance therapy (for example buprenorphine, morphine, methadone, etc.) would not be precluded from entering the study. 4. Subjects who give written informed consent to participate in the study. 5. Subjects who agree to interim substitution (12 weeks approximately) with morphine sulphate prolonged release capsules or methadone oral solution. 6. Subjects whom the investigator considers to be willing and able to fulfil study requirements by study clinical investigator(s). 7. Subjects whose General practitioners (GPs) have been informed where possible of their participation in the study, if they agree to the GPs being informed. 8. Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998. 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: 1. Any subject who already has a stable response to a structured treatment programme in the last month using either of the test articles, buprenorphine or other licensed products for substitution/maintenance therapy. 2. Subjects who have experienced multiple substitution therapy failure, i.e. six or more. 3. Subjects with any clinically significant major organ system disease (such as relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major system diseases) making implementation of the protocol or interpretation of the results difficult. 4. Subjects with currently active psychiatric conditions (e.g. schizophrenia) which, in the opinion of the investigator, would make them unsuitable to participate in the study. 5. Subjects scheduled to undergo planned inpatient procedures/admissions for medical, surgical or psychiatric conditions during the titration and treatment periods. 6. Subjects with alcohol dependency, in whom the investigator feels this may compromise the subject’s safety or ability to participate in the study (negative for Substance Dependence - as per DSM-IV-TR). 7. Subjects who are pregnant or lactating or who are intending to become pregnant within the next 10 months from study entry. Subjects who are of childbearing potential must agree to have pregnancy tests at baseline and at the end of the study, and will be encouraged to use contraception. 8. Subjects with any contraindications to methadone or morphine as outlined in Section 4.3 of the Summary of Product Characteristics (SmPC) or in the investigator brochure. 9. A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms). 10. Subjects with a history of additional risk factors for QT interval prolongation or torsades de pointes (TdP). In addition, subjects with any of the following will be excluded: History of cardiac conduction abnormalities. Advanced heart disease or ischaemic heart disease, heart failure. Liver disease, family history of sudden death, family history of Long QT Syndrome. Electrolyte abnormalities, e.g. hypokalaemia, hypomagnesaemia 11. Subjects who have participated in a clinical research study involving a new chemical entity or experimental drug within 30 days of study entry (defined as the start of the screening period). 12. Subjects who, in the opinion of the investigator, are unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The per protocol population and full analysis population will be used to summarise and analyse the following: Percentage of subjects failing urine drug screen for illicit heroin use – The number and percentage of subjects in each treatment group that fail the urine drug screen will be summarized by treatment group and visit. The number of subjects who fail the urine drug screen on at least one occasion during the treatment period will be analysed using the chi-square test. If possible, the number of occasions that the subject fails the urine screen during the treatment period will be summarised and a comparison made between the two treatment groups. Where subjects in the full analysis population have failed to provide a urine sample when requested, it will be assumed that the missed urine sample was positive for illicit heroin.;Main Objective: The objective of this study is the reduction of illicit heroin use after treatment with morphine sulphate prolonged release capsules compared with methadone treatment. Evidence for illicit heroin use will be obtained from urine analysis.;Secondary Objective: The retention rate at the end of the maintenance treatment period % of subjects reporting on top use of illicit heroin during the treatment period % of subjects reporting on top use of other drugs of abuse during the treatment period % of subjects failing the urine drug screen for other drugs of abuse during the treatment period % of subjects failing to achieve optimum maintenance dose % of subjects changing the dose of study drug during the maintenance period The average maintenance dose required SF-36 v2 questionnaire Beck Depression Inventory II Subject satisfaction with their drug therapy % of subjects with injection sites/fresh puncture wounds/self-report of frequency of injection during the treatment period % of subjects reporting criminal offences during the treatment period reported change in use of other drugs during the treatment period Vis | — |
Countries
United Kingdom
Outcome results
None listed