A randomised, double blind, double-dummy, parallel group study to compare the efficacy and tolerability of morphine sulphate prolonged release capsules and methadone oral solution in once per day administration for agonist maintenance treatment of opiate addiction. - SUB3001

Conditions: Subjects have a diagnosis of opiate addiction.

Registration Number: EUCTR2005-004482-41-GB

Lead Sponsor: app Pharmaceuticals Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.