Opiate addiction MedDRA version: 9.1 Level: LLT Classification code 10019935 Term: Heroin addiction
Conditions
Interventions
Trade Name: Vendal Ampullen
Product Name: Vendal Amp 200 mg
Pharmaceutical Form: Intravenous infusion
Trade Name: Substitol retard
Product Name: Substitol retard
Pharmaceutical Form: Tablet
Trade Na
Sponsors
Phoenux AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Persons being capable of understanding the objective of the study and the related measures • Persons participating in the trial on a totally voluntary bases • Male Patients • Age between 25 and 35 years • Opiate substitution patients, taking 600 mg per day of morphine as substitution treatment • Patients being opiate dependent for at least 3 years 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Not enabled to provide written informed consent before beginning any study related activities or placed under guardianship • Relevant co consummation of drugs or alcohol 2 weeks before start of the study • Acute corporal illness • Kidney or liver insufficiency • Anaemia (HB <13 g/dl) • Recurrent intake of medications other than substitution medication • Known hypersensitity to Morphine or Naloxone • Coloured or bleached hair /head, axial or pubic • Participating in any other studies involving investigational products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dosage of Naloxone necessary to stop the effects of a dosage of morphine with opiate addicted patients ;Secondary Objective: Safety and Tolerance of Sustained Release Morphine and Naloxone with opiate used and addicted patients;Primary end point(s): Dosage in mg of Naloxon which effectively blocks 200mg Morphine in opiate addicted patients | — |
Countries
Austria
Outcome results
None listed