Phase I Studie bei substituirten chronischen Opiatgebrauchern zur Aufhebung zusätzlicher Opioidwirkungen einer weiteren Opiatgebrauchern zur Aufhebung zusätlicher Opioidwirkungen einer weiteren Opiatdosis durch Gabe des Antagonisten Naloxon - Gobo - 2

Active, not recruiting

Conditions: Opiate addiction
MedDRA version: 9.1Level: LLTClassification code 10019935Term: Heroin addiction

Registration Number: EUCTR2007-001216-23-AT

Lead Sponsor: Phoenux AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Male

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures