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Clinical Trials/EUCTR2007-001216-23-AT
EUCTR2007-001216-23-AT
Active, not recruiting
Not Applicable

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

Phoenux AG0 sitesJune 1, 2007
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ConditionsOpiate addictionMedDRA version: 9.1Level: LLTClassification code 10019935Term: Heroin addiction
DrugsVendal AmpullenSubstitol retardNaloxon Ratiopharm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opiate addiction
Sponsor
Phoenux AG
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 1, 2007
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Phoenux AG

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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