Treatment of opioid dependence
Conditions
Interventions
Product Name: Morphine- Naloxone
Product Code: Morphine-Naloxone
Pharmaceutical Form: Solution for injection
CAS Number: 51481-60-8
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Concentrat
Sponsors
G. L. Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male, over the age of 18 years - meet DSM-IV criteria for the diagnosis of opioid dependence currently undergoing morphine mainteinance treatment, - with a history of regular opioid abuse, - under opioid maintenance treatment for opioid abuse with morphine (occasionally injecting heroin) with a constant dose for = 1 month, - in good health and have venous access sufficient for i.v. drug administration - with assessed normal QTc time (Bazzett corrected =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - with clinically significant somatic illnesses (except stable chronic hepatitis), - with acute psychotic illnesses, i.e. known schizophrenia, major depression with suicidal intent, - with opioid maintenance treatment with morphine at variable doses or for a period of 100 g during the last 4 weeks, - with cocaine dependence, - showing contraindications to morphine (known hypersensitivity to opioids, restricted respiratory function, serious impairment of liver and/or kidney function, inter alia), - uncooperative patients, unwilling to follow instructions by the Investigator, - patients scheduled for any major surgery or intervention, which would fall within the study period, - patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry, - patients 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, - with imprisonment or under criminal prosecution for the following 4 week-period, - with incapacitation and court appointment. - with documented (ultrasound or right heart catheter) heart failure (NYHA >II) - with documented (ECG) history of cardiac arrhythmia
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pupil diameter and vital signs at various time points. ;Timepoint(s) of evaluation of this end point: 0 to 120 minutes | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the appropriate ratio of morphine and naloxone to suppress the pleasurable effects of intravenous morphine and precipitate withdrawal reactions. ;Secondary Objective: Assessment of individual physiological variables and symptoms and vital signs during study drug administration at various time points. Assessment of safety including adverse events, clinical laboratory results and vital signs. ;Primary end point(s): Signs and symptoms of opioid-withdrawal at various time points.;Timepoint(s) of evaluation of this end point: 0 to 120 minutes | — |
Countries
Austria
Contacts
Public ContactG. L. Pharma GmbH
G. L. Pharma GmbH
Outcome results
None listed