Opioid dependence: Opioid dependence is a serious and usually chronic disease that requires treatment, encompasses various psychological and physical dimensions, and is associated with concomitant diseases and increased mortality. MedDRA version: 26.1 Level: LLT Classification code 10013658 Term: Drug addiction System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Hydagelan
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Hydromorphone hydrochloride
CAS Number: 71-68-1
Concentration unit: mg/ml milligram(s)/millilitre
Concen
Sponsors
Suchthilfe Wien gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 20 and 65 years - Opioid dependence according to ICD-10 diagnostic criteria. - Patient has been on opioid agonist therapy (OAT) for at least one year; otherwise has been on intravenous opioid use for at least one year; - Patients inject at least 5 times per week. - Presence of a consumption pattern that corresponds with the opening hours of the Suchthilfe Wien - Patient demonstrates willingness and ability to adhere to the planned study procedure and schedule. - Signed patient information after informed consent has been given - no planned vacations (more than 1 day per week), surgeries, hospital or prison stays within the next 14 weeks 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 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Diagnosis of severe medical or psychiatric illnesses - Pregnancy - Evidence of severe comorbidities with a predicted life expectancy of less than 12 months - Hypersensitivity to hydromorphone or any of the following other ingredients: Sodium chloride, sodium citrate, citric acid monohydrate, water for injections. - Presence of the following contraindications: o severe respiratory depression with hypoxia or elevated carbon dioxide levels in the blood (hypercapnia). o severe chronic obstructive airway disease o Cor pulmonale o Acute abdomen o Paralytic ileus o concomitant administration of monoaminooxidase inhibitors or within 2 weeks of their discontinuation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to determine whether - intravenous opioid agonist therapy with hydromorphone can be integrated into clinical practice and is safe in this therapeutic setting. - to include further target groups that have not yet been reached or have been reached only poorly. - the offer of intravenous OAT is accepted by patients and staff of the Suchthilfe Vienna gGmbH. - the intravenous consumption of "illegal" opioids or opioid-containing medications prescribed for oral use is reduced. - the general state of health (somatic/psychological) and the social situation stabilize. - a decrease in delinquency is recorded. - a higher retention rate in treatment can be achieved. ;Secondary Objective: The secondary objectives of the study are to develop a patient-centered care model and to further develop psychosocial services for this patient group.;Primary end point(s): Primary study endpoints - Reduction of intravenous opioid use outside the medical setting. - Feasibility of implementation and execution ;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study endpoints - Reduction in co-drug use - Safety of the intervention - Improvement in health status - Retention in treatment;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Countries
Austria
Contacts
Public ContactMedical Director
Suchthilfe Wien gGmbH
Outcome results
None listed