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Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.
EU CTIS ID: 2024-519652-90-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.