#1 Clinical Trials Search in Europe

HYDROMORPHONE HYDROCHLORIDE

Clinical trials investigating HYDROMORPHONE HYDROCHLORIDE are studying intravenous opioid agonist therapy in people with opioid dependence. This article summarizes what the trial aimed to test, who it enrolled, the phase, and the main outcomes, such as safety, feasibility, and reduced outside opioid use.

Table of contents

Trial overview

The trial titled “Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna” studied HYDROMORPHONE HYDROCHLORIDE in a real-world treatment setting.[1] It was completed and enrolled 30 people.[1]

This was an interventional study, which means the research team gave a treatment and then measured the results.[1]

Who was studied

The trial focused on people with opioid dependence, a serious and usually long-lasting condition that affects physical health, mental health, and social life.[1] The study also aimed to include further target groups that had not yet been reached well, or had been reached only poorly, by existing treatment services.[1]

The trial was carried out with the goal of making treatment more accessible for patients who may not have benefited enough from other options.[1]

What was tested

The study tested intravenous opioid agonist therapy (OAT) using Hydagelan® (hydromorphone hydrochloride) in Vienna.[1] “Intravenous” means the medicine was given into a vein.[1]

The trial looked at whether this approach could be built into clinical practice and whether it was safe in this treatment setting.[1] It also checked whether patients and staff at Suchthilfe Vienna gGmbH accepted the offer of this treatment.[1]

Main outcomes and what they mean

The primary outcome was the reduction of intravenous opioid use outside the medical setting.[1] In simple terms, the study wanted to see whether treatment could lower opioid use that happens outside supervised care.[1]

The trial also measured feasibility of implementation and execution, which means whether the treatment could be started and run successfully in practice.[1]

Other goals included checking whether the general state of health, both physical and psychological, became more stable, whether the social situation improved, whether delinquency decreased, and whether more people stayed in treatment.[1]

Study design and phase

This was a Phase 2 trial.[1] Phase 2 studies usually explore whether a treatment may help and continue to watch for safety and practical use.[1]

The study was a pilot project, which means it was a small early study meant to test the idea before larger research.[1]

Why this trial matters

This trial is important because it looked beyond medicine alone and focused on real-life treatment use, patient acceptance, and social outcomes.[1] It aimed to see whether HYDROMORPHONE HYDROCHLORIDE could help reduce unsafe opioid use and support better stability in people with opioid dependence.[1]

Because the study was completed, its results can help explain whether this approach is practical for treatment programs in similar settings.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519652-90-01 Phase 2 Opioid dependence Completed 30

FAQ

  • What is being studied in the HYDROMORPHONE HYDROCHLORIDE trial? The trial studied intravenous opioid agonist therapy using HYDROMORPHONE HYDROCHLORIDE. It focused on whether this treatment could be used in real clinical practice and whether it was safe in that setting.
  • Who could take part in this trial? The trial targeted people with opioid dependence. It also aimed to include further target groups that had not yet been reached well by treatment services.
  • What phase was the trial? This was a Phase 2 trial. Phase 2 studies usually look at early signs of benefit and continue to check safety and how well the treatment can be used.
  • What outcomes did the trial measure? The main outcomes were reduction of intravenous opioid use outside the medical setting and whether the treatment could be implemented and carried out in practice. The study also looked at health, social stability, delinquency, and retention in treatment.
  • Was the trial completed? Yes, the trial status was completed. That means the study had finished collecting the planned information.

Ongoing Clinical Trials on HYDROMORPHONE HYDROCHLORIDE

  • Study on the Safety and Feasibility of Intravenous Hydromorphone Hydrochloride for Patients with Opioid Dependence

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria

Glossary

  • Opioid dependence: A long-term condition where a person has a strong need to use opioids. It can affect both the body and mind and is often linked with other health and social problems.
  • Intravenous: Given into a vein. This is a fast way to deliver a treatment directly into the bloodstream.
  • Opioid agonist therapy (OAT): A treatment approach that uses an opioid medicine in a controlled medical setting to help manage opioid dependence.
  • Phase 2: A trial stage that looks at early effectiveness and continues to study safety and how practical the treatment is.
  • Feasibility: Whether a treatment or study can be carried out successfully in real life.
  • Retention in treatment: How well people stay in the treatment program over time.
  • Delinquency: Illegal or harmful behavior. In this trial, it was one of the social outcomes being tracked.
  • Somatic health: Physical health of the body.
  • Psychological health: Mental and emotional health.
  • Interventional study: A study where researchers give a treatment and then measure what happens.

References

  1. https://clinicaltrials.gov/study/2024-519652-90-01