Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.

This study, happening in Vienna, is exploring a new way to help people who are dependent on opioids. Opioid dependence is a serious, long-term health condition that affects both the mind and body, and can lead to other health problems. The study is testing a medication called Hydagelan, given directly into a vein (through a drip), to see if it's safe and if it can be practically used in a treatment setting. The main goal is to see if this treatment helps people use fewer illegal opioids. Researchers are also looking at whether it helps reduce the use of other drugs, improves overall health, and encourages people to stay in treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Suchthilfe Wien gGmbH

Enrolment target

Start

17 Feb 2025

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.

What is this study about?

This study is about finding better ways to help people who are struggling with opioid dependence. Opioid dependence is a very serious health condition where a person relies on opioids, which can be prescription pain relievers or illegal drugs like heroin. It's not just a physical problem; it affects a person's thoughts, feelings, and overall life. People living with opioid dependence often face other health issues and sadly, it can even shorten lives.

The study is testing a new form of treatment called opioid agonist therapy (OAT) using a medication called Hydagelan. This medication is given directly into a vein, like you might have a drip in a hospital. The medical team wants to find out if giving Hydagelan this way is a safe and practical option for people. They are hoping it will help people reduce how often they use illegal opioids.

Beyond just reducing illegal opioid use, the study also aims to see if this treatment helps people cut down on other drugs, improves their general health and wellbeing, and encourages them to stay in their treatment programme. This type of research, called a Phase II study, is an early step in testing new treatments to make sure they are safe and could be helpful for patients.

Key takeaways

The study is testing a new treatment called Hydagelan for opioid dependence.
It's exploring if giving Hydagelan through a drip is safe and practical.
A main goal is to help people reduce their use of illegal opioids.
The study will also look at overall health improvements and treatment retention.
It's an early-stage study, meaning more research will be needed in the future.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

More specific details about who can join will be provided by the study team. For example, they will need to check your medical history to make sure the treatment is suitable and safe for you.

It's important to discuss your full medical background and any medications you are currently taking with the study doctor to see if you are a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man or a woman?
Do you have opioid dependence?
Are you willing to receive medication through an intravenous drip?
Can you commit to regular clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to make sure the treatment is right for you. The main part of the treatment involves receiving the study medication, Hydagelan, directly into a vein (like a drip). The strength of the medication will be one of three options: 50 mg/ml, 10 mg/ml, or 20 mg/ml solution. The research team will regularly check your health and how you are responding to the treatment. They will also keep track of your opioid use and any other drug use. This involves regular visits to the clinic for assessments and to receive your treatment. The total duration of the study, including how long you would receive treatment and how long they will follow up with you afterwards, would be fully explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit of this study is that the Hydagelan treatment might help reduce your use of illegal opioids and potentially improve your overall health. However, like all medications given intravenously, there could be risks such as side effects from the drug, or issues related to having a drip, like discomfort or infection at the injection site. The research team will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is opioid dependence?

Opioid dependence is a serious health condition where a person's body and mind rely on opioids, affecting their health and daily life.

What is Hydagelan?

Hydagelan is a medication being tested in this study as a treatment for opioid dependence, given through a drip.

What does 'intravenous' mean?

Intravenous means the medication is given directly into a vein, usually through a small tube or drip.

Will this study help me stop using drugs completely?

This study aims to help reduce the use of illegal opioids and improve health, but it's part of a broader treatment approach.

Can I leave the study at any time?

Yes, you have the right to leave the study at any point without it affecting your usual medical care.