Not recruiting

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

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying opioid dependence, a serious and often long-lasting condition that affects both the mind and body. The trial will use a treatment called Hydagelan, which contains the active ingredient hydromorphone hydrochloride. This medication is given through an injection into a vein. The purpose of the study is to see if this treatment can be safely used in a clinical setting and if it can help people who are dependent on opioids.

Participants in the study will receive the treatment over a period of up to 12 weeks. The study aims to find out if the treatment can be successfully integrated into regular medical practice and if it is accepted by both patients and healthcare staff. It will also look at whether the treatment can help reduce the use of illegal opioids or other opioid medications that are meant to be taken by mouth. Additionally, the study will assess if the treatment can improve the overall health and social situation of the participants, and if it can help them stay in treatment longer.

The trial will also monitor the safety of the treatment and its impact on reducing the use of other drugs. By the end of the study, researchers hope to gather information on how well the treatment works and whether it can be a viable option for people struggling with opioid dependence. The study is being conducted in Vienna and is expected to conclude by the end of 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 20 and 65 years, confirming opioid dependence, and ensuring a history of opioid agonist therapy or intravenous opioid use for at least one year.
The assessment also checks the frequency of injections, which should be at least 5 times per week, and ensures the consumption pattern aligns with the opening hours of the study site.
Participants must demonstrate willingness and ability to adhere to the study schedule and procedures.
Step 2
Informed consent
Participants are provided with detailed information about the study. After understanding the information, participants are required to sign a consent form to confirm their voluntary participation.
Step 3
Treatment administration
Participants receive hydromorphone hydrochloride as a solution for injection/infusion. The product is administered via intravenous injection.
The available concentrations of the solution are 10 mg/ml, 20 mg/ml, and 50 mg/ml. The specific dosage and frequency are determined based on individual needs and medical guidance.
Step 4
Monitoring and evaluation
Throughout the study, participants are regularly monitored to assess the safety and feasibility of the treatment.
The primary focus is on reducing intravenous opioid use outside the medical setting and evaluating the feasibility of the treatment implementation.
Secondary evaluations include monitoring for reduction in co-drug use, safety of the intervention, improvement in health status, and retention in treatment.
Step 5
Completion and follow-up
The study is estimated to conclude by November 30, 2025. Upon completion, participants may undergo a final assessment to evaluate the overall impact of the treatment.
Follow-up procedures may be conducted to ensure the continued well-being of participants and to gather additional data on the long-term effects of the treatment.

Who can join the trial?

9 criteria

Age between 20 and 65 years.
Have opioid dependence according to ICD-10 diagnostic criteria. This means the person has a recognized pattern of opioid use that affects their health and life.
Have been on opioid agonist therapy (OAT) for at least one year. OAT is a treatment that uses medications to help manage opioid dependence.
If not on OAT, have been using opioids intravenously for at least one year.
Inject opioids at least 5 times per week.
Have a pattern of opioid use that matches the opening hours of the Suchthilfe Wien, a support service.
Show willingness and ability to follow the study procedures and schedule.
Sign the patient information form after giving informed consent, which means understanding and agreeing to participate in the study.
No planned vacations (more than 1 day per week), surgeries, hospital stays, or prison stays within the next 14 weeks.

Who cannot join the trial?

5 criteria

Patients who are not dependent on opioids. Opioid dependence means having a strong need to use opioid drugs regularly, which can affect both the mind and body.
Patients who are not within the specified age range for the study.
Patients who do not belong to the clinical trial groups specified for the study.
Patients who are not part of the vulnerable population selected for the study.
Patients who do not meet other specific criteria set by the study organizers.

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Investigated drugs

Hydagelan: This is a medication used in the trial as an intravenous opioid agonist therapy. It contains hydromorphone hydrochloride, which is a type of opioid. The purpose of using this medication in the trial is to see if it can be safely integrated into clinical practice for treating patients who need opioid therapy. The trial aims to determine if this treatment can help reduce the use of illegal opioids, improve the overall health and social situation of the patients, and increase the likelihood that patients will stay in treatment.

HYDROMORPHONE HYDROCHLORIDE

What is already known about the treatment

Hydromorphone Hydrochloride – This medication is administered intravenously and is currently being studied for its safety and feasibility in treating opioid dependence. It is an opioid agonist therapy, which means it works by binding to opioid receptors in the brain to reduce withdrawal symptoms and cravings associated with opioid dependence. Hydromorphone is classified as an opioid analgesic and is typically used for pain management, but in this study, it is being evaluated for its potential to stabilize the health and social situation of individuals with opioid dependence. The goal is to integrate this therapy into clinical practice and assess its acceptance among patients and healthcare providers.

Investigated diseases

Opioid Dependence – Opioid dependence is a chronic condition characterized by a strong desire to use opioids, difficulties in controlling their use, and continued use despite harmful consequences. It involves both physical and psychological components, where the body adapts to the presence of the drug, leading to withdrawal symptoms when not taken. Over time, individuals may require higher doses to achieve the same effect, a phenomenon known as tolerance. This condition often coexists with other health issues and can significantly impact a person's social and emotional well-being. The progression of opioid dependence can lead to a cycle of compulsive drug-seeking behavior and use, despite negative outcomes.