AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy of Ketamine for the Prevention of Relapse in Patients with Opioid-Use Disorders (OUD)

This research study is exploring if ketamine, a type of medicine, can help individuals who are recovering from opioid use disorder (addiction) to reduce their cravings and stay abstinent (off opioids). The study also aims to see if ketamine can improve mood and general well-being, which can be challenging during recovery. This is an early stage (Phase II) clinical trial, meaning researchers are looking at its effectiveness and safety in a smaller group of people. They also hope to find ways to predict who might benefit most from this treatment by looking at things like brain activity and how people manage emotions.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University of Cyprus

Enrolment target

Start

29 Jan 2025

Opioid Use Disorder

What is this study about?

Opioid use disorder is a complex condition where a person becomes dependent on strong painkillers like codeine, morphine, or heroin. This dependence can lead to serious health problems and can be very challenging to overcome.

This study is investigating a new approach using ketamine. Ketamine is a medicine that's been used in healthcare for a long time, usually for anaesthesia or pain relief. However, more recently, researchers have been looking at its potential for other conditions, including mental health issues and addiction. The main goal of this study is to see if ketamine can help people with opioid use disorder to stay off opioids for longer periods and reduce the intense cravings often associated with recovery. It also aims to see if ketamine can help with difficult emotions, like feeling low or anxious, which are common during recovery.

Beyond just seeing if ketamine helps, the researchers also want to understand *how* it helps. They will be looking for special signals in the body and brain – called 'biomarkers' – that might show who is more likely to benefit from ketamine. This could include how people handle emotions, their body's response to stress, and changes in brain activity. By understanding these signals, doctors might be able to offer more personalised and effective treatments in the future.

Key takeaways

This study explores ketamine for opioid use disorder.
It aims to reduce cravings and help people stay off opioids.
Researchers also want to improve mood and emotional well-being.
It's an early-stage trial looking for effectiveness and safety.
The study seeks to find 'biomarkers' to predict who benefits most.

Who may be eligible?

This study is for adults aged 18 and over. It's open to everyone, regardless of gender. You would be considered if you have been diagnosed with opioid use disorder. To be eligible, you would likely need to meet specific health criteria, which the study team would discuss with you in detail. For example, they would check your medical history to make sure ketamine would be safe for you and won't interfere with other medicines you might be taking.

The research team will make sure you understand the study fully before you decide if you wish to take part. This process ensures the study is safe for all involved and that the results are as accurate as possible.

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?
Have you been diagnosed with opioid use disorder?
Are you able to attend regular study appointments?
Are you willing to potentially take a new medication (ketamine) as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, ketamine, as part of the trial. The exact way you receive the medication and how often would be explained to you by the study team. You would also have regular visits to the study clinic for assessments. These assessments might include talking about your feelings and cravings, answering questionnaires, and potentially having some tests to look at how your body is responding to the treatment, such as checking stress levels or brain activity. The study team will track your progress over time, and you'll have follow-up appointments to monitor your well-being. The total length of your participation in the study would be clearly outlined before you start.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as a new approach to help manage opioid cravings and stay abstinent, and possibly fewer difficult emotions. However, as with any medical trial, there may be risks and side effects associated with ketamine, which the study team will explain in full detail. You might experience temporary changes in your mood, perception, or other physical effects. It's important to remember that you are free 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
Cyprus

Common questions

What is opioid use disorder?

It's when someone becomes dependent on opioid medications or drugs like heroin, struggling to stop using them despite wanting to.

What is ketamine?

Ketamine is a medicine often used for pain relief or anaesthesia, but researchers are also looking at its effects on mental health and addiction.

Is this a new treatment?

Using ketamine specifically for opioid use disorder is being tested in this study. It's not yet a standard treatment for this condition.

Will I definitely get ketamine?

If you join the study, you would receive ketamine as the intervention being tested. However, they may also compare it to other existing or placebo treatments.

What does a 'Phase II' study mean?

Phase II means it's an early-stage study looking at how well a treatment works and its safety in a smaller group of people, after initial safety tests.