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Study on Ketamine to Prevent Relapse in Patients with Opioid Use Disorder

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 Use Disorder (OUD), a condition where individuals have a strong desire to use opioids, despite the negative effects on their health and life. The study is exploring the use of Ketamine, a medication that is typically used for pain relief and anesthesia, to see if it can help prevent relapse in people who are trying to stop using opioids. The main goal is to find out if Ketamine can help people stay off opioids for longer periods, reduce their cravings, and improve their mood during recovery.

Participants in the study will receive Ketamine through an intravenous infusion, which means it will be given directly into a vein. The study will last for a period of up to six weeks. During this time, researchers will monitor the participants to see how Ketamine affects their ability to stay abstinent from opioids, as well as any changes in their cravings and mood. The study also aims to identify certain biological markers, known as biomarkers, that might predict when someone is at risk of relapsing.

By understanding how Ketamine works in the context of opioid addiction treatment, the study hopes to provide new insights into how to better support individuals with OUD. This could lead to improved treatment options that help people maintain their recovery and improve their overall well-being. The study is part of ongoing efforts to find effective ways to combat opioid addiction and support those affected by it.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    An initial assessment is conducted to confirm eligibility for the study. This includes verifying age between 18 to 65 years, acceptance into maintenance care for opioid or heroin use disorder, a score of 10 or more on the PHQ-9 (indicating depression symptoms), and retention in opioid use treatment.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to assess current health status and establish initial measurements. This may include psychological assessments and physical examinations.

  3. Step 3

    Ketamine administration

    The medication ketamine is administered through an intravenous infusion. The dosage, frequency, and duration of administration are determined by the study protocol and are designed to evaluate the potential of ketamine as a complementary treatment for opioid addiction.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring and follow-up sessions are conducted to assess the effects of ketamine on prolonging abstinence, reducing cravings, and reversing negative affective behaviors. This includes tracking changes in mood, cravings, and overall mental health.

  5. Step 5

    Biomarker identification

    The study aims to identify biomarkers that predict vulnerability to relapse. This involves evaluating emotion regulation ability, stress response biomarkers, and changes in neural activity.

  6. Step 6

    Final evaluation

    A final evaluation is conducted to assess the overall outcomes of the treatment. This includes measuring the association between ketamine-induced changes in brain activity and treatment outcomes.

Who can join the trial?

4 criteria

  • Must be between 18 to 65 years old.
  • Must be accepted into a program for ongoing care to treat **opioid** or **heroin use disorder**. This means you are receiving regular treatment to help with opioid or heroin addiction.
  • Must have a score of 10 or more points on the **PHQ-9**. This is a questionnaire that helps identify symptoms of **depression**.
  • Must continue to be involved in treatment for **opioid use**. This means you are actively participating in a program to help manage opioid addiction.

Who cannot join the trial?

9 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who do not have a diagnosis of Opioid Use Disorder, which means they do not have a pattern of opioid use that causes significant problems or distress.
  • Individuals who are part of a vulnerable population, which refers to groups that may have a higher risk of harm or exploitation in research settings.
  • Individuals who are not able to comply with the study procedures or follow-up requirements.
  • Individuals who have medical conditions or are taking medications that could interfere with the study or pose a risk to their health.
  • Individuals who are pregnant or breastfeeding, as the study may pose risks to the mother or child.
  • Individuals who have a history of severe mental health disorders that are not stable or controlled, as this could affect their ability to participate safely in the study.
  • Individuals who have a history of allergic reactions to the study medication or similar drugs.
  • Individuals who are currently participating in another clinical trial, as this could interfere with the results of the study.
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Investigated drugs

Ketamine is being studied for its potential to help people with opioid-use disorders. Researchers are looking at whether it can help prevent relapse by prolonging the time someone stays off opioids, reducing cravings, and lowering the chances of returning to opioid use after a period of abstinence.

What is already known about the treatment

Ketamine – Ketamine is administered intravenously or intramuscularly and is currently being studied for its potential use in treating opioid use disorder. It is primarily known as an anesthetic and has been used in medical settings for pain relief and sedation. In recent studies, ketamine is being evaluated for its ability to help prevent relapse in individuals recovering from opioid addiction. The mechanism of action involves blocking NMDA receptors in the brain, which may help reduce cravings and prolong abstinence. Ketamine is classified as a dissociative anesthetic, and its potential use in opioid addiction treatment is an area of active research.

Investigated diseases

Opioid Use Disorder – This condition is characterized by a problematic pattern of opioid use that leads to significant impairment or distress. Individuals with this disorder often experience strong cravings for opioids and may continue using them despite harmful consequences. Over time, they may develop a tolerance, requiring larger amounts to achieve the same effect, and experience withdrawal symptoms when not using the drug. The disorder can lead to changes in brain function, affecting decision-making, behavior, and emotional regulation. It often involves cycles of relapse and remission, with periods of abstinence followed by a return to opioid use. The disorder can significantly impact an individual's social, occupational, and personal life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520843-34-00Protocol codeEXCELLENCE/0421/0543Estimated enrolment20 patientsSponsorUniversity of Cyprus

sourced from the EU Clinical Trials Register and site verification

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