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Study on Baclofen for Inpatient Detoxification in Patients with GHB Use Disorder

Verified siteRegistered 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 a condition known as GHB use disorder, which involves the excessive use of a substance called gamma-hydroxybutyric acid (GHB). The study aims to explore the effectiveness of a medication called baclofen in helping patients reduce their need for pharmaceutical GHB during detoxification. Baclofen is a medication that is typically used to treat muscle spasms, and in this study, it is being tested to see if it can assist in the detoxification process for individuals with GHB use disorder.

Participants in the study will receive either baclofen or a placebo, in addition to the standard treatment for GHB detoxification. The study will involve taking baclofen in tablet form, with doses of either 10 mg or 25 mg. The treatment period will last for a short duration, and the progress of the participants will be monitored to determine if baclofen helps in reducing the need for GHB during the detoxification process.

The purpose of this study is to assess whether adding baclofen to the treatment plan can make the detoxification process more effective for patients with GHB use disorder. By understanding the potential benefits of baclofen in this context, the study aims to improve treatment options for individuals undergoing detoxification from GHB. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable information on the effectiveness of the treatment.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including a diagnosis of GHB use disorder, a need for inpatient detoxification, and a daily GHB use of more than 50 ml. Participants must be over 18 years old.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility and gather baseline health information. This step ensures that the participant meets all necessary criteria for the study.

  3. Step 3

    Treatment phase

    Participants receive oral medication as part of the treatment. This includes baclofen in tablet form, available in 25 mg and 10 mg doses, and sodium oxybate. The specific dosage and frequency are determined based on individual needs and study protocols.

    The main goal is to assess whether adding baclofen reduces the need for pharmaceutical GHB during detoxification.

  4. Step 4

    Monitoring and adjustments

    Throughout the treatment, participants are closely monitored. Adjustments to medication dosages may be made based on the participant's response and any side effects experienced.

    The primary focus is on the dosage of pharmaceutical GHB at the end of the titration phase.

  5. Step 5

    Completion of treatment

    The treatment phase concludes once the objectives of the study are met or at the end of the designated study period.

    Participants may undergo final assessments to evaluate the outcomes of the treatment.

Who can join the trial?

4 criteria

  • Must have a diagnosis of **GHB use disorder (GUD)**. This means a doctor has determined that the person has a problem with using GHB, a substance that can be addictive.
  • Must need **inpatient GHB detoxification**. This means the person needs to stay in a medical facility to safely stop using GHB.
  • Must use more than **50ml of GHB per day**. This is a measure of how much GHB the person is using daily.
  • Must be **over 18 years old**. This means the person must be an adult.

Who cannot join the trial?

7 criteria

  • Patients who do not have a **GHB use disorder**. GHB is a substance that can be misused, and this study is for those who have issues with its use.
  • Patients who are not within the specified age range for the study. The study has a specific age group it is focusing on.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • Patients who are currently participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of severe allergic reactions to the study medication or similar drugs.
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Investigated drugs

Baclofen is a medication being studied to see if it can help reduce the need for pharmaceutical GHB during inpatient detoxification for patients with GHB use disorder (GUD). It is being used as an add-on therapy, which means it is given in addition to the standard treatment to see if it can improve the detoxification process.

What is already known about the treatment

Baclofen – Baclofen is administered orally in tablet form and is currently being studied for its potential use in treating GHB use disorder. It is primarily used as a muscle relaxant and antispastic agent, but recent studies are exploring its effectiveness in reducing the need for pharmaceutical GHB during detoxification. Baclofen works by activating GABA-B receptors in the brain, which helps to decrease neuronal excitability and may alleviate withdrawal symptoms. It is classified as a centrally acting skeletal muscle relaxant.

Investigated diseases

Gamma-Hydroxybutyrate Use Disorder – This condition involves the problematic use of gamma-hydroxybutyrate (GHB), a substance that can lead to dependence and addiction. Individuals with this disorder may experience a strong desire to consume GHB, difficulties in controlling its use, and continued use despite harmful consequences. Over time, the body may develop a tolerance, requiring larger amounts to achieve the same effects. Withdrawal symptoms can occur if the substance is not taken, which may include anxiety, tremors, and insomnia. The disorder can significantly impact daily life, affecting personal, social, and occupational functioning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506167-34-00Protocol codePaNaMa ID: 114633Estimated enrolment28 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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