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

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What is this study about?

This clinical trial is focused on studying a condition known as Gamma-Hydroxybutyrate (GHB) use disorder, which involves the excessive use of a substance called GHB. The study aims to explore whether adding a medication called baclofen can help reduce the need for pharmaceutical GHB during the detoxification process for patients with this disorder. Baclofen is available in tablet form, with doses of 10 mg and 25 mg, and is taken orally. Another medication involved in the study is sodium oxybate, which is an oral solution.

The purpose of the study is to determine if baclofen can effectively assist in the detoxification process for patients with GHB use disorder. Participants in the study will receive either baclofen or a placebo, and their progress will be monitored to see if there is a reduction in the need for pharmaceutical GHB. The study will take place over a period of time, with regular assessments to track the effects of the treatment.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how well the treatment works. The ultimate goal is to find a more effective way to support individuals undergoing detoxification from GHB use disorder, potentially improving their recovery process and overall health outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include being diagnosed with GHB use disorder according to established guidelines, requiring inpatient detoxification, using more than 50ml of GHB per day, and being over 18 years old.

2 initial assessment

An initial assessment is conducted to understand the current health status and GHB usage patterns. This involves a series of questions and possibly some medical tests to ensure safety and suitability for the trial.

3 treatment phase

During the treatment phase, the main objective is to reduce the need for pharmaceutical GHB. This is achieved by adding baclofen to the treatment regimen.

The medications used include Baclofen Mylan 10 mg tablets, Baclofen Mylan 25 mg tablets, and Xyrem 500 mg/mL oral solution. These are administered orally, following a specific dosage and frequency as determined by the healthcare team.

4 monitoring and adjustments

Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and make any necessary adjustments. This includes tracking the dosage of pharmaceutical GHB required and observing any changes in health or symptoms.

5 end of treatment evaluation

At the end of the treatment phase, an evaluation is performed to determine the final dosage of pharmaceutical GHB needed. This helps in understanding the impact of the baclofen add-on therapy.

Who Can Join the Study?

Must be diagnosed with GHB use disorder (GUD) according to the DSM-V-TR criteria. The DSM-V-TR is a manual used by healthcare professionals to diagnose mental disorders.
Must need inpatient treatment for GHB detoxification. This means you need to stay in a hospital or clinic to safely stop using GHB.
Must use more than 50ml of GHB per day.
Must be over 18 years old.

Who Cannot Join the Study?

Patients who are not diagnosed with GHB use disorder cannot participate. GHB use disorder is a condition where a person has a problematic pattern of using a substance called GHB.
Patients who are not within the specified age range for the study cannot participate. The study is for adults only.
Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
Patients who are not willing or able to comply with the study procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Sqmnnnzbt Rglpcqw Unpmsrastr Mmcbvel Csnchg	Nijmegen	The Netherlands
Nqxyiqnnshtgiow	Vught	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Baclofen is a medication that is being tested in this clinical trial to see if it can help people who are trying to stop using GHB, a substance that can be addictive. Baclofen is usually used to treat muscle spasms, but in this study, it is being used to see if it can reduce the need for GHB during the detoxification process. The goal is to find out if adding baclofen to the treatment plan can make it easier for patients to go through detoxification by lessening their cravings or withdrawal symptoms.

Investigated diseases:

Drug use disorder

Gamma-Hydroxybutyrate Use Disorder – Gamma-Hydroxybutyrate Use Disorder is a condition characterized by the compulsive use of gamma-hydroxybutyrate (GHB), a central nervous system depressant. Individuals with this disorder experience a strong desire to consume GHB, often leading to increased tolerance and withdrawal symptoms when not using the substance. The disorder progresses as the individual becomes increasingly dependent on GHB, which can lead to significant impairment in daily functioning. Over time, the person may require larger doses to achieve the same effects, and attempts to reduce or stop use can result in withdrawal symptoms. These symptoms can include anxiety, tremors, sweating, and insomnia. The disorder can severely impact social, occupational, and other important areas of functioning.

Trial ID:

2023-506167-34-02

Protocol code:

PaNaMa ID: 114633

Trial Phase:

Therapeutic exploratory (Phase II)

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