Authorised Therapeutic exploratory (Phase II) GHB use disorder

Improving inpatient GHB detoxification with baclofen

EU CTIS ID: 2023-506167-34-02

What this study is testing

To assess whether the baclofen add-on therapy reduces the need for pharmaceutical GHB during inpatient detoxification in patients with GUD

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Diagnosed with GUD according to the DSM-V-TR criteria of substance use disorder
  • Indication for intramural GHB detoxification
  • GHB use >50ml/day
  • >18 years old

You likely can't join if

  • Patients who has acute psychiatric co-morbidity that require immediate medical attention and interferes with the execution of the study, such as mania, delirium and psychosis
  • Physical contra-indications for baclofen
  • Body weight <55kg
  • Insufficient understanding of the Dutch language
  • GHB use >120ml/day
  • Comorbid benzodiazepine use >30mg diazepam equivalent per day
See the full eligibility criteria
Who can join
  • Diagnosed with GUD according to the DSM-V-TR criteria of substance use disorder
  • Indication for intramural GHB detoxification
  • GHB use >50ml/day
  • >18 years old
What rules you out
  • Patients who has acute psychiatric co-morbidity that require immediate medical attention and interferes with the execution of the study, such as mania, delirium and psychosis
  • Physical contra-indications for baclofen
  • Body weight <55kg
  • Insufficient understanding of the Dutch language
  • GHB use >120ml/day
  • Comorbid benzodiazepine use >30mg diazepam equivalent per day
  • Use of antihypertensive drugs
  • Use of tricyclic antidepressant drugs

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.