Overview
Sponsor-declared trial summary
GHB use disorder
To assess whether the baclofen add-on therapy reduces the need for pharmaceutical GHB during inpatient detoxification in patients with GUD
Key facts
- Sponsor
- Stichting Radboud University Medical Center
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 16 Jun 2025 → ongoing
- Decision date (initial)
- 2023-12-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response, Therapy, Safety
To assess whether the baclofen add-on therapy reduces the need for pharmaceutical GHB during inpatient detoxification in patients with GUD
Conditions and MedDRA coding
GHB use disorder
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506167-34-01 | Improving inpatient GHB detoxification with baclofen: A proof of concept and dose-finding study. | Stichting Radboud University Medical Center |
| 2023-506167-34-00 | Improving inpatient GHB detoxification with baclofen: A proof of concept and dose-finding study. | Stichting Radboud University Medical Center |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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
Exclusion criteria 8
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The main study parameter is pharmaceutical GHB dosage at the end of the titration phase during inpatient detoxification in patients with GUD
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Baclofen Mylan 25 mg, tabletten
PRD10072094 · Product
- Active substance
- Baclofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- M03BX01 — BACLOFEN
- Marketing authorisation
- RVG 12154
- MA holder
- MYLAN B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Baclofen Mylan 10 mg, tabletten
PRD10072093 · Product
- Active substance
- Baclofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- M03BX01 — BACLOFEN
- Marketing authorisation
- RVG 12153
- MA holder
- MYLAN B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
PRD6368662 · Product
- Active substance
- Sodium Oxybate
- Substance synonyms
- SODIUM SALT OF GAMMA-HYDROXYBUTYRIC ACID, OXYBATE SODIUM, SODIUM OXYBUTYRATE, SODIUM 4-HYDROXYBUTYRATE
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 200 ml millilitre(s)
- Max total dose
- 99999999 ml millilitre(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N07XX04 — -
- Marketing authorisation
- EU/1/05/312/001
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud University Medical Center
- Sponsor organisation
- Stichting Radboud University Medical Center
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Drs. Amber Wood
Public contact point
- Organisation
- Stichting Radboud University Medical Center
- Contact name
- Drs. Amber Wood
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 28 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-06-16 | 2025-06-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-13 | Netherlands | Acceptable 2023-12-14
|
2023-12-14 |