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]
- Decision date (initial)
- 2023-10-12
- 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: Therapy, Efficacy, Safety, Dose response
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
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 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
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
Auxiliary 1
SCP26800314 · ATC
- Active substance
- Sodium Oxybate
- Substance synonyms
- SODIUM SALT OF GAMMA-HYDROXYBUTYRIC ACID, OXYBATE SODIUM, SODIUM OXYBUTYRATE, SODIUM 4-HYDROXYBUTYRATE
- Route of administration
- ORAL
- Max daily dose
- 800 g gram(s)
- Max total dose
- 800 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07XX04 — SODIUM OXYBATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Gamma-hydroxybutyric acid 150mg/ml instead of 500mg/ml to allow titration and tapering during inpatient GHB detoxification
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 | Not authorised | 28 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-07 | Netherlands | Not acceptable 2023-10-09
|
2023-10-12 |