Overview
Sponsor-declared trial summary
Benzodiazepine dependence (F13.2)
The primary aim of the study is to test whether there is a difference between daily intranasal administration of oxytocin or placebo for 21 days added to a dose reduction regime of diazepam in benzodiazepine withdrawal symptoms. Benzodiazepine withdrawal symptoms severity is measured with CIWA-B score, a 20-item scale …
Key facts
- Sponsor
- St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Decision date (initial)
- 2024-11-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516262-11-00
- EudraCT number
- 2019-002280-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary aim of the study is to test whether there is a difference between daily intranasal administration of oxytocin or placebo for 21 days added to a dose reduction regime of diazepam in benzodiazepine withdrawal symptoms. Benzodiazepine withdrawal symptoms severity is measured with CIWA-B score, a 20-item scale where each item can be assigned a score from 0 to 4, i.e. the total score can range from 0 and 80 points. CIWA-B score will be measured daily from baseline (i.e. the day before the intervention starts) to day 21. Change in CIWA-B from baseline to day 21 will compared between the two groups.
Secondary objectives 1
- The secondary aims are to test whether there is a difference between oxytocin and placebo on cravings (measured daily with a 6-item Likert scale where the score can range between 0 to 5 points between the two study groups from baseline to day 21), on rebound anxiety and depression symptoms (comparing HAD scores measured weekly from baseline to day 21), on sleep (assessed by actigraphy and Somnofy), number of "freezes" in diazepam tapering (number of times not reducing the diazepam dosage as scheduled).
Conditions and MedDRA coding
Benzodiazepine dependence (F13.2)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients aged 18 – 65 years, taking BZDs at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient BZD withdrawal. Included patients must consent to participate in the study.
Exclusion criteria 1
- Female patients will be excluded if they are pregnant or are planning to become so, or if they are breast-feeding. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Patients with concurrent acute medical or psychiatric illness requiring acute care hospitalization, misuse or dependency of alcohol or pregabalin/gabapentin will be excluded.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of the study is measuring BZD withdrawal symptoms to see if OT administered intranasally in addition to traditional dose tapering is more effective than BZD tapering and placebo. CIWA-B is a well-known and well-used 20-item questionnaire for BZD withdrawal symptoms where each item can be assigned a score from 0 to 4, i.e. the total score can range between 0-80 points. Based on previous studies a 3.5-point difference is considered clinically relevant.
Secondary endpoints 1
- Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
OXYTOCIN CD PHARMA 6,7 mikrog/dose nesespray, oppløsning
PRD11340883 · Product
- Active substance
- Oxytocin
- Substance synonyms
- GR121619
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 48 IU international unit(s)
- Max total dose
- 1008 IU international unit(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- 4115
- MA holder
- CD PHARMACEUTICALS AB
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Syntocinon 40 IE/ml neusspray, oplossing
PRD5383601 · Product
- Active substance
- Oxytocin
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 48 IU international unit(s)
- Max total dose
- 1008 IU international unit(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- RVG 03716
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid Fresenius Kabi 9 mg/ml infusjonsvæske, oppløsning
PRD2128245 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 300 ml millilitre(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 5846
- MA holder
- FRESENIUS KABI NORGE AS OSLO
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- Prinsesse Kristinas G. 3
- City
- Trondheim
- Postcode
- 7030
- Country
- Norway
Scientific contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Tone Aurora Pleym
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Tone Aurora Pleym
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D11_Protocol EU CT 2024-416262-11-00 | 3.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_Subject information and informed consent form EU CT 2024-416262-11-00 | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC oxytocin | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Norway | Acceptable 2024-11-07
|
2024-11-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Norway | Acceptable 2025-02-25
|
2025-02-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-14 | Norway | Acceptable 2025-02-25
|
2026-04-14 |