Clinical trial • Phase II • Psychiatry
OXYTOCIN for Benzodiazepine dependence
Phase II trial of OXYTOCIN for Benzodiazepine dependence.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Benzodiazepine dependence
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 07-11-2024
Trial design
Randomised, placebo: natriumklorid fresenius kabi 9 mg/ml solution for intranasal use (placebo) administered daily for 21 days; both study groups receive a diazepam dose reduction (taper) regimen as background treatment.-controlled Phase II trial across 1 site in Norway.
- Randomised
- Yes
- Comparator
- Placebo: Natriumklorid Fresenius Kabi 9 mg/ml solution for intranasal use (placebo) administered daily for 21 days; both study groups receive a diazepam dose reduction (taper) regimen as background treatment.
- Target Sample Size
- 60
- Trial Duration For Participant
- 21
Eligibility
Recruits 60 Vulnerable populations selected. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Participants must provide informed consent prior to enrolment..
- Pregnancy Exclusion
- Female patients will be excluded if they are pregnant or are planning to become so, or if they are breast-feeding.
- Vulnerable Population
- Vulnerable populations selected. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Participants must provide informed consent prior to enrolment.
Inclusion criteria
- {"criterion_text":"- 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
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"CIWA-B score measured daily from baseline (the day before intervention starts) to day 21; primary outcome is change in CIWA-B from baseline to day 21. A 3.5-point difference is considered clinically relevant."}
Secondary endpoints
- {"endpoint_text":"- Hamilton Anxiety and Depression Scale (HAD), Insomnia Severity Index (ISI) and actigraphy and Somnofy assessed akathisia and sleep.","definition_or_measurement_approach":"HAD scores measured weekly from baseline to day 21; ISI and objective sleep measures assessed by actigraphy and Somnofy; akathisia and sleep outcomes assessed via actigraphy/Somnofy and ISI as applicable."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent is required from participants. Individuals incapable of giving informed consent are excluded. A subject information and informed consent form is listed among study documents; no details on assent or languages provided in the available data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Norway
- Earliest CTIS Part Ii Submission Date
- 28-10-2024
- Latest Decision Or Authorization Date
- 07-11-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Blue Cross, Clinic Lade
- Department Name
- Department of detoxification
- Contact Person Name
- Tone Aurora Pleym
- Contact Person Email
- post@ladebs.no
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- St. Olavs Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- OXYTOCIN CD PHARMA 6,7 mikrog/dose nesespray, oppløsning
- Active Substance
- OXYTOCIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRANASAL USE
- Route
- INTRANASAL USE
- Authorisation Status
- Authorised
- Frequency
- Daily for 21 days
- Maximum Dose
- 48 IU
- Investigational Product Name
- Syntocinon 40 IE/ml neusspray, oplossing
- Active Substance
- OXYTOCIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRANASAL USE
- Route
- INTRANASAL USE
- Authorisation Status
- Authorised
- Frequency
- Daily for 21 days
- Maximum Dose
- 48 IU
- Investigational Product Name
- Natriumklorid Fresenius Kabi 9 mg/ml infusjonsvæske, oppløsning
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRANASAL USE
- Route
- INTRANASAL USE
- Authorisation Status
- Authorised
- Frequency
- Daily for 21 days
- Maximum Dose
- 10 ml
- Combination Treatment
- Yes
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