[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574302":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":66,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":32,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":32,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants in the placebo arm will receive a saline solution. Saline is an inert substance, meaning it has no therapeutic effect, making it an ideal placebo. The saline solution will be administered in the same manner as the experimental treatment. The treatment is administered intranasally. The treatment is blinded. Neither the participants nor the researchers know who is receiving the placebo and who is receiving the active treatment. Participants in the placebo arm will be monitored the same as those in the treatment arm. Participants will be fully informed about the possibility of receiving a placebo and will provide informed consent. The same outcome measures will be used for both the placebo and treatment arms.",[13],"Drug: Saline (NaCl 0,9 %) (placebo)",{"label":15,"type":16,"description":17,"interventionNames":18},"Oxytocin","EXPERIMENTAL","Participants in this arm will receive intranasal oxytocin. The dosage and administration schedule will be consistent with the study protocol. Participants will receive 48 international units (IU) of oxytocin. The oxytocin will be administered intranasally using a nasal spray. Participants will insert the nasal spray container approximately 1 cm into each nostril and spray. They will wait 15 seconds before repeating administration until they have received a total of 4 puffs (2 in each nostril) per session thrice daily.",[19],"Drug: Oxytocin nasal spray",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oxytocin nasal spray","Syntocinon contains synthetic oxytocinfor intranasal use, 6.7 microg (4 IU) per dose. We are planning to use 4 insufflations (16 IU) three times daily (i.e. a total daily dose of 48 IU).",[15],[27],"Syntocinon",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Saline (NaCl 0,9 %) (placebo)","Saline intranasal placebo comparator",[9],null,[34],{"name":35,"affiliation":36,"role":37},"Tone Aurora Pleym, MD, PhD-candidate","NTNU, Blue Cross, Clinic Lade, St. Olavs hospital","STUDY_CHAIR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","+47 97 62 55 83","tone.pleym@ntnu.no",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Olav Spigset MD, Professor of Clinical Pharmacology","+47 725 73 000","olav.spigset@legemidler.no",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Blue Cross, Clinic Lade","RECRUITING","Trondheim","Trøndelag","7091","Norway","NO",{"type":57,"coordinates":58},"Point",[59,60],10.39506,63.43049,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":65,"phoneExt":32,"email":42},"Tone Aurora Pleym MD, PhD-candidate","+47 97625583",{"type":67,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[69,71],{"name":70,"class":6},"Norwegian University of Science and Technology",{"name":72,"class":73},"Lade Behandlingssenter, Blå Kors","UNKNOWN","100574302","phase-2-effects-of-intranasal-oxytocin-in-the-treatment-of-benzodiazepine-withdrawal-a-pilot-rct-100574302",false,"NCT06757517","Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT","Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallell Group Placebo-Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 - 65 years, taking benzodiazepines at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient benzodiazepine withdrawal. Included patients must consent to participate in the study.\n\nExclusion Criteria:\n\n* 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\u002Fgabapentin will be excluded.","ALL","18 Years","65 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The goal of this clinical trial is to learn if oxytocin administered as a nasal spray will reduce withdrawal symptoms in adults during benzodiazepine tapering for 21 days. It will also learn about the safety of oxytocin. The main question it aims to answer are:\n\nDoes oxytocin reduce benzodiazepine withdrawal symptoms and make it easier to succeed tapering? Does oxytocin help reduce sleep difficulties and anxiety or restlessness during benzodiazepine tapering? Does oxytocin help reduce benzodiazepine craving?\n\nWe will compare oxytocin nasal spray to a placebo nasal spray containing regular saline to see if oxytocin works accordingly.\n\nParticipants will:\n\nTake oxytocin or a placebo nasalspray, thrice daily for 21 days during inpatient benzodiazepine tapering.\n\nFill out an online questionnaire every day and keep a record of their symptoms.",[92],"Benzodiazepine Dependence",[94,95,96,97,98],"intranasal oxytocin","oxytocin","benzodiazepines","benzodiazepine dependence","benzodiazepine withdrawal","2025-01-02",{"date":101,"type":102},"2025-01-03","ACTUAL",{"date":104,"type":102},"2022-03-01",{"date":106,"type":86},"2025-12-31",{"name":5,"class":6},1]