[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552485":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":64,"collaborators":66,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":32,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":48,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Vejle Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dronabinol 20 mg, then placebo","EXPERIMENTAL","In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks.",[13,14],"Drug: Dronabinol 2.5mg Capsule","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo, then dronabinol 20 mg","PLACEBO_COMPARATOR","In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks.",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dronabinol 2.5mg Capsule","Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.",[9,16],[27],"Delta9-tetrahydrocannabinol",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Dronabinol-matched placebo capsule containing no active substance.",[9,16],null,[34],{"name":35,"affiliation":36,"role":37},"Ole Hilberg, Prof., MD","Medical Department, Vejle Hospital","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Sofie K Wolsing, MSc, RN","CONTACT","+45 79409055","swolsing@health.sdu.dk",{"name":5,"role":41,"phone":32,"phoneExt":32,"email":32},[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Vejle Hospital - A part of Lillebaelt Hospital","RECRUITING","Vejle","Region Syddanmark","7100","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],9.5357,55.70927,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":32,"email":43},"Sofie K Wolsing","0045",{"type":65,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[67,69,71,73],{"name":68,"class":6},"Region of Southern Denmark",{"name":70,"class":6},"Odense Patient Data Explorative Network",{"name":72,"class":6},"University of Southern Denmark",{"name":74,"class":6},"University of Aarhus","100552485","phase-3-reducing-breathlessness-with-dronabinol-in-copd-patients-100552485",false,"NCT06473701","Reducing Breathlessness With Dronabinol in COPD Patients","BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study","BONG","Inclusion Criteria:\n\n* Refractory dyspnea despite optimal treatment\n* COPD (GOLD 3,4)\n* Breathlessness corresponding to mMRC score ≥ 3\n* Informed written consent\n* Age ≥ 18 years\n* Cognitive relevant, of legal age\n* Understands and speaks Danish\n* For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial\n* For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).\n\nExclusion Criteria:\n\n* Ongoing infection or exacerbation of COPD within the last month (30 days)\n* Regular treatment with THC or CBD within 1 month (30 days)\n* Life expectancy less than 3 months (90 days)\n* Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19\n* History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event\n* Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study","ALL","18 Years",{"count":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).",[93,94,95],"COPD","Breathlessness","Cannabis",[97,98,95,93,94],"Randomized, Controlled, Double-blind, Crossover trial","Cannabis-based medicine","2026-04-16",{"date":101,"type":102},"2026-04-17","ACTUAL",{"date":104,"type":102},"2025-02-26",{"date":106,"type":87},"2026-10",{"name":5,"class":6},1]