[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549536":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":123,"collaborators":25,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":25,"enrollmentInfo":134,"targetDuration":25,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":147,"whyStopped":25,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"University Hospital, Brest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cannabis oil","EXPERIMENTAL","CBD:THC oil 50mg\u002FmL arm :\n\nAn auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say then only 0.1 per day , up to 1 ml\u002Fday maximum.\n\nIf any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.\n\nAfter initial titration, the dose will then be maintained for 4 consecutive weeks.",[13],"Drug: Cannabis oil",{"label":15,"type":16,"description":17,"interventionNames":18},"PLACEBO","PLACEBO_COMPARATOR","Placebo arm :\n\nAn auto-titration phase will take place during the first 14 days of treatment with the same modalities as experimental group If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.\n\nAfter initial titration, the dose will then be maintained for 4 consecutive weeks.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients in this arm will have to take Cannabis oil (50mg\u002FmL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)",[15],[31],{"name":32,"role":33,"phone":25,"phoneExt":25,"email":34},"Laurent MISERY, PU-PH","CONTACT","laurent.misery@chu-brest.fr",[36,53,67,81,95,109],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":39,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"CHU Angers","Angers","France","49000","FR",{"type":43,"coordinates":44},"Point",[45,46],-0.55202,47.47156,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":25,"email":52},"YANNICK LE CORRE, MD","02 41 35 34 19","yalecorre@chu-angers.fr",{"facility":54,"status":25,"city":55,"state":39,"zip":56,"country":39,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"CHD Vendée","La Roche-sur-Yon","85925",{"type":43,"coordinates":58},[59,60],-1.42757,46.66974,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":65,"phoneExt":25,"email":66},"Carole POIRAUD, MD","02 51 44 61 83","Carole.poiraud@ght85.fr",{"facility":68,"status":25,"city":69,"state":39,"zip":70,"country":39,"countryCode":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Groupe Hospitalier La Rochelle","La Rochelle","17300",{"type":43,"coordinates":72},[73,74],-1.15222,46.16308,{"lat":74,"lon":73},[77],{"name":78,"role":33,"phone":79,"phoneExt":25,"email":80},"Cécile FRENARD, MD","05 45 45 51 83","Cecile.frenard@ght-atlantique17.fr",{"facility":82,"status":25,"city":83,"state":39,"zip":84,"country":39,"countryCode":41,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"CHU de Nantes","Nantes","44093",{"type":43,"coordinates":86},[87,88],-1.55336,47.21725,{"lat":88,"lon":87},[91],{"name":92,"role":33,"phone":93,"phoneExt":25,"email":94},"Sebastien BARBAROT, MD-PHD","02 40 08 40 86","sebastien.barbarot@chu-nantes.fr",{"facility":96,"status":25,"city":97,"state":39,"zip":98,"country":39,"countryCode":41,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"CHU de Poitiers","Poitiers","86000",{"type":43,"coordinates":100},[101,102],0.34348,46.58261,{"lat":102,"lon":101},[105],{"name":106,"role":33,"phone":107,"phoneExt":25,"email":108},"Ewa HAINAUT, MD","05 49 44 44 59","Ewa.HAINAUT@chu-poitiers.fr",{"facility":110,"status":25,"city":111,"state":39,"zip":112,"country":39,"countryCode":41,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"CHRU de Tours","Tours","37044",{"type":43,"coordinates":114},[115,116],0.70398,47.39484,{"lat":116,"lon":115},[119],{"name":120,"role":33,"phone":121,"phoneExt":25,"email":122},"Laurent MACHET, MD-PHD","02 47 47 87 73","machet@univ-tours.fr",{"type":124,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100549536","phase-2-efficacy-and-tolerance-of-thc-25-cbd-25-in-patients-with-severe-pruritus-a-multicenter-double-blind-randomized-placebo-controlled-study-100549536",false,"NCT06435299","Efficacy and Tolerance of THC 25: CBD 25 in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study","CANNA-ITCH","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Severe pruritus, defined by a mean WI-NRS score ≥7\u002F10 (evaluated on one week before inclusion, regardless of the cause of the pruritus\n* Insufficient relief (WI-NRS ≥7\u002F10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies\n* Stable treatment (for treatment of the prurit) for at least 6 weeks\n* Affiliated or benefiting of a social security\n* Informed consent (personally dated and) signed by the participant or any representatives (impartial witness\u002Ftrusted person)\n\nExclusion Criteria:\n\n* Patients unable to consent.\n* Patients refusing to participate in research.\n* Patients under guardianship or conservatorship.\n* Personal history of psychotic disorders.\n* Severe hepatic impairment, defined as prothrombin level \\\u003C50% or with predictive biological impairment.\n* Moderate to severe renal impairment, with an estimated glomerular filtration rate ≤ 44 mL\u002Fmin\u002F1.73 m².\n* Severe cardiovascular or cerebrovascular disease, including history of myocardial infarction or stroke.\n* Pregnant or breastfeeding women.\n* Lack of understanding of questionnaires or inability to follow up.\n* Women of childbearing potential unwilling to use appropriate contraception.\n* Cannabinoid use outside the clinical trial\n* Use of cannabis or its derivatives less than one week before inclusion\n* History of hypersensitivity or allergy to any cannabinoid product.\n* Allergy to nuts.","ALL","18 Years",{"count":135,"type":136},218,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","Chronic pruritus affects 10-20% of the population and causes a major reduction in quality of life, comparable to pain, with significant psychological, social, and functional consequences. Current treatments are often insufficient, highlighting the urgent need for new therapeutic options.\n\nRecent advances in the pathophysiology of itch have shown the involvement of the endocannabinoid system (CB1, CB2, and TRPV1 receptors) in modulating itch signal transmission and cutaneous inflammation. Cannabinoids, particularly the balanced CBD:THC combination, appear promising as they provide both central and peripheral antipruritic effects, while CBD helps mitigate the psychotropic side effects of THC.\n\nPreclinical studies and limited clinical data suggest efficacy across various forms of pruritus (dermatological, uremic, cholestatic), though robust controlled trials are still lacking. Evidence from nabiximols (1:1 CBD:THC spray) in other conditions such as neuropathic pain and spasticity further supports the rationale for this approach.\n\nTherefore, sublingual LGP THC25:CBD25 oil has been selected for its balanced ratio, simple administration route, and expected tolerability, to evaluate its efficacy and safety in the treatment of chronic pruritus.",[142],"Pruritus",[144,145,146],"itching","THC","CBD","NOT_YET_RECRUITING","2026-06-10",{"date":150,"type":151},"2026-06-12","ACTUAL",{"date":153,"type":136},"2027-01-01",{"date":155,"type":136},"2029-03-01",{"name":5,"class":6},6]