[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425212":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":34,"responsibleParty":56,"collaborators":30,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":30,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":37,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"High dose cannabis oil","EXPERIMENTAL","Single-dose 20.0 mg tetrahydrocannabinol + 20 mg cannabidiol, Sub-linguistic.",[13],"Drug: Single-dose of cannabis oil",{"label":15,"type":10,"description":16,"interventionNames":17},"Low dose cannabis oil","Single-dose 10 mg tetrahydrocannabinol + 10 mg cannabidiol, Sub-linguistic.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control","PLACEBO_COMPARATOR","Single-dose Olive oil that is similar in appearance and taste to cannabis oil",[23],"Drug: Control",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Single-dose of cannabis oil","Single-dose of cannabis oil in order to treat acute radicular pain",[9,15],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil",[19],[35],{"facility":36,"status":37,"city":38,"state":30,"zip":30,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hadassah Medical Center","RECRUITING","Jerusalem","Israel","IL",{"type":42,"coordinates":43},"Point",[44,45],35.21633,31.76904,{"lat":45,"lon":44},[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Elyad M Davidson, M.D","CONTACT","972-2-6776911","54211","edavidson@hadassah.org.il",{"name":49,"role":55,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100425212","phase-3-effect-of-cannabis-extract-on-acute-radicular-pain-and-on-analgesic-requirement-100425212",false,"NCT04816994","Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement","Effect of Cannabis Extract on Acute Radicular Pain and on Analgesic Requirement: A Double Blinded, Randomized, 24 Hours Follow-up Study","Inclusion Criteria:\n\n* Age 18 - 70 years\n* ASA 1 or 2\n* Acute Radicular Pain \\\u003C 12 weeks\n* Pain of VAS 6 or more\u002F VRS moderate or more\n* Radicular pain: Dermatomal pain that corresponds to physical exam and CT\u002FMRI in the last year\n\nExclusion Criteria:\n\n* Age \\\u003C 18 or \\> 70 years\n* ASA 3 or more\n* Chronic radicular pain \\> 12 weeks\n* Past spine surgery\n* Intermittent Claudication due to Vascular Disease\n* Diagnosed Diabetic Neuropathy\n* Regular Cannabis use in past 6 months (more than once a week) OR once in last 2 weeks\n* Regular opioid use in past week (Targin, Percocet, Tramadol) (Equivalent to Oxycodone 20 mg\u002Fday or more)\n* Pregnancy or Lactating\n* Ischemic heart disease\n* Renal or hepatic failure\n* History of psychiatric illness\n* Cognitive impairment or inability to answer questions\n* Known allergy to opioids\n* Potential Loss to follow up","ALL","18 Years","70 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention.\n\nCannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain and for renal colic.",[76,77],"Acute Radicular Back Pain","Cannabis",[79,77],"Acute radicular back pain","2025-09-29",{"date":82,"type":83},"2025-10-02","ACTUAL",{"date":85,"type":83},"2018-01-07",{"date":87,"type":70},"2025-12-31",{"name":5,"class":6},1]