[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466289":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":44,"centralContacts":52,"locations":61,"responsibleParty":147,"collaborators":35,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":35,"enrollmentInfo":158,"targetDuration":35,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":35,"overallStatus":64,"whyStopped":35,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"THC (Syndros)","ACTIVE_COMPARATOR","Target dose of 10mg per day.",[13,14],"Drug: THC (Syndros)","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"CBD (Epidolex)","Target dose of 800 mg per day.",[19,14],"Drug: CBD (Epidolex)",{"label":21,"type":10,"description":22,"interventionNames":23},"THC + CBD (Nabiximols)","Target dose of 10.8 mg \u002F 10 mg per day.",[24,14],"Drug: THC + CBD (Nabiximols)",{"label":26,"type":27,"description":28,"interventionNames":29},"Placebo","PLACEBO_COMPARATOR","Identical in appearance to the three active comparators.",[14],[31,36,39,42],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Participants will receive a target dose of 10mg per day of THC (Syndros).",[9],null,{"type":32,"name":16,"description":37,"armGroupLabels":38,"otherNames":35},"Participants will receive a target dose of 800 mg per day of CBD (Epidolex).",[16],{"type":32,"name":21,"description":40,"armGroupLabels":41,"otherNames":35},"Participants will receive a target dose of 10.8 mg \u002F 10 mg per day of THC + CBD (Nabiximols).",[21],{"type":32,"name":26,"description":26,"armGroupLabels":43,"otherNames":35},[16,26,9,21],[45,49],{"name":46,"affiliation":47,"role":48},"Deepak D'Souza, MD MBBS","VA Connecticut Healthcare System West Haven Campus, West Haven, CT","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Donald McGeary, PhD","South Texas Health Care System, San Antonio, TX",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},"Courtney C DiCocco","CONTACT","(203) 932-5711","Courtney.DiCocco@va.gov",{"name":59,"role":55,"phone":56,"phoneExt":35,"email":60},"Mohini Ranganathan, MD","Mohini.Ranganathan@va.gov",[62,81,91,105,121,136],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"VA San Diego Healthcare System, San Diego, CA","RECRUITING","San Diego","California","92161-0002","United 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Haven","Connecticut","06516-2770",{"type":71,"coordinates":96},[97,98],-72.94705,41.27065,{"lat":98,"lon":97},[101,104],{"name":46,"role":55,"phone":56,"phoneExt":102,"email":103},"2594","Deepak.DSouza@va.gov",{"name":46,"role":48,"phone":35,"phoneExt":35,"email":35},{"facility":106,"status":64,"city":107,"state":108,"zip":109,"country":68,"countryCode":69,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Providence VA Medical Center, Providence, RI","Providence","Rhode Island","02908-4734",{"type":71,"coordinates":111},[112,113],-71.41283,41.82399,{"lat":113,"lon":112},[116],{"name":117,"role":55,"phone":118,"phoneExt":119,"email":120},"Jane Metrik, PhD","401-273-7100","3400","jane.metrik@va.gov",{"facility":51,"status":64,"city":122,"state":123,"zip":124,"country":68,"countryCode":69,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"San Antonio","Texas","78229-4404",{"type":71,"coordinates":126},[127,128],-98.49363,29.42412,{"lat":128,"lon":127},[131],{"name":132,"role":55,"phone":133,"phoneExt":134,"email":135},"Muhammad Baig, MD","210-617-5300","18244","muhammad.baig@va.gov",{"facility":137,"status":138,"city":139,"state":140,"zip":141,"country":68,"countryCode":69,"cosmosGeoPoint":142,"geoPoint":146,"contacts":35},"VA Puget Sound Health Care System Seattle Division, Seattle, WA","TERMINATED","Seattle","Washington","98108-1532",{"type":71,"coordinates":143},[144,145],-122.33207,47.60621,{"lat":145,"lon":144},{"type":148,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100466289","phase-2-proof-of-concept-trial-of-cannabis-derivatives-in-neuropathic-pain-100466289",false,"NCT05351801","Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain","CAN","Inclusion Criteria:\n\n* Able to provide written consent\n* Veterans 21 years and older at the date of screening\n* Meet diagnostic criteria for neuropathic pain as defined by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG)\n* Meet criteria for persistent, high-impact pain criteria.\n* Presence of allodynia confirmed by one of the screening dynamic brush tests\n* women of childbearing potential who agree to abide by contraceptive requirements\n\nExclusion Criteria:\n\n* Actively engaged in or planning to enter a program of non-pharmacological invasive intervention for pain at the time of enrollment\n* Peripheral neuropathy is not a primary source of neuropathic pain\n* Hypersensitivity to THC, CBD, or THC\u002FCBD\n* Self-report of cannabis use during screening phase confirmed by positive urine toxicology for THC-COOH as measured and resulted at visit 5 before randomization\n* Unwilling to refrain from using cannabis or cannabis-based products through the entire duration of the study\n* Diagnosis of DSM-5 Cannabis Use Disorder in the past 6 months\n* Current DSM-5 diagnosis of cannabis use disorder, substance use disorder or serious psychiatric disorders\n* Actual change or intent to change is greater than a 20% change (increase or decrease) in any other medication for pain or non-pharmacological treatment from 4 weeks before the screening appointment until completion of study (i.e., visit 13)\n* Opioid doses \\> 400 mg MME (morphine milligram equivalent)\n* Women who are pregnant or breastfeeding, or who intend to become pregnant in the 12 weeks from enrollment\n* Any current unstable or concerning medical condition that would place the patient at increased risk, including hepatic, respiratory, immunological, cardiovascular, endocrine, or renal disease, or in the opinion of the investigator, prevents adherence with the protocol\n* Need for immediate psychiatric hospitalization\n* Enrolled in a medical marijuana program\n* Federal employee","ALL","21 Years",{"count":159,"type":160},320,"ESTIMATED","INTERVENTIONAL",[163],"PHASE2","Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.",[166,167],"Neuropathic Pain","Peripheral Neuropathic Pain","2026-02-23",{"date":170,"type":171},"2026-02-27","ACTUAL",{"date":173,"type":171},"2023-06-21",{"date":175,"type":160},"2029-05-31",{"name":5,"class":6},6]