[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443295":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":91,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":51,"eligibilityCriteria":102,"healthyVolunteers":99,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":51,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":51,"overallStatus":73,"whyStopped":51,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,16,20,24,28,32,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Analgesia Arm: THC (tetrahydrocannabinol), then THC\u002FCBD (cannabidiol), then Placebo","EXPERIMENTAL","Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on THC\u002FCBD oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],"Drug: THC\u002FCBD","Drug: THC","Drug: Placebo",{"label":17,"type":10,"description":18,"interventionNames":19},"Analgesia Arm: THC, then Placebo, then THC\u002FCBD","Subjects in this crossover arm will be assigned to 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC\u002FCBD oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Analgesia Arm: THC\u002FCBD, then THC, then Placebo","Subjects in this crossover arm will be assigned to 6 weeks on THC\u002FCBD oral solution, then 6 weeks on THC oral solution, then 6 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Analgesia Arm: THC\u002FCBD, then Placebo, then THC","Subjects in this crossover arm will be assigned to 6 weeks on THC\u002FCBD oral solution, then 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Analgesia Arm: Placebo, then THC, then THC\u002FCBD","Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC oral solution, then 6 weeks on THC\u002FCBD oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Analgesia Arm: Placebo, then THC\u002FCBD, then THC","Subjects in this crossover arm will be assigned to 6 weeks on Placebo oral solution, then 6 weeks on THC\u002FCBD oral solution, then 6 weeks on THC oral solution. Frequency of drug administration is 3-4 times a day.",[13,14,15],{"label":37,"type":10,"description":38,"interventionNames":39},"Reduction Arm: THC\u002FCBD","Subjects in this parallel arm will be assigned to 13 weeks on THC\u002FCBD oral solution. Frequency of drug administration is 3-4 times a day.",[13],{"label":41,"type":42,"description":43,"interventionNames":44},"Reduction Arm: Placebo","PLACEBO_COMPARATOR","Subjects in this parallel arm will be assigned to 13 weeks on Placebo oral solution. Frequency of drug administration is 3-4 times a day.",[15],[46,52,56],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","THC\u002FCBD","Oral solution containing 5mg THC and 50 mg CBD per 1 ml",[29,33,9,17,25,21,37],null,{"type":47,"name":53,"description":54,"armGroupLabels":55,"otherNames":51},"THC","Oral solution containing 5mg THC per 1 ml",[29,33,9,17,25,21],{"type":47,"name":57,"description":58,"armGroupLabels":59,"otherNames":51},"Placebo","Oral solution containing no active drug",[29,33,9,17,25,21,41],[61],{"name":62,"affiliation":5,"role":63},"Emily Lindley, PhD","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":51,"email":69},"Mustafa Al-Mafrachi, MPH","CONTACT","303-724-0923","spinepainstudy@cuanschutz.edu",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-104.83192,39.72943,{"lat":83,"lon":82},[86,89],{"name":62,"role":67,"phone":87,"phoneExt":51,"email":88},"303-724-0239","emily.lindley@cuanschutz.edu",{"name":90,"role":63,"phone":51,"phoneExt":51,"email":51},"Rachael Rzasa Lynn, MD",{"type":92,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[94],{"name":95,"class":96},"Institute of Cannabis Research","UNKNOWN","100443295","phase-3-safety-and-efficacy-of-oral-cannabis-in-chronic-spine-pain-100443295",false,"NCT05052541","Safety and Efficacy of Oral Cannabis in Chronic Spine Pain","Some inclusion\u002Fexclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.\n\nInclusion Criteria:\n\nSelf-reported chronic (≥3 months' duration), non-radicular spine pain\n\nExclusion Criteria:\n\nUnwilling\u002Funable to refrain from cannabis use (medical or recreational) for 14 days prior to Baseline Visit and throughout the study (other than study drug). This includes whole plant inhalation, edibles, extracts, and topicals.\n\nCo-morbid cancer-related pain condition\n\nNeuropathic Pain\n\nA co-morbid pain condition that is of greater severity than the patient's spine pain\n\nSpine or other major surgery within the 3 months prior to enrollment\n\nPlanned surgery or procedural intervention during the study period\n\nAllergy or adverse reaction to cannabis\n\nCurrent or historical substance use disorder\n\nCurrent or historical alcohol use disorder\n\nCurrent or prior cannabis abuse\u002Fdependence\n\nPositive result for use of amphetamine\u002Fmethamphetamine, barbiturates, benzodiazepines, cocaine, phencyclidine (PCP), ecstasy (MDMA), as detected on urine screen\n\nCurrent use of valproate, clobazam, clopidogrel, warfarin, barbiturates, benzodiazepines\n\nPrior adverse reaction to cannabis exposure (paranoia, anxiety, etc.)\n\nHistory or diagnosis of schizophrenia, bipolar or a psychotic disorder\n\nHistory of any mental health illness that in the opinion of the Investigator would compromise the safety of the participant\n\nCurrent or historical severe depression\n\nCurrent suicidal ideation\n\nDiagnosed cognitive impairment (e.g. Alzheimer's Disease, traumatic brain injury)\n\nUncontrolled hypertension (\\>139\u002F89)\n\nAbnormal values on CBC (complete blood count) or CMP (comprehensive metabolic panel) laboratory analysis that are deemed clinically significant by study physician\n\nKnown hepatic disease or dysfunction, or identification of such on screening laboratory studies\n\nKnown cardiovascular disease\n\nAbnormal result on electrocardiogram (ECG) that is deemed clinically significant by study MD\n\nCognitive disability that interferes with ability to provide consent or understand study procedure\n\nHistory of seizure disorder\n\nAny medical condition for which immunosuppressive therapy is required.\n\nInability to refrain from using tobacco for at least 4 hours\n\nPresence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data\n\nPending legal action or workers compensation\n\nPregnant females or females intending to become pregnant during the study period\n\nUnwilling to use one of the accepted forms of contraception during the study period and for at least 60 days after completion of the study (females of childbearing potential and males with sexual partners of childbearing potential)\n\nLactating females\n\nAnalgesia Arm Exclusion Criteria:\n\nUnwilling\u002Funable to discontinue current opioid use for 14 days prior to Baseline study visit and throughout the study\n\nReduction Arm Exclusion Criteria:\n\nNot interested in reducing or discontinuing use of prescribed opioids for chronic pain\n\nUnwilling to allow the study team to communicate with the participant's opioid prescribing provider\n\n\\*Some inclusion\u002Fexclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.","ALL","21 Years","84 Years",{"count":107,"type":108},157,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.",[114,115],"Back Pain","Neck Pain","2026-01-21",{"date":118,"type":119},"2026-01-23","ACTUAL",{"date":121,"type":108},"2026-01",{"date":123,"type":108},"2027-06",{"name":5,"class":6},1]