grant
Cannabidiol for postoperative Opioid Reduction in primary total Knee arthroplasty – a randomized, 2x2 factorial, double-blind, placebo-controlled clinical trial (The CORK trial)
Organization UNIVERSITY OF MICHIGAN AT ANN ARBORLocation ANN ARBOR, UNITED STATESPosted 18 Sept 2023Deadline 31 Aug 2028
NIHUS FederalResearch GrantFY20259-ene-TetrahydrocannabinolAcuteAcute PainAcutely painfulAdverse ExperienceAdverse eventAffectAgeAmericanAnalgesic AgentsAnalgesic DrugsAnalgesic PreparationAnalgesicsAnimalsAnodynesAnti-Anxiety AgentsAnti-Anxiety DrugsAnti-InflammatoriesAnti-Inflammatory AgentsAnti-inflammatoryAntinociceptive AgentsAntinociceptive DrugsAnxietyAnxiolytic AgentsAnxiolyticsArthritisB cell differentiation factorB cell stimulating factor 2B-Cell Differentiation FactorB-Cell Differentiation Factor-2B-Cell Stimulatory Factor-2BCDFBSF-2BSF2CannabidiolCannabinoidsCessation of lifeChildhoodChronicClient satisfactionClinicalClinical ResearchClinical StudyClinical TrialsConstipationControlled Clinical TrialsD9-tetrahydrocannabinolDeathDelta-9-TetrahydrocannabinolDevelopmentDizzinessDoseDouble-Blind MethodDouble-Blind StudyDouble-BlindedDouble-Masked MethodDouble-Masked StudyDrug KineticsDrugsEpidiolexEpilepsyEpileptic SeizuresEpilepticsFlareFood and Drug AdministrationGeneral PopulationGeneral PublicGood Manufacturing ProcessGood manufacturing practiceGrantHPGFHealth Care CostsHealth CostsHealth systemHepatocyte-Stimulating FactorHumanHybridoma Growth FactorIFN-beta 2IFNB2IL-6IL6 ProteinIND FilingIND applicationIND packageIND submissionInflammationInflammatoryInterleukin-6InvestigationInvestigational New Drug ApplicationKnee OsteoarthritisKnee arthroplastyKnee joint replacement operationKnee replacementLiteratureMGI-2MediatingMedicalMedicationMeta-AnalysisMethodologyMinor Tranquilizing AgentsModalityModern ManMyeloid Differentiation-Inducing ProteinNarcotic RotationNarcotic SubstitutionNarcotic SwitchingNauseaOperative ProceduresOperative Surgical ProceduresOpiate AddictionOpiate DependenceOpiatesOpioidOpioid AnalgesicsOpioid RotationOpioid SubstitutionOpioid SwitchingOutcomeOverdosePainPain ControlPain TherapyPain managementPainfulParticipantPatient SatisfactionPatientsPerioperativePersonsPharmaceutical PreparationsPharmacokineticsPlacebo ControlPlacebosPlasmacytoma Growth FactorPost-operative PainPostoperativePostoperative PainPostoperative PeriodPre-Clinical ModelPreclinical ModelsPropertyRandomizedRandomized, Controlled TrialsReportingResearchResearch DesignRoleRotator CuffSafetySample SizeSeizure DisorderSeveritiesSham TreatmentSiteSleepSleep disturbancesSourceStudy TypeSurgicalSurgical InterventionsSurgical ProcedureSymptomsTestingTetrahydrocannabinolTherapeutic EffectTotal Knee ReplacementTranslatingUSFDAUnited StatesUnited States Food and Drug Administrationaberrant sleepaddictionaddictive disorderagesanxiety reductionarthriticchronic painclinical trial protocolcravingdelta(1)-THCdelta(1)-Tetrahydrocannabinoldelta(9)-THCdelta(9)-Tetrahydrocannabinoldesigndesigningdevelopmentaldisrupted sleepdisturbed sleepdrug/agentepilepsiaepileptogenicfunctional improvementimpaired sleepimprove functionimprovedimproved functional outcomesinflammation markerinflammatory markerinterferon beta 2irregular sleepknee OAknee joint OAknee joint osteoarthritisknee replacement arthroplastymulti-modalitymultimodalityopiate analgesiaopiate analgesicopiate consumptionopiate drug useopiate exposureopiate intakeopiate pain medicationopiate pain relieveropiate useopiate use disorderopioid addictionopioid analgesiaopioid anestheticopioid consumptionopioid dependenceopioid dependentopioid drug useopioid exposureopioid intakeopioid pain medicationopioid pain relieveropioid painkilleropioid sparingopioid useopioid use disorderpain after surgerypain interventionpain killerpain medicationpain reductionpain relieverpain treatmentpainkillerpediatricplacebo controlledpost-surgical painpostoperative recoverypostsurgical painpre-clinicalpre-clinical studypreclinicalpreclinical studyprimary outcomerandomisationrandomizationrandomized control trialrandomly assignedrecovery after surgeryrecovery following surgeryrecruitreduce painrepairrepairedsecondary outcomesexsham therapyside effectsleep disruptionsleep dysregulationsleep/wake disruptionsleep/wake disturbancesocial rolestudy designsurgerysystematic reviewtotal knee arthroplastyΔ(1)-THCΔ(1)-tetrahydrocannabinolΔ(9)-THCΔ(9)-tetrahydrocannabinolΔ-9-tetrahydrocannabinolΔ9-tetrahydrocannabinol
Description preview
PROJECT SUMMARY / ABSTRACT
Knee osteoarthritis is a very common and debilitating condition, affecting >14 million Americans. Many people
with knee osteoarthritis require total knee arthroplasty (TKA) to treat pain and improve function, and opioids
remain the primary modality for treatment of pain after TKA. However, opioids carry significant side…
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