Cannabidiol for postoperative Opioid Reduction in primary total Knee arthroplasty – a randomized, 2x2 factorial, double-blind, placebo-controlled clinical trial (The CORK trial)
大麻二酚用于初次全膝关节置换术术后阿片类药物减少 — 一项随机、2x2 析因、双盲、安慰剂对照临床试验(CORK 试验)
基本信息
- 批准号:10733651
- 负责人:
- 金额:$ 127.54万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-18 至 2028-08-31
- 项目状态:未结题
- 来源:
- 关键词:AcuteAcute PainAdverse eventAffectAgeAmericanAnalgesicsAnimalsAnti-Anxiety AgentsAnti-Inflammatory AgentsAnxietyArthritisCannabidiolCannabinoidsCessation of lifeChildhoodChronicClient satisfactionClinicalClinical ResearchClinical TrialsConstipationControlled Clinical TrialsDevelopmentDizzinessDoseDouble-Blind MethodDrug KineticsEpidiolexEpilepsyFlareGeneral PopulationGood Manufacturing ProcessGrantHealth Care CostsHealth systemHumanInflammationInflammatoryInterleukin-6InvestigationInvestigational New Drug ApplicationKnee OsteoarthritisLiteratureMediatingMedicalMeta-AnalysisMethodologyModalityNauseaOperative Surgical ProceduresOpiate AddictionOpioidOpioid AnalgesicsOpioid RotationOutcomeOverdosePainPain managementParticipantPatientsPerioperativePersonsPharmaceutical PreparationsPlacebo ControlPlacebosPostoperative PainPostoperative PeriodPre-Clinical ModelPropertyRandomizedRandomized, Controlled TrialsReportingResearchResearch DesignRoleRotator CuffSafetySample SizeSeveritiesSiteSleepSleep disturbancesSourceSymptomsTestingTetrahydrocannabinolTherapeutic EffectTranslatingUnited StatesUnited States Food and Drug Administrationaddictionanxiety reductionchronic painclinical trial protocolcravingdesignfunctional improvementimprovedinflammatory markerknee replacement arthroplastymultimodalityopioid exposureopioid sparingopioid useopioid use disorderpain reductionpostoperative recoverypre-clinicalpreclinical studyprimary outcomerecruitrepairedsecondary outcomesexside effectsystematic review
项目摘要
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 effects,
with ~80% of surgical patients reporting at least one moderate or severe side effect (e.g. nausea, dizziness,
constipation). Moreover, perioperative opioid exposure is associated with patients becoming dependent on
opioids long after surgical recovery, and new chronic opioid dependence is subsequently associated with
increased healthcare costs, the development of opioid use disorder (addiction), overdose, and death. Hence,
research into opioid alternatives for postoperative pain is of critical importance. Cannabinoids,
including
cannabidiol (CBD), are one class of potential opioid-sparing pain medications. While CBD is used by an
estimated 14% of the general public, most frequently for chronic pain and related symptoms (including as an
opioid substitute), rigorous clinical research on CBD is limited. CBD shows great promise, as it is non-
intoxicating, and reduces pain, anxiety and inflammation in animal studies. Previous research has found that
CBD reduced opioid craving and anxiety, which further suggests it may decrease opioid use after surgery. It is
also well tolerated across numerous medical conditions. Moreover, CBD (Epidiolex), the study drug we will
use, is approved by the Food and Drug Administration for treating some seizure disorders, and it is not subject
to the same regulatory restrictions as
Δ
-9-tetrahydrocannabinol (THC). In this study, we will recruit 380 patients
undergoing primary total knee arthroplasty (TKA) from two large health systems. In this multi-site, 2x2 factorial,
double-blind, randomized controlled trial, participants will receive one of four combinations of placebo or CBD
(300 mg/day) for one week prior to surgery together with CBD or placebo for 4 weeks following surgery. Our
primary outcome will be post-operative opioid consumption in the 4-week period following surgery. The study
design will also allow us to investigate and untangle CBD's pre- and post-surgical effects, including reduction
of anxiety, sleep disturbance and inflammation. We will also conduct detailed investigations of the side effects
and adverse events, as well as pharmacokinetics of CBD throughout the treatment course. The successful
completion of this study will give much needed evidence for the role of CBD as an opioid-sparing medication
for pain after surgery. Given that there are more than 50 million surgeries each year in the United States, these
findings could have much broader implications beyond TKA and would motivate important new lines of
research into the role of CBD.
项目摘要/摘要
项目成果
期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kevin Foxman Boehnke其他文献
Kevin Foxman Boehnke的其他文献
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{{ truncateString('Kevin Foxman Boehnke', 18)}}的其他基金
Planning Grant for a Clinical Trial Of Cannabidiol For Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
大麻二酚用于初次全膝关节置换术术后阿片类药物减少的临床试验规划拨款
- 批准号:
10460651 - 财政年份:2021
- 资助金额:
$ 127.54万 - 项目类别:
Planning Grant for a Clinical Trial Of Cannabidiol For Postoperative Opioid Reduction in Primary Total Knee Arthroplasty
大麻二酚用于初次全膝关节置换术术后阿片类药物减少的临床试验规划拨款
- 批准号:
10294554 - 财政年份:2021
- 资助金额:
$ 127.54万 - 项目类别:
Cannabinoid Effects on Sleep and Pain Mechanisms in Osteoarthritis of the Knee
大麻素对膝骨关节炎睡眠和疼痛机制的影响
- 批准号:
10650850 - 财政年份:2020
- 资助金额:
$ 127.54万 - 项目类别:
Cannabinoid Effects on Sleep and Pain Mechanisms in Osteoarthritis of the Knee
大麻素对膝骨关节炎睡眠和疼痛机制的影响
- 批准号:
10212997 - 财政年份:2020
- 资助金额:
$ 127.54万 - 项目类别:
Cannabinoid Effects on Sleep and Pain Mechanisms in Osteoarthritis of the Knee
大麻素对膝骨关节炎睡眠和疼痛机制的影响
- 批准号:
10053803 - 财政年份:2020
- 资助金额:
$ 127.54万 - 项目类别:
Cannabinoid Effects on Sleep and Pain Mechanisms in Osteoarthritis of the Knee
大麻素对膝骨关节炎睡眠和疼痛机制的影响
- 批准号:
10436239 - 财政年份:2020
- 资助金额:
$ 127.54万 - 项目类别:
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