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Opioid and cannabinoid combinations in laboratory and clinical pain

阿片类药物和大麻素组合在实验室和临床疼痛中的应用

基本信息

批准号：
9479123
负责人：
Claudia Michelle Campbell
金额：
$ 75.23万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-05-15 至 2020-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9479123
关键词：
Absence of pain sensation Adjuvant Adverse event Affect American Analgesics Animals Attenuated CNS processing Cannabinoids Chronic Clinical Clinical Data Clinical Treatment Clinical Trials Cognitive Confounding Factors (Epidemiology)Data Degenerative polyarthritis Dose Double-Blind Method Drug Combinations Drug Evaluation Drug Kinetics Elderly Evaluation Evaluation Studies FDA approved Foundations Human Individual Investigation Knee Osteoarthritis Laboratories Laboratory Study Literature Measurement Measures Mediating Methods Modeling N-Methylaspartate Nature Neurocognitive Nociception Opioid Opioid Analgesics Outcome Outcome Study Pain Pain management Participant Patients Performance Pharmaceutical Preparations Pharmacodynamics Physical Function Physiological Placebos Population Public Health Regimen Reporting Rodent Safety Sampling Sensory Signal Transduction Stimulus Testing central sensitization chronic pain chronic pain patient chronic painful condition clinical pain clinically relevant cognitive performance cohort disability drug testing human subject improved indexing opioid therapy pain behavior pain model pain reduction pre-clinical transmission process

项目摘要

This laboratory study will evaluate whether a cannabinoid enhances the analgesic efficacy of an opioid in a clinical sample of chronic pain patients, laying the foundation for a larger clinical trial evaluating the utility of cannabinoids as potentially opioid-sparing adjuvants to chronic opioid therapy for pain. Heightened CNS processing, or central sensitization (CS), occurs across numerous chronic pain conditions and is an important treatment target in its own right. While cannabinoids show initial promise as treatments or adjuncts for some chronic pain conditions and pre-clinical data suggest effects on CS, little is known about the degree to which combining cannabinoids with opioids alleviates CS-mediated chronic pain. We propose a within-subject, single exposure, double-blind, placebo-controlled, human laboratory investigation of the extent to which a cannabinoid enhances opioid analgesia in a model chronic pain population (e.g., patients with knee osteoarthritis). Human laboratory studies are an ideal method for this initial evaluation because they provide the opportunity to tightly control study drug dosing and afford high sensitivity of measurements, and enable tight control of confounding variables that may otherwise exist in clinical treatment populations and could differentially impact outcomes. This approach will minimize the number of participants needed to determine whether a positive signal exists while permitting rigorous and elegant evaluation of the study aims. Primary study outcomes will include measures of clinical pain and central sensitization, physical function, drug effects (e.g., abuse liability, adverse events, cognitive performance), and pharmacokinetic analyses. The Aims will examine the magnitude and duration of cannabinoid/opioid combination in reducing clinical pain and central sensitization; the effects on physical functioning, adverse events and indices of abuse liability; and the pharmacokinetic and pharmacodynamics profiles for the individual and combined drugs. This study will provide the most systematic and rigorous evaluation of the potential for cannabinoids to enhance analgesic effects of opioids in human subjects to date, and will do so in a relevant and generalizable clinical pain population who has CS, which makes these results more directly relevant compared to studies conducted in healthy populations. These findings will be critical to informing the efficacy and safety profile for the advancement of opioid/cannabinoid combination regimens to clinical trials with chronic pain patients.

本实验室研究将评估大麻素是否能增强阿片类药物的镇痛效果