优化疼痛治疗，同时减少阿片类药物依赖的滥用责任-猫眼课题宝

优化疼痛治疗，同时减少阿片类药物依赖的滥用责任

批准号：

8492049

负责人：

David Andrew Tompkins

金额：

$18.57万

依托单位：

JOHNS HOPKINS UNIVERSITY

依托单位国家：

美国

项目类别：

财政年份：

2012

资助国家：

美国

项目状态：

已结题

起止时间：

2012-07-01 至 2017-05-31

来源：

https://reporter.nih.gov/project-details/8492049

关键词：

Absence of pain sensation Accident and Emergency department Acute Acute Pain Address Analgesics Area Attention Biological Factors Buprenorphine Chronic Clinical Clinical Pharmacology Clinical Trials Clinical Trials Design Clinical assessments Collection Complement Complex Conduct Clinical Trials Controlled Clinical Trials Data Disease Dose Double-Blind Method Drug Addiction Drug abuse Emotional Environmental Risk Factor Epidemic Evaluation Evaluation Methodology Exhibits Exposure to Funding Future Goals Grant Health Sciences Heating Histocompatibility Testing Hydromorphone Hyperalgesia Individual Individual Differences Intravenous Investigation Knowledge Lead Maintenance Measurement Measures Medical Mentored Patient-Oriented Research Career Development Award Mentors Methadone Modeling Musculoskeletal Pain Opiate Addiction Opioid Opioid Analgesics Outcome Pain Pain Measurement Pain Research Pain Threshold Pain management Pain-Free Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Pharmacological Treatment Phase Placebo Control Placebos Population Preparation Procedures Process Property Provider Psychological Factors Recruitment Activity Research Research Personnel Risk Sensory Severities System Techniques Testing Training Training Programs Treatment outcome Visit Work addiction behavioral pharmacology career career development chronic pain cost design effective therapy experience nonmedical use patient oriented prescription opioid prescription opioid abuse pressure research study response substance abuse treatment

中文摘要

翻译

描述(申请人提供)：处方类阿片类药物的滥用已成为一种全国性的流行病，导致吸毒成瘾的巨大社会成本。个人反复将疼痛作为这种障碍潜在和维持的主要原因，但关于疼痛如何影响药物滥用风险的了解有限。尽管行为药理学实验已经证实，使用主观和客观的药物效果测量作为滥用潜力的临床有价值的预测指标，但很少有系统的研究全面地检查阿片类药物依赖者在接触阿片类止痛剂后的止痛特性和滥用倾向测量。这项申请是为大卫·安德鲁·汤普金斯博士颁发的K23指导下的以患者为导向的研究职业发展奖，以发展其独立的研究生涯，进行临床试验，调查有效的疼痛管理策略，同时减少阿片类药物依赖者的滥用责任。在他的培训计划中，汤普金斯博士建议通过同时攻读临床调查健康科学硕士学位，参与正在进行的成瘾药物治疗的临床试验，并完成两项研究阿片类药物依赖者急性疼痛有效策略的新试验，来扩大他在临床试验设计、管理和分析方面的知识。新的试验将使汤普金斯博士获得定量感觉测试(QST)方面的专业知识，这是一种涉及多种实验性疼痛技术的综合评估方法，可以帮助研究人员和临床医生评估疼痛体验和有效的疼痛治疗。QST很少用于阿片类药物依赖人群，但最终可能为这些患者未来的疼痛研究提供一个有效和可靠的模型。汤普金斯博士将利用双盲安慰剂对照设计，在3组患者中衡量静脉注射氢化吗啡和丁丙诺啡的止痛剂(实验性痛阈值和耐受性的变化)、主观和客观药物效果：接受美沙酮治疗的无痛参与者(N=30)，接受丁丙诺啡治疗的无痛参与者(N=30)，以及有慢性肌肉骨骼疼痛的接受丁丙诺啡治疗的参与者(N=30)。在这三个不同的人群中收集QST和滥用责任数据将进一步调查维持剂和慢性肌肉骨骼疼痛在显著提高疼痛阈值和耐受性所需的药量方面的重要性。将考察QST止痛反应的个体差异，包括疼痛灾变量表(PCS)的使用，PCS是一种客观衡量疼痛的重要预期和情感方面的量表。这两项临床试验将补充培训计划，并有助于汤普金斯博士作为一名独立疼痛和成瘾研究人员的职业发展，其结果可用于准备R01，以(1)将工作扩展到更大的急性疼痛治疗的2/3期对照临床试验，和/或(2)探索其他止痛药或输送系统的临床试验。

英文摘要

DESCRIPTION (provided by applicant): The abuse of prescription opioids has become a national epidemic, contributing to the enormous societal costs of drug addiction. Individuals repeatedly give pain as a leading reason underlying and maintaining this disorder, but there exists limited knowledge into how pain influences the risk for drug abuse. Although behavioral pharmacology experiments have validated the use of subjective and objective measurements of drug effects as clinically valuable predictors of abuse potential, few systematic investigations have comprehensively examined both the analgesic properties and abuse liability measurements in persons with opioid dependence after exposure to opioid analgesics. This application is for a K23 Mentored Patient-Oriented Research Career Development Award for Dr. David Andrew Tompkins to develop an independent research career in conducting clinical trials investigating effective strategies for the management of pain while reducing abuse liability in persons with opioid dependence. In his training plan, Dr. Tompkins proposes to expand his knowledge of clinical trial design, management, and analysis by concurrently pursuing a Master in Health Science degree in Clinical Investigation, participating in ongoing clinical trials of pharmacological treatment of addiction, and completing two new trials examining effective strategies for the management of acute pain in persons with opioid dependence. The new trials will allow Dr. Tompkins to gain expertise in quantitative sensory testing (QST) - a comprehensive evaluation methodology involving multiple experimental pain techniques that can assist researchers and clinicians in assessing both pain experiences and effective pain treatments. QST has rarely been used in opioid dependent populations but may ultimately provide a valid and reliable model for future pain research with these patients. Dr. Tompkins will utilize a double-blind placebo controlled design to measure the analgesic (change in experimental pain threshold and tolerance), subjective, and objective drug effects provided by intravenous doses of hydromorphone and buprenorphine in 3 groups: pain-free methadone maintained participants (N=30), pain-free buprenorphine maintained participants (N=30), and buprenorphine maintained participants with chronic musculoskeletal pain (N=30). Collection of QST and abuse liability data in these three separate populations will additionally allow for an investigation of the importance of maintenance agent and chronic musculoskeletal pain in the amount of drug required for significant increases in pain threshold and tolerance. Individual differences in analgesic response to QST will be examined, including use of the pain catastrophizing scale (PCS) - a scale that objectively measures important anticipatory and emotional aspects of pain. These two clinical trials will complement the training plan and aid in Dr. Tompkins' career development as an independent pain and addiction researcher and the results can be used in preparation of an R01 to (1) extend the work to larger Phase 2/3 controlled clinical trials of acute pain treatment, and/or (2) clinical trials to explore additiona analgesic medications or delivery systems.

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