滥用防御型阿片类镇痛药临床研究的设计考虑因素：IMMPACT 建议。
Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.
机构信息
University of Washington, Seattle, Washington, USA University of Rochester, Rochester, New York, USA Johns Hopkins University, Baltimore, Maryland, USA Analgesic Solutions and Tufts University, Boston, Massachusetts, USA Covance, Conshohocken, Pennsylvania, USA Harvard Medical School, Boston, Massachusetts, USA Columbia University, New York, USA Denver Health Authority and Rocky Mountain Poison and Drug Center, Denver, Colorado, USA University of North Carolina, Chapel Hill, North Carolina, USA National Institute on Drug Abuse, Bethesda, Maryland, USA United States Food and Drug Administration, Silver Spring, Maryland, USA CNS Drug Consulting, McLean, Virginia, USA University of Chicago, Chicago, Illinois, USA Endo Pharmaceuticals, Chadds Ford, Pennsylvania, USA American Chronic Pain Association, Rocklin, California, USA AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA Brigham and Women's Hospital, Boston, Massachusetts, USA AcelRx Pharmaceuticals, Redwood City, California, USA University of Texas Health Science Center San Antonio, San Antonio, Texas, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey, USA Pfizer, New Brunswick, New Jersey, USA Clinical Research and Pain Clinic, Salt Lake City, Utah, USA NAMA Recovery, Cedar Park, Texas, USA.
出版信息
Pain. 2012 Oct;153(10):1997-2008. doi: 10.1016/j.pain.2012.05.029. Epub 2012 Jul 5.
Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Because of the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability, (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation, (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse, and (4) postmarketing epidemiological studies.
阿片类药物对于许多患者的疼痛管理至关重要，但它们也存在滥用、过量和转移的潜在风险。已经投入了许多努力来开发阿片类药物的防滥用配方，以降低这些风险。本文总结了一次共识会议，该会议旨在提出用于评估不同阿片类药物配方的防滥用性能的临床研究类型的建议。由于可能接触到阿片类药物的个体类型众多，因此需要使用各种研究设计在多个人群中研究阿片类药物配方，以确定其防滥用能力。建议用于评估防滥用的研究应包括评估以下方面的研究：(1) 滥用倾向，(2) 阿片类药物滥用者是否会找到规避配方的防滥用特性的方法，(3) 在涉及低滥用风险和高滥用风险的疼痛患者的随机临床试验中进行误用和滥用的措施，以及 (4) 上市后流行病学研究。
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