Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations
Year: 2012
Type: article
Abstract: Summary We recommend that four subjective effects measures should be included in ALA studies of opioid analgesics: drug liking, likelihood to take again, drug identification, and drug high. These can be considered core primary outcome measures, that is, core in the sense that these measures should be part of any opioid ALA battery, and primary in the sense that they are important measures in determining the AL of a drug. A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL have the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing the abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided, and those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are then discussed. These outcome measures include the following: subjective effects (some of which comprise the primary outcome measures, including drug liking; physiological responses; drug self-administration behavior; and cognitive and psychomotor performance. Before presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed.
Source: Pain
Authors: Sandra D. Comer, James P. Zacny, Robert H. Dworkin, Dennis C. Turk, George E. Bigelow, Richard W. Foltin, Donald R. Jasinski, Edward M. Sellers, Edgar H. Adams, Robert Balster, Laurie B. Burke, Igor Cerny, Robert D. Colucci, Edward Cone, Penney Cowan, John T. Farrar, David J. Haddox, Jennifer A. Haythornthwaite, Sharon Hertz, Gary W. Jay, Chris-Ellyn Johanson, Roderick Junor, Nathaniel P. Katz, Michael Klein, Ernest A. Kopecky, Deborah B. Leiderman, Michael P. McDermott, Charles O’Brien, Alec B. O’Connor, Pamela P. Palmer, Srinivasa N. Raja, Bob A. Rappaport, Christine Rauschkolb, Michael C. Rowbotham, Cristina Sampaio, Beatrice Setnik, Marta Sokolowska, Joseph W. Stauffer, Sharon L. Walsh
Institutions: Johns Hopkins University, Virginia Commonwealth University, University of Washington, Johns Hopkins Medicine, University of Rochester Medicine, University of Chicago, New York State Psychiatric Institute, University of Rochester, Columbia University, Covance (United States), United States Food and Drug Administration, Newport (United States), Canteen, American Chronic Pain Association, University of Pennsylvania, Purdue Pharma (United States), Pfizer (United States), Wayne State University, Eisai (United States), Tufts University, Endo Pharmaceuticals (United States), AcelRx Pharmaceuticals (United States), Janssen Research & Development (United States), California Pacific Medical Center, University of Lisbon, Durect (United States), University of Kentucky
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: National Institute on Drug Abuse
OpenAlex ID: W1990223458