Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

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

doi:10.1016/j.pain.2012.07.035

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

Pain. 2012 Dec;153(12):2315-2324. doi: 10.1016/j.pain.2012.07.035. Epub 2012 Sep 19.

Affiliation

¹ Division on Substance Abuse, New York State Psychiatric Institute/College of Physicians and Surgeons, Columbia University, New York, NY, USA Department of Anesthesia and Critical Care, University of Chicago, Chicago, IL, USA Department of Anesthesiology, University of Rochester, Rochester, NY, USA Department of Anesthesiology, University of Washington, Seattle, WA, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA Department of Medicine, Johns Hopkins University, Baltimore, MD, USA Kendle Early Phase Toronto, Formerly Decision Line Clinical Research Corporation, Toronto, Ontario, Canada Covance, Princeton, NJ, USA Institute for Drug and Alcohol Studies, Virginia Commonwealth University, Richmond, VA, USA United States Food and Drug Administration, Silver Spring, MD, USA Colucci and Associates LLC, Newtown, CT, USA American Chronic Pain Association, Rocklin, CA, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Purdue Pharma L.P., Stamford, CT, USA Pfizer Inc., New London, CT, USA Psychiatry and Behavioral Sciences, Wayne State University, Detroit, MI, USA Eisai Limited, Woodcliff Lake, NJ, USA Analgesic Research, Needham, MA, USA Department of Anesthesiology, Tufts University, Boston, Massachusetts, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA CNS Drug Consulting LLC, McLean, VA, USA Department of Biostatistics, University of Rochester, Rochester, NY, USA Department of Neurology, University of Rochester, Rochester, NY, USA Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA Department of Medicine, University of Rochester, Rochester, NY, USA AcelRx Pharmaceuticals Inc., Redwood City, CA, USA Department of Anesthesiology and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA Johnson and Johnson Pharmaceutical Research and Development LLC, Raritan, NJ, USA Research Institute, California Pacific Medical Center, San Francisco, CA, USA Clinical Pharmacology and Therapeutics Laboratory, Faculdade de Medicina de Lisboa, Lisbon, Portugal King Pharmaceuticals Inc., Cary, NC, USA Grünenthal USA Inc., Bedminster, NJ, USA Durect Corporation, Cupertino, CA, USA Department of Behavioral Science, Center on Drug and Alcohol Research, University of Kentucky, KY, USA.

Abstract

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.

Published by Elsevier B.V.

MeSH terms

Analgesics, Opioid / adverse effects*
Clinical Trials as Topic / standards*
Humans
Internationality
Neurology / standards*
Opioid-Related Disorders / diagnosis*
Opioid-Related Disorders / etiology*
Outcome Assessment, Health Care / standards*
Practice Guidelines as Topic*
Risk Assessment

Substances

Analgesics, Opioid

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

Authors

Affiliation

Abstract

MeSH terms

Substances

Grants and funding