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, J. David Haddox, Jennifer A. Haythornthwaite, Sharon Hertz, Gary W. JayChris 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

Research output: Contribution to journalReview article

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.

Original languageEnglish (US)
Pages (from-to)2315-2324
Number of pages10
JournalPain
Volume153
Issue number12
DOIs
StatePublished - Dec 2012

Keywords

  • Abuse
  • Abuse liability
  • Abuse potential
  • Opioid analgesics
  • Opioids

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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    Comer, S. D., Zacny, J. P., Dworkin, R. H., Turk, D. C., Bigelow, G. E., Foltin, R. W., Jasinski, D. R., Sellers, E. M., Adams, E. H., Balster, R., Burke, L. B., Cerny, I., Colucci, R. D., Cone, E., Cowan, P., Farrar, J. T., David Haddox, J., Haythornthwaite, J. A., Hertz, S., ... Walsh, S. L. (2012). Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations. Pain, 153(12), 2315-2324. https://doi.org/10.1016/j.pain.2012.07.035