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

• Published in: Pain (Amsterdam) Vol. 153; no. 12; pp. 2315 - 2324
• Main Authors: Comer, Sandra D., Zacny, James P., Dworkin, Robert H., Turk, Dennis C., Bigelow, George E., Foltin, Richard W., Jasinski, Donald R., Sellers, Edward M., Adams, Edgar H., Balster, Robert, Burke, Laurie B., Cerny, Igor, Colucci, Robert D., Cone, Edward, Cowan, Penney, Farrar, John T., David Haddox, J., Haythornthwaite, Jennifer A., Hertz, Sharon, Jay, Gary W., Johanson, Chris-Ellyn, Junor, Roderick, Katz, Nathaniel P., Klein, Michael, Kopecky, Ernest A., Leiderman, Deborah B., McDermott, Michael P., O’Brien, Charles, O’Connor, Alec B., Palmer, Pamela P., Raja, Srinivasa N., Rappaport, Bob A., Rauschkolb, Christine, Rowbotham, Michael C., Sampaio, Cristina, Setnik, Beatrice, Sokolowska, Marta, Stauffer, Joseph W., Walsh, Sharon L.
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Elsevier B.V 01-12-2012; Lippincott Williams & Wilkins, Inc; Elsevier
• Subjects: Abuse; Abuse liability; Abuse potential; Analgesics; Analgesics, Opioid - adverse effects; Biological and medical sciences; Clinical Trials as Topic - standards; Fundamental and applied biological sciences. Psychology; Humans; Illness and personality; Illness, stress and coping; Internationality; Medical sciences; Neurology - standards; Neuropharmacology; Opioid analgesics; Opioid-Related Disorders - diagnosis; Opioid-Related Disorders - etiology; Opioids; Outcome Assessment, Health Care - standards; Pharmacology. Drug treatments; Practice Guidelines as Topic; Psychology and medicine; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Risk Assessment; Abuse liability; Abuse; Abuse potential; Opioids; Opioid analgesics; Human; Standardization; Self administration; Recommendation; Analgesic; Pain; Dependence; Risk factor; Behavior; Respiratory depression; Performance; Public health
• ISSN: 0304-3959; 1872-6623
• DOI: 10.1016/j.pain.2012.07.035

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.