title: Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations.
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.
authors.affiliation: 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.
authors.forename: Sandra D
authors.initials: SD
authors.lastname: Comer
authors.forename: James P
authors.initials: JP
authors.lastname: Zacny
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: George E
authors.initials: GE
authors.lastname: Bigelow
authors.forename: Richard W
authors.initials: RW
authors.lastname: Foltin
authors.forename: Donald R
authors.initials: DR
authors.lastname: Jasinski
authors.forename: Edward M
authors.initials: EM
authors.lastname: Sellers
authors.forename: Edgar H
authors.initials: EH
authors.lastname: Adams
authors.forename: Robert
authors.initials: R
authors.lastname: Balster
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: Igor
authors.initials: I
authors.lastname: Cerny
authors.forename: Robert D
authors.initials: RD
authors.lastname: Colucci
authors.forename: Edward
authors.initials: E
authors.lastname: Cone
authors.forename: Penney
authors.initials: P
authors.lastname: Cowan
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: David J
authors.initials: DJ
authors.lastname: Haddox
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Haythornthwaite
authors.forename: Sharon
authors.initials: S
authors.lastname: Hertz
authors.forename: Gary W
authors.initials: GW
authors.lastname: Jay
authors.forename: Chris-Ellyn
authors.initials: CE
authors.lastname: Johanson
authors.forename: Roderick
authors.initials: R
authors.lastname: Junor
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.forename: Michael
authors.initials: M
authors.lastname: Klein
authors.forename: Ernest A
authors.initials: EA
authors.lastname: Kopecky
authors.forename: Deborah B
authors.initials: DB
authors.lastname: Leiderman
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Charles
authors.initials: C
authors.lastname: O'Brien
authors.forename: Alec B
authors.initials: AB
authors.lastname: O'Connor
authors.forename: Pamela P
authors.initials: PP
authors.lastname: Palmer
authors.forename: Srinivasa N
authors.initials: SN
authors.lastname: Raja
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Christine
authors.initials: C
authors.lastname: Rauschkolb
authors.forename: Michael C
authors.initials: MC
authors.lastname: Rowbotham
authors.forename: Cristina
authors.initials: C
authors.lastname: Sampaio
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.forename: Marta
authors.initials: M
authors.lastname: Sokolowska
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Stauffer
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Walsh
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D038622:Internationality; D009462:Neurology / Q000592:standards*; D009293:Opioid-Related Disorders / Q000175:diagnosis* / Q000209:etiology*; D017063:Outcome Assessment, Health Care / Q000592:standards*; D017410:Practice Guidelines as Topic; D018570:Risk Assessment
chemical_list: D000701:Analgesics, Opioid