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

Sandra D Comer¹, James P Zacny, Robert H Dworkin+36

• ¹Division 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.