• Pain · Oct 2012


    Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.

    • Dennis C Turk, Alec B O'Connor, Robert H Dworkin, Amina Chaudhry, Nathaniel P Katz, Edgar H Adams, John S Brownstein, Sandra D Comer, Richard Dart, Nabarun Dasgupta, Richard A Denisco, Michael Klein, Deborah B Leiderman, Robert Lubran, Bob A Rappaport, James P Zacny, Harry Ahdieh, Laurie B Burke, Penney Cowan, Petra Jacobs, Richard Malamut, John Markman, Edward Michna, Pamela Palmer, Sarah Peirce-Sandner, Jennifer S Potter, Srinivasa N Raja, Christine Rauschkolb, Carl L Roland, Lynn R Webster, Roger D Weiss, and Kerry Wolf.
    • University of Washington, Seattle, Washington, USA. turkdc@uw.edu
    • Pain. 2012 Oct 1;153(10):1997-2008.

    AbstractOpioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Because of the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability, (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation, (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse, and (4) postmarketing epidemiological studies.Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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