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 & 12 others Richard Malamut, John Markman, Edward Michna, Pamela Palmer, Sarah Peirce-Sandner, Jennifer S. Potter, Srinivasa Naga Raja, Christine Rauschkolb, Carl L. Roland, Lynn R. Webster, Roger D. Weiss, Kerry Wolf

Research output: Contribution to journalArticle

Abstract

Opioids 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.

Original languageEnglish (US)
Pages (from-to)1997-2008
Number of pages12
JournalPain
Volume153
Issue number10
DOIs
StatePublished - Oct 2012

Fingerprint

Opioid Analgesics
Research Design
Pain Management
Clinical Studies
Epidemiologic Studies
Consensus
Randomized Controlled Trials
Pain
Research
Population

Keywords

  • Abuse
  • Abuse deterrent formulation
  • Abuse liability
  • Opioids
  • Risk of abuse
  • Study design

ASJC Scopus subject areas

  • Clinical Neurology
  • Anesthesiology and Pain Medicine
  • Neurology
  • Pharmacology

Cite this

Turk, D. C., O'Connor, A. B., Dworkin, R. H., Chaudhry, A., Katz, N. P., Adams, E. H., ... Wolf, K. (2012). Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations. Pain, 153(10), 1997-2008. https://doi.org/10.1016/j.pain.2012.05.029

Research design considerations for clinical studies of abuse-deterrent opioid analgesics : IMMPACT recommendations. / Turk, Dennis C.; O'Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa Naga; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry.

In: Pain, Vol. 153, No. 10, 10.2012, p. 1997-2008.

Research output: Contribution to journalArticle

Turk, DC, O'Connor, AB, Dworkin, RH, Chaudhry, A, Katz, NP, Adams, EH, Brownstein, JS, Comer, SD, Dart, R, Dasgupta, N, Denisco, RA, Klein, M, Leiderman, DB, Lubran, R, Rappaport, BA, Zacny, JP, Ahdieh, H, Burke, LB, Cowan, P, Jacobs, P, Malamut, R, Markman, J, Michna, E, Palmer, P, Peirce-Sandner, S, Potter, JS, Raja, SN, Rauschkolb, C, Roland, CL, Webster, LR, Weiss, RD & Wolf, K 2012, 'Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations', Pain, vol. 153, no. 10, pp. 1997-2008. https://doi.org/10.1016/j.pain.2012.05.029
Turk, Dennis C. ; O'Connor, Alec B. ; Dworkin, Robert H. ; Chaudhry, Amina ; Katz, Nathaniel P. ; Adams, Edgar H. ; Brownstein, John S. ; Comer, Sandra D. ; Dart, Richard ; Dasgupta, Nabarun ; Denisco, Richard A. ; Klein, Michael ; Leiderman, Deborah B. ; Lubran, Robert ; Rappaport, Bob A. ; Zacny, James P. ; Ahdieh, Harry ; Burke, Laurie B. ; Cowan, Penney ; Jacobs, Petra ; Malamut, Richard ; Markman, John ; Michna, Edward ; Palmer, Pamela ; Peirce-Sandner, Sarah ; Potter, Jennifer S. ; Raja, Srinivasa Naga ; Rauschkolb, Christine ; Roland, Carl L. ; Webster, Lynn R. ; Weiss, Roger D. ; Wolf, Kerry. / Research design considerations for clinical studies of abuse-deterrent opioid analgesics : IMMPACT recommendations. In: Pain. 2012 ; Vol. 153, No. 10. pp. 1997-2008.
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