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; Kerry Wolf

doi:10.1016/j.pain.2012.05.029

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 JacobsRichard 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, Kerry Wolf

Research output: Contribution to journal › Review article › peer-review

24 Scopus citations

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 language	English (US)
Pages (from-to)	1997-2008
Number of pages	12
Journal	Pain
Volume	153
Issue number	10
DOIs	https://doi.org/10.1016/j.pain.2012.05.029
State	Published - Oct 2012
Externally published	Yes

Keywords

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

ASJC Scopus subject areas

Neurology
Clinical Neurology
Anesthesiology and Pain Medicine

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10.1016/j.pain.2012.05.029

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Turk, D. C., O'Connor, A. B., Dworkin, R. H., Chaudhry, A., Katz, N. P., Adams, E. H., Brownstein, J. S., Comer, S. D., Dart, R., Dasgupta, N., Denisco, R. A., Klein, M., Leiderman, D. B., Lubran, R., Rappaport, B. A., Zacny, J. P., Ahdieh, H., Burke, L. B., Cowan, P., ... 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

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

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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.",

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AU - Chaudhry, Amina

AU - Katz, Nathaniel P.

AU - Adams, Edgar H.

AU - Brownstein, John S.

AU - Comer, Sandra D.

AU - Dart, Richard

AU - Dasgupta, Nabarun

AU - Denisco, Richard A.

AU - Klein, Michael

AU - Leiderman, Deborah B.

AU - Lubran, Robert

AU - Rappaport, Bob A.

AU - Zacny, James P.

AU - Ahdieh, Harry

AU - Burke, Laurie B.

AU - Cowan, Penney

AU - Jacobs, Petra

AU - Malamut, Richard

AU - Markman, John

AU - Michna, Edward

AU - Palmer, Pamela

AU - Peirce-Sandner, Sarah

AU - Potter, Jennifer S.

AU - Raja, Srinivasa N.

AU - Rauschkolb, Christine

AU - Roland, Carl L.

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AU - Weiss, Roger D.

AU - Wolf, Kerry

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N2 - 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.

AB - 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.

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KW - Abuse liability

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KW - Risk of abuse

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JF - Pain

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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