Abuse liability measures for use in analgesic clinical trials in patients with pain

IMMPACT recommendations

Alec B. O'Connor, Dennis C. Turk, Robert H. Dworkin, Nathaniel P. Katz, Robert Colucci, Jennifer Haythornthwaite, Michael Klein, Charles O'Brien, Kelly Posner, Bob A. Rappaport, Gary Reisfield, Edgar H. Adams, Robert L. Balster, George Bigelow, Laurie B. Burke, Sandra D. Comer, Edward Cone, Penney Cowan, Richard A. Denisco, John T. Farrar & 19 others Richard W. Foltin, J. David Haddox, Sharon Hertz, Gary W. Jay, Roderick Junor, Ernest A. Kopecky, Deborah B. Leiderman, Michael P. McDermott, Pamela P. Palmer, Srinivasa Naga Raja, Christine Rauschkolb, Michael C. Rowbotham, Cristina Sampaio, Beatrice Setnik, Shannon M. Smith, Marta Sokolowska, Joseph W. Stauffer, Sharon L. Walsh, James P. Zacny

Research output: Contribution to journalArticle

Abstract

Assessing and mitigating the abuse liability (AL) of analgesics is an urgent clinical and societal problem. Analgesics have traditionally been assessed in randomized clinical trials (RCTs) designed to demonstrate analgesic efficacy relative to placebo or an active comparator. In these trials, rigorous, prospectively designed assessment for AL is generally not performed. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) convened a consensus meeting to review the available evidence and discuss methods for improving the assessment of the AL of analgesics in clinical trials in patients with pain. Recommendations for improved assessment include: (1) performing trials that include individuals with diverse risks of abuse; (2) improving the assessment of AL in clinical trials (eg, training study personnel in the principles of abuse and addiction behaviors, designing the trial to assess AL outcomes as primary or secondary outcome measures depending on the trial objectives); (3) performing standardized assessment of outcomes, including targeted observations by study personnel and using structured adverse events query forms that ask all subjects specifically for certain symptoms (such as euphoria and craving); and (4) collecting detailed information about events of potential concern (eg, unexpected urine drug testing results, loss of study medication, and dropping out of the trial). The authors also propose a research agenda for improving the assessment of AL in future trials.

Original languageEnglish (US)
Pages (from-to)2324-2334
Number of pages11
JournalPain
Volume154
Issue number11
DOIs
StatePublished - 2013

Fingerprint

Pain Measurement
Analgesics
Clinical Trials
Pain
Outcome Assessment (Health Care)
Consensus
Randomized Controlled Trials
Placebos
Urine
Research
Pharmaceutical Preparations

Keywords

  • Abuse
  • Abuse liability
  • Clinical trial
  • Opioids
  • Prescription drug abuse
  • Risk of abuse
  • Study design

ASJC Scopus subject areas

  • Clinical Neurology
  • Anesthesiology and Pain Medicine
  • Neurology
  • Pharmacology
  • Medicine(all)

Cite this

O'Connor, A. B., Turk, D. C., Dworkin, R. H., Katz, N. P., Colucci, R., Haythornthwaite, J., ... Zacny, J. P. (2013). Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations. Pain, 154(11), 2324-2334. https://doi.org/10.1016/j.pain.2013.06.035

Abuse liability measures for use in analgesic clinical trials in patients with pain : IMMPACT recommendations. / O'Connor, Alec B.; Turk, Dennis C.; Dworkin, Robert H.; Katz, Nathaniel P.; Colucci, Robert; Haythornthwaite, Jennifer; Klein, Michael; O'Brien, Charles; Posner, Kelly; Rappaport, Bob A.; Reisfield, Gary; Adams, Edgar H.; Balster, Robert L.; Bigelow, George; Burke, Laurie B.; Comer, Sandra D.; Cone, Edward; Cowan, Penney; Denisco, Richard A.; Farrar, John T.; Foltin, Richard W.; Haddox, J. David; Hertz, Sharon; Jay, Gary W.; Junor, Roderick; Kopecky, Ernest A.; Leiderman, Deborah B.; McDermott, Michael P.; Palmer, Pamela P.; Raja, Srinivasa Naga; Rauschkolb, Christine; Rowbotham, Michael C.; Sampaio, Cristina; Setnik, Beatrice; Smith, Shannon M.; Sokolowska, Marta; Stauffer, Joseph W.; Walsh, Sharon L.; Zacny, James P.

In: Pain, Vol. 154, No. 11, 2013, p. 2324-2334.

Research output: Contribution to journalArticle

O'Connor, AB, Turk, DC, Dworkin, RH, Katz, NP, Colucci, R, Haythornthwaite, J, Klein, M, O'Brien, C, Posner, K, Rappaport, BA, Reisfield, G, Adams, EH, Balster, RL, Bigelow, G, Burke, LB, Comer, SD, Cone, E, Cowan, P, Denisco, RA, Farrar, JT, Foltin, RW, Haddox, JD, Hertz, S, Jay, GW, Junor, R, Kopecky, EA, Leiderman, DB, McDermott, MP, Palmer, PP, Raja, SN, Rauschkolb, C, Rowbotham, MC, Sampaio, C, Setnik, B, Smith, SM, Sokolowska, M, Stauffer, JW, Walsh, SL & Zacny, JP 2013, 'Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations', Pain, vol. 154, no. 11, pp. 2324-2334. https://doi.org/10.1016/j.pain.2013.06.035
O'Connor, Alec B. ; Turk, Dennis C. ; Dworkin, Robert H. ; Katz, Nathaniel P. ; Colucci, Robert ; Haythornthwaite, Jennifer ; Klein, Michael ; O'Brien, Charles ; Posner, Kelly ; Rappaport, Bob A. ; Reisfield, Gary ; Adams, Edgar H. ; Balster, Robert L. ; Bigelow, George ; Burke, Laurie B. ; Comer, Sandra D. ; Cone, Edward ; Cowan, Penney ; Denisco, Richard A. ; Farrar, John T. ; Foltin, Richard W. ; Haddox, J. David ; Hertz, Sharon ; Jay, Gary W. ; Junor, Roderick ; Kopecky, Ernest A. ; Leiderman, Deborah B. ; McDermott, Michael P. ; Palmer, Pamela P. ; Raja, Srinivasa Naga ; Rauschkolb, Christine ; Rowbotham, Michael C. ; Sampaio, Cristina ; Setnik, Beatrice ; Smith, Shannon M. ; Sokolowska, Marta ; Stauffer, Joseph W. ; Walsh, Sharon L. ; Zacny, James P. / Abuse liability measures for use in analgesic clinical trials in patients with pain : IMMPACT recommendations. In: Pain. 2013 ; Vol. 154, No. 11. pp. 2324-2334.
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abstract = "Assessing and mitigating the abuse liability (AL) of analgesics is an urgent clinical and societal problem. Analgesics have traditionally been assessed in randomized clinical trials (RCTs) designed to demonstrate analgesic efficacy relative to placebo or an active comparator. In these trials, rigorous, prospectively designed assessment for AL is generally not performed. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) convened a consensus meeting to review the available evidence and discuss methods for improving the assessment of the AL of analgesics in clinical trials in patients with pain. Recommendations for improved assessment include: (1) performing trials that include individuals with diverse risks of abuse; (2) improving the assessment of AL in clinical trials (eg, training study personnel in the principles of abuse and addiction behaviors, designing the trial to assess AL outcomes as primary or secondary outcome measures depending on the trial objectives); (3) performing standardized assessment of outcomes, including targeted observations by study personnel and using structured adverse events query forms that ask all subjects specifically for certain symptoms (such as euphoria and craving); and (4) collecting detailed information about events of potential concern (eg, unexpected urine drug testing results, loss of study medication, and dropping out of the trial). The authors also propose a research agenda for improving the assessment of AL in future trials.",
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AU - O'Connor, Alec B.

AU - Turk, Dennis C.

AU - Dworkin, Robert H.

AU - Katz, Nathaniel P.

AU - Colucci, Robert

AU - Haythornthwaite, Jennifer

AU - Klein, Michael

AU - O'Brien, Charles

AU - Posner, Kelly

AU - Rappaport, Bob A.

AU - Reisfield, Gary

AU - Adams, Edgar H.

AU - Balster, Robert L.

AU - Bigelow, George

AU - Burke, Laurie B.

AU - Comer, Sandra D.

AU - Cone, Edward

AU - Cowan, Penney

AU - Denisco, Richard A.

AU - Farrar, John T.

AU - Foltin, Richard W.

AU - Haddox, J. David

AU - Hertz, Sharon

AU - Jay, Gary W.

AU - Junor, Roderick

AU - Kopecky, Ernest A.

AU - Leiderman, Deborah B.

AU - McDermott, Michael P.

AU - Palmer, Pamela P.

AU - Raja, Srinivasa Naga

AU - Rauschkolb, Christine

AU - Rowbotham, Michael C.

AU - Sampaio, Cristina

AU - Setnik, Beatrice

AU - Smith, Shannon M.

AU - Sokolowska, Marta

AU - Stauffer, Joseph W.

AU - Walsh, Sharon L.

AU - Zacny, James P.

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