Evaluation of US Food and Drug Administration-recommended abuse-potential questions in chronic pain patients without history of recreational opioid use: results and plan for research
Received 12 June 2018
Accepted for publication 2 November 2018
Published 17 December 2018 Volume 2019:12 Pages 9—15
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Katherine Hanlon
Joseph A Boscarino,1 Carrie A Withey,1 Ryan J Dugan,1 Thomas Alfieri2
1Department of Epidemiology and Health Services Research, Geisinger Clinic, Danville, PA 17822, USA; 2Medical Affairs, Purdue Pharma, Stamford, CT 06901, USA
Background: Existing patient-reported outcome (PRO) assessments that measure the human abuse potential for opioid analgesics have been tested exclusively in experienced recreational opioid users, as required by US Food and Drug Administration (FDA) guidance.
Methods: The goals of the current studies were to modify items from FDA-recommended abuse potential PRO assessments to specify the analgesic benefits versus the euphoric effects of opioids and to ascertain the clarity, understandability, appropriateness, and validity of the modified questions. This was achieved by conducting cognitive debriefing interviews (CDIs) with patients (≥18 and <65 years) who have chronic pain, were prescribed an opioid daily dose of at least 80 morphine-equivalent milligrams (>30 days to ≤180 days from the date of interview), and did not have a history of recreational opioid use.
Results: Participants in study 1 (n=30) and study 2 (n=7) had a better understanding of the items designed to measure the concepts of drug liking and items designed to measure the desire to take a drug again when reasons for liking and desire to take again were included in the item wording (namely, “due to pain relief” and “excluding pain relief”). Most participants indicated no interest in taking their medication for reasons other than pain relief.
Conclusion: Modification of questions in the PRO assessment improved patient understanding of “drug liking” and “desire to take again.” Patients with chronic pain who were not recreational opioid users understood the difference between the analgesic and euphoric effects of an opioid drug. The modified questions should assist future researchers in providing a more accurate assessment of the abuse potential of an opioid, as required by regulatory agencies.
Keywords: opioid analgesics, patient-reported outcomes, chronic pain, assessments, substance-related disorders, United States Food and Drug Administration, abuse potential
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