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

摘要

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 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.