Matching study design to prescribing intention: The prevalent new-user design for studying abuse-deterrent formulations of opioids

Bethany L. DiPrete, GYeon Oh, Daniela C. Moga, Nabarun Dasgupta, Svetla Slavova, Emily Slade, Chris Delcher, Brian W. Pence, Shabbar I. Ranapurwala

Research output: Contribution to journalArticlepeer-review


Purpose: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by “indication” are important considerations in ADF post-marketing studies. Methods: In a retrospective cohort study using claims data (2006–2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18–64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six-month washout period) or prevalent new users. Results: We identified 8415 (NC claims) and 147 978 (MarketScan) ADF, and 10 114 (NC claims) and 232 028 (MarketScan) non-ADF ER/LA opioid initiators. Most had prior opioid exposure (ranging 64%–74%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non-ADF ER/LA initiators. Concurrent immediate-release opioid prescriptions at initiation were more common in prevalent new users than traditional new users. Conclusions: Careful consideration of the study design, comparator choice, and confounding by “indication” is crucial when examining ADF opioid use-related outcomes.

Original languageEnglish
Article numbere5805
JournalPharmacoepidemiology and Drug Safety
Issue number5
StatePublished - May 2024

Bibliographical note

Publisher Copyright:
© 2024 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.


  • opioid analgesics
  • opioid prescribing
  • opioid related disorder
  • postmarketing evaluation studies
  • study design

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)


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