Buprenorphine/naloxone versus methadone opioid rotation in patients with prescription opioid use disorder and chronic pain: study protocol for a randomized controlled trial

Hannah Ellerbroek*, Sandra A. S. van den Heuvel, Albert Dahan, Hans Timmerman, Cornelis Kramers, Arnt F. A. Schellekens

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

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    Abstract

    Background: Opioids are effective in pain-management, but long-term opioid users can develop prescription opioid use disorder (OUD). One treatment strategy in patients with OUD is rotating from a short-acting opioid to a long-acting opioid (buprenorphine/naloxone (BuNa) or methadone). Both BuNa and methadone have been shown to be effective strategies in patients with OUD reducing opioid misuse, however data on head-to-head comparison in patients with chronic non-malignant pain and prescription OUD are limited.

    Methods: This two-armed open-label, randomized controlled trial aims to compare effectiveness between BuNa and methadone in patients with chronic non-malignant with prescription OUD (n=100). Participants receive inpatient rotation to either BuNa or methadone with a flexible dosing regimen.The primary outcome is opioid misuse 2 months after rotation. Secondary outcomes include treatment compliance, side effects, analgesia, opioid craving, quality of life, mood symptoms, cognitive and physical functioning over 2- and 6 months follow-up. Linear mixed model analysis will be used to evaluate change in outcome parameters over time between the treatment arms.

    Discussion: This is one of the first studies comparing buprenorphine/naloxone and methadone for treating prescription OUD in a broad patient group with chronic non-malignant pain. Results may guide future treatment for patients with chronic pain and prescription OUD.

    Original languageEnglish
    Article number47
    Number of pages11
    JournalAddiction Science and Clinical Practice
    Volume17
    Issue number1
    DOIs
    Publication statusPublished - 4-Sep-2022

    Keywords

    • Opioid use disorder
    • Methadone
    • Buprenorphine/naloxone
    • Chronic pain
    • Current opioid misuse measure
    • QUALITY-OF-LIFE
    • COGNITIVE FAILURES
    • NEUROPATHIC PAIN
    • SUBSTANCE USE
    • WHOQOL-BREF
    • VALIDITY
    • RELIABILITY
    • MAINTENANCE
    • VALIDATION
    • DEPRESSION

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