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

Authors :
Ellerbroek H
van den Heuvel SAS
Dahan A
Timmerman H
Kramers C
Schellekens AFA
Source :
Addiction science & clinical practice [Addict Sci Clin Pract] 2022 Sep 04; Vol. 17 (1), pp. 47. Date of Electronic Publication: 2022 Sep 04.
Publication Year :
2022

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.<br />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 (nā€‰=ā€‰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.<br />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. Trial registration https://www.trialregister.nl/ , NL9781.<br /> (© 2022. The Author(s).)

Details

Language :
English
ISSN :
1940-0640
Volume :
17
Issue :
1
Database :
MEDLINE
Journal :
Addiction science & clinical practice
Publication Type :
Academic Journal
Accession number :
36057608
Full Text :
https://doi.org/10.1186/s13722-022-00326-1