Low-Dose Buprenorphine Initiation for Hospitalized Patients With Chronic Pain and Opioid Use Disorder or Opioid Misuse: Protocol for an Open-Label, Parallel-Group, Effectiveness-Implementation Randomized Controlled Trial.

Autor: Hayes BT; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Sanchez Fat G; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Torres-Lockhart K; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Khalid L; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Minami H; Psychology Department, Fordham University, Bronx, NY, USA., Ghiroli M; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Hribar MB; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Pacifico J; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Bao Y; Population Health Sciences, Weill Cornell Medicine, New York, NY, USA., Rodgers CRR; Department of Psychology and Behavioral Sciences, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Gabbay V; Department of Psychology and Behavioral Sciences, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Starrels J; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA., Fox AD; Division of General Internal Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.
Jazyk: angličtina
Zdroj: Substance use & addiction journal [Subst Use Addctn J] 2024 Jul 28, pp. 29767342241263221. Date of Electronic Publication: 2024 Jul 28.
DOI: 10.1177/29767342241263221
Abstrakt: Buprenorphine is an effective medication for both opioid use disorder (OUD) and chronic pain (CP), but transitioning from full opioid agonists to buprenorphine, a partial opioid agonist, can be challenging. Preliminary studies suggest that low-dose buprenorphine initiation can overcome some challenges in starting treatment, but no randomized controlled trials have compared low-dose and standard buprenorphine initiation approaches regarding effectiveness and safety or examined implementation in hospital settings. In a pragmatic open-label hybrid type I effectiveness-implementation trial based in a single urban health system, 270 hospitalized patients with (a) CP and (b) OUD or opioid misuse are being randomized to buprenorphine treatment initiation using 5-day low-dose or standard initiation protocols. Outcomes include buprenorphine treatment uptake (primary), defined as receiving buprenorphine treatment 7 days after enrollment, and other OUD and pain outcomes at 1-, 3-, and 6-month follow-up (secondary). Data collection will also include safety measures, implementation of low-dose initiation protocols, patient acceptability, and cost-effectiveness. Comparing strategies in a randomized clinical trial will provide the most definitive data to date regarding the effectiveness and safety of low-dose buprenorphine initiation. The study will also provide important data on treating CP at a time that clinical guidelines are evolving to center buprenorphine as a preferred opioid for CP.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Databáze: MEDLINE