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- Title
Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial.
- Authors
Nunes, Edward V.; Comer, Sandra D.; Lofwall, Michelle R.; Walsh, Sharon L.; Peterson, Stefan; Tiberg, Fredrik; Hjelmstrom, Peter; Budilovsky-Kelley, Natalie R.
- Abstract
Key Points: Question: What is the effectiveness of sublingual buprenorphine-naloxone or injections of extended-release subcutaneous buprenorphine for opioid use disorder (OUD) with fentanyl use? Findings: In this post hoc analysis of a randomized 24-week clinical trial with 428 participants, the percentage of urine samples negative for opioids among participants with fentanyl use was 28.5% for subcutaneous buprenorphine and 18.8% for buprenorphine-naloxone and 36.7% for subcutaneous buprenorphine and 30.6% for buprenorphine-naloxone among those without fentanyl use; among participants with fentanyl use, the percentage of urine samples negative for fentanyl was 74.6% for subcutaneous buprenorphine vs 61.9% for buprenorphine-naloxone. Opioid withdrawal and craving diminished rapidly across groups. Meaning: This study suggests that buprenorphine appears effective for treating OUD with fentanyl use; the extended-release injected formulation may provide an advantage in reducing fentanyl use. Importance: Fentanyl has exacerbated the opioid use disorder (OUD) and opioid overdose epidemic. Data on the effectiveness of medications for OUD among patients using fentanyl are limited. Objective: To assess the effectiveness of sublingual or extended-release injection formulations of buprenorphine for the treatment of OUD among patients with and without fentanyl use. Design, Setting, and Participants: Post hoc analysis of a 24-week, randomized, double-blind clinical trial conducted at 35 outpatient sites in the US from December 2015 to November 2016 of sublingual buprenorphine-naloxone vs extended-release subcutaneous injection buprenorphine (CAM2038) for patients with OUD subgrouped by presence vs absence of fentanyl or norfentanyl in urine at baseline. Study visits with urine testing occurred weekly for 12 weeks, then 6 times between weeks 13 and 24. Data were analyzed on an intention-to-treat basis from March 2022 to August 2023. Intervention: Weekly and monthly subcutaneous buprenorphine vs daily sublingual buprenorphine-naloxone. Main Outcomes and Measures: Retention in treatment, percentage of urine samples negative for any opioids (missing values imputed as positive), percentage of urine samples negative for fentanyl or norfentanyl (missing values not imputed), and scores on opiate withdrawal scales and visual analog craving scales. Results: Of 428 participants, 123 (subcutaneous buprenorphine, n = 64; sublingual buprenorphine-naloxone, n = 59; mean [SD] age, 39.1 [10.8] years; 75 men [61.0%]) had evidence of baseline fentanyl use and 305 (subcutaneous buprenorphine, n = 149; buprenorphine-naloxone, n = 156; mean [SD] age, 38.1 [11.1] years; 188 men [61.6%]) did not have evidence of baseline fentanyl use. Study completion was similar between the fentanyl-positive (60.2% [74 of 123]) and fentanyl-negative (56.7% [173 of 305]) subgroups. The mean percentage of urine samples negative for any opioid were 28.5% among those receiving subcutaneous buprenorphine and 18.8% among those receiving buprenorphine-naloxone in the fentanyl-positive subgroup (difference, 9.6%; 95% CI, −3.0% to 22.3%) and 36.7% among those receiving subcutaneous buprenorphine and 30.6% among those receiving buprenorphine-naloxone in the fentanyl-negative subgroup (difference, 6.1%; 95% CI, −1.9% to 14.1%), with significant main associations of baseline fentanyl status and treatment group. In the fentanyl-positive subgroup, the mean percentage of urine samples negative for fentanyl during the study was 74.6% among those receiving subcutaneous buprenorphine vs 61.9% among those receiving sublingual buprenorphine-naloxone (difference, 12.7%; 95% CI, 9.6%-15.9%). Opioid withdrawal and craving scores decreased rapidly after treatment initiation across all groups. Conclusions and Relevance: In this post hoc analysis of a randomized clinical trial of sublingual vs extended-release injection buprenorphine for OUD, buprenorphine appeared to be effective among patients with baseline fentanyl use. Patients with fentanyl use had fewer opioid-negative urine samples during the trial compared with the fentanyl-negative subgroup. These findings suggest that the subcutaneous buprenorphine formulation may be more effective at reducing fentanyl use. Trial Registration: ClinicalTrials.gov Identifier: NCT02651584 This post hoc analysis of a randomized clinical trial assesses the effectiveness of sublingual or extended-release injection formulations of buprenorphine for the treatment of opioid use disorder (OUD) among patients with and without fentanyl use.
- Subjects
UNITED States; SUBSTANCE abuse; CONTROLLED release preparations; SUBLINGUAL drug administration; DATA analysis; RESEARCH funding; HUMAN beings; INTERVIEWING; TREATMENT effectiveness; DESCRIPTIVE statistics; GAS chromatography; STATISTICS; NARCOTICS; MASS spectrometry; NALOXONE; COMPARATIVE studies; DATA analysis software; CONFIDENCE intervals; BUPRENORPHINE; FENTANYL; SUBCUTANEOUS injections
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2417377
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.17377