Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection

Hassman, Howard; Strafford, Stephanie; Shinde, Sunita; Heath, Amy; Boyett, Brent; Dobbins, Robert L.

doi:10.1080/00952990.2022.2106574

Cited by 5 publications

(9 citation statements)

References 22 publications

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Section: Discussionmentioning

confidence: 99%

“… 38 Adoption may also benefit from new resources, such as MDCalc, 39 and the BUP initiation application, 40 that integrate diagnostic questionnaires and treatment algorithms available on smart phones and embedded in EHR clinical decision tools. 41 , 42 A 2022 study 43 that investigated a clinical decision support tool for ED-initiated buprenorphine embedded in an EHR without other implementation strategies did not find an increase in patient rates of initiating buprenorphine but did find an increase in the number of physicians who initiated buprenorphine in the ED.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the use of long-acting formulations of buprenorphine and removal of barriers, such as insurance preauthorization, may impact the effectiveness of ED-initiated buprenorphine. 43 Removal of regulatory barriers, such as the recent removal of the requirement for an X-waiver, 44 may also improve adoption. Recently published studies retrospectively evaluating the implementation of ED-initiated buprenorphine have reported promising outcomes associated with use of active navigation 45 and peer recovery specialists, 46 highlighting that increases in adoption of ED-initiated buprenorphine would require additional strategies at the individual, institutional, and policy levels.…”

Section: Discussionmentioning

confidence: 99%

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Implementation Facilitation to Promote Emergency Department–Initiated Buprenorphine for Opioid Use Disorder

et al. 2023

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ImportanceEmergency department (ED)–initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused.ObjectiveTo evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy.Design, Setting, and ParticipantsThis multisite hybrid type 3 effectiveness-implementation nonrandomized trial compared grand rounds with IF, with pre-post 12-month baseline and IF evaluation periods, at 4 academic EDs. The study was conducted from April 1, 2017, to November 30, 2020. Participants were ED and community clinicians treating patients with OUD and observational cohorts of ED patients with untreated OUD. Data were analyzed from July 16, 2021, to July 14, 2022.ExposureA 60-minute in-person grand rounds was compared with IF, a multicomponent facilitation strategy that engaged local champions, developed protocols, and provided learning collaboratives and performance feedback.Main Outcomes and MeasuresThe primary outcomes were the rate of patients in the observational cohorts who received ED-initiated buprenorphine with referral for OUD treatment (primary implementation outcome) and the rate of patients engaged in OUD treatment at 30 days after enrollment (effectiveness outcome). Additional implementation outcomes included the numbers of ED clinicians with an X-waiver to prescribe buprenorphine and ED visits with buprenorphine administered or prescribed and naloxone dispensed or prescribed.ResultsA total of 394 patients were enrolled during the baseline evaluation period and 362 patients were enrolled during the IF evaluation period across all sites, for a total of 756 patients (540 [71.4%] male; mean [SD] age, 39.3 [11.7] years), with 223 Black patients (29.5%) and 394 White patients (52.1%). The cohort included 420 patients (55.6%) who were unemployed, and 431 patients (57.0%) reported unstable housing. Two patients (0.5%) received ED-initiated buprenorphine during the baseline period, compared with 53 patients (14.6%) during the IF evaluation period (P &lt; .001). Forty patients (10.2%) were engaged with OUD treatment during the baseline period, compared with 59 patients (16.3%) during the IF evaluation period (P = .01). Patients in the IF evaluation period who received ED-initiated buprenorphine were more likely to be in treatment at 30 days (19 of 53 patients [35.8%]) than those who did not 40 of 309 patients (12.9%; P &lt; .001). Additionally, there were increases in the numbers of ED clinicians with an X-waiver (from 11 to 196 clinicians) and ED visits with provision of buprenorphine (from 259 to 1256 visits) and naloxone (from 535 to 1091 visits).Conclusions and RelevanceIn this multicenter effectiveness-implementation nonrandomized trial, rates of ED-initiated buprenorphine and engagement in OUD treatment were higher in the IF period, especially among patients who received ED-initiated buprenorphine.Trial RegistrationClinicalTrials.gov Identifier: NCT03023930

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Implementation Facilitation to Promote Emergency Department–Initiated Buprenorphine for Opioid Use Disorder

et al. 2023

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“…Inpatient induction procedures were completed during the first 48 h and outpatient treatment continued for up to 6 monthly injections. A schematic of induction procedures is shown in Figure 1 and full induction procedures are described in the primary clinical trial report 28 . The primary trial was an open‐label, single‐group, single‐center pilot study that evaluated safety and tolerability of initiating BUP‐XR following a single BUP‐TM 4 mg dose.…”

Section: Methodsmentioning

confidence: 99%

“…If POW from BUP‐TM occurred, the BUP‐TM induction could be restarted later the same or the next day. Rescue medications (clonidine, ondansetron, trazodone, ibuprofen, and loperamide) and supplemental BUP‐TM were permitted after BUP‐XR to treat withdrawal symptoms; psychosocial counseling was implemented as described in the primary clinical trial report 28 . The protocol permitted the use of supplemental BUP‐TM after BUP‐XR injection on Day 1.…”

Section: Methodsmentioning

confidence: 99%

Open‐label investigation of rapid initiation of extended‐release buprenorphine in patients using fentanyl and fentanyl analogs

Mariani,

Dobbins,

Heath

et al. 2023

American J Addict

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Background and ObjectivesSynthetic opioids, including fentanyl and fentanyl analogs, account for over 70,000 annual overdose deaths in the United States, but there is limited information examining methods of induction and maintenance outcomes for buprenorphine treatment of patients with opioid use disorder (OUD) using these opioids.MethodsA secondary analysis of results grouped by fentanyl use status was completed for an open‐label study with rapid induction of extended‐release buprenorphine in the inpatient research unit. Eligible participants received a single 4 mg dose of transmucosal buprenorphine (BUP‐TM) followed by an extended‐release buprenorphine 300 mg injection ([BUP‐XR]) after approximately 1 h. An extension study continued follow‐up up to 6 months (6 monthly injections).ResultsAmong participants with fentanyl‐positive urine samples (FEN+; n = 19), all received BUP‐TM, 17 received BUP‐XR, 13 elected to receive a second BUP‐XR injection, and 10 received all six scheduled injections. Among participants with fentanyl‐negative samples (FEN−; n = 7), all received BUP‐TM and BUP‐XR, four elected to receive a second injection, and two participants received all six scheduled injections. Induction day clinical opioid withdrawal scale (COWS) scores were similar for FEN+ and FEN− groups. In the FEN+ group, mean COWS scores fell to below 5 within 24 h of BUP‐XR injection.Discussion and ConclusionsThe treatment of individuals with OUD using fentanyl with a rapid 1‐day induction to BUP‐XR 300 mg injection is feasible and well‐tolerated.Scientific SignificanceA prospective trial of participants grouped by fentanyl use status at induction demonstrates comparable patient retention and clinical response following single‐day induction of BUP‐XR in participants who are FEN+ and FEN−.

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Emergency department management of opioid use disorder in pediatric patients

Schwarz,

Dietrich,

Sandelich

et al. 2024

JACEP Open

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Opioid use disorder (OUD) has emerged as a significant public health crisis affecting individuals across all age groups. However, there remains a critical gap in understanding the specific nuances and challenges associated with OUD in pediatric populations. This article provides a comprehensive review of the epidemiology, definition of OUD, screening recommendations for OUD, and evidence‐based management strategies for OUD in pediatric patients.

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Open-label, rapid initiation pilot study for extended-release buprenorphine subcutaneous injection

Cited by 5 publications

References 22 publications

Implementation Facilitation to Promote Emergency Department–Initiated Buprenorphine for Opioid Use Disorder

Implementation Facilitation to Promote Emergency Department–Initiated Buprenorphine for Opioid Use Disorder

Open‐label investigation of rapid initiation of extended‐release buprenorphine in patients using fentanyl and fentanyl analogs

Emergency department management of opioid use disorder in pediatric patients

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