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Implementation of Oral and Extended-Release Naltrexone for the Treatment of Emergency Department Patients With Moderate to Severe Alcohol Use Disorder: Feasibility and Initial Outcomes

Anderson, Erik S; Chamberlin, Mac; Zuluaga, Marisa; Ullal, Monish; Hawk, Kathryn; McCormack, Ryan; D'Onofrio, Gail; Herring, Andrew A
STUDY OBJECTIVE/OBJECTIVE:Despite evidence supporting naltrexone as an effective treatment for alcohol use disorder, its use in emergency department (ED) patients has not been described. We implemented a protocol that combined substance use navigation with either oral naltrexone or extended-release intramuscular naltrexone for patients with alcohol use disorder as a strategy to improve follow-up in addiction treatment after ED discharge. METHODS:In this descriptive study, we analyzed the results from adult patients discharged from the ED with moderate to severe alcohol use disorder who received either oral naltrexone or extended-release intramuscular naltrexone between May 1, 2020, and October 31, 2020, and assessed their engagement in formal addiction treatment within 30 days after discharge from the ED. RESULTS:Among 59 patients with moderate to severe alcohol use disorder who accepted naltrexone treatment, 41 received oral naltrexone and 18 received extended-release intramuscular naltrexone. The mean (SD) age of the patients was 45.2 (13.4) years; 22 patients (37.3%) were Latinx, 18 (30.5%) were Black, and 16 (27.1%) were White. Among all patients, 9 (15.3%) attended follow-up formal addiction treatment within 30 days after discharge; 5 patients (27.8%) who received extended-release intramuscular naltrexone and 4 patients (9.8%) who received oral naltrexone attended follow-up treatment within 30 days. CONCLUSION/CONCLUSIONS:We implemented a clinical protocol for ED patients with moderate to severe alcohol use disorder using oral naltrexone and extended-release intramuscular naltrexone together with substance use navigation. Identification of alcohol use disorder, a brief intervention, and initiation of naltrexone resulted in a 15% follow-up rate in formal addiction treatment. Future work should prospectively examine the effectiveness of naltrexone as well as the effect of substance use navigation for ED patients with alcohol use disorder.
PMID: 34353648
ISSN: 1097-6760
CID: 5006002

High-Dose Buprenorphine Induction in the Emergency Department for Treatment of Opioid Use Disorder

Herring, Andrew A; Vosooghi, Aidan A; Luftig, Joshua; Anderson, Erik S; Zhao, Xiwen; Dziura, James; Hawk, Kathryn F; McCormack, Ryan P; Saxon, Andrew; D'Onofrio, Gail
Importance/UNASSIGNED:Emergency departments (EDs) sporadically use a high-dose buprenorphine induction strategy for the treatment of opioid use disorder (OUD) in response to the increasing potency of the illicit opioid drug supply and commonly encountered delays in access to follow-up care. Objective/UNASSIGNED:To examine the safety and tolerability of high-dose (>12 mg) buprenorphine induction for patients with OUD presenting to an ED. Design, Setting, and Participants/UNASSIGNED:In this case series of ED encounters, data were manually abstracted from electronic health records for all ED patients with OUD treated with buprenorphine at a single, urban, safety-net hospital in Oakland, California, for the calendar year 2018. Data analysis was performed from April 2020 to March 2021. Interventions/UNASSIGNED:ED physicians and advanced practice practitioners were trained on a high-dose sublingual buprenorphine induction protocol, which was then clinically implemented. Main Outcomes and Measures/UNASSIGNED:Vital signs; use of supplemental oxygen; the presence of precipitated withdrawal, sedation, and respiratory depression; adverse events; length of stay; and hospitalization during and 24 hours after the ED visit were reported according to total sublingual buprenorphine dose (range, 2 to >28 mg). Results/UNASSIGNED:Among a total of 391 unique patients (median [interquartile range] age, 36 [29-48] years), representing 579 encounters, 267 (68.3%) were male and 170 were (43.5%) Black. Homelessness (88 patients [22.5%]) and psychiatric disorders (161 patients [41.2%]) were common. A high dose of sublingual buprenorphine (>12 mg) was administered by 54 unique clinicians during 366 (63.2%) encounters, including 138 doses (23.8%) greater than or equal to 28 mg. No cases of respiratory depression or sedation were reported. All 5 (0.8%) cases of precipitated withdrawal had no association with dose; 4 cases occurred after doses of 8 mg of buprenorphine. Three serious adverse events unrelated to buprenorphine were identified. Nausea or vomiting was rare (2%-6% of cases). The median (interquartile range) length of stay was 2.4 (1.6-3.75) hours. Conclusions and Relevance/UNASSIGNED:These findings suggest that high-dose buprenorphine induction, adopted by multiple clinicians in a single-site urban ED, was safe and well tolerated in patients with untreated OUD. Further prospective investigations conducted in multiple sites would enhance these findings.
PMID: 34264326
ISSN: 2574-3805
CID: 4938822

The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation

D'Onofrio, Gail; Hawk, Kathryn F; Herring, Andrew A; Perrone, Jeanmarie; Cowan, Ethan; McCormack, Ryan P; Dziura, James; Taylor, R Andrew; Coupet, Edouard; Edelman, E Jennifer; Pantalon, Michael V; Owens, Patricia H; Martel, Shara H; O'Connor, Patrick G; Van Veldhuisen, Paul; DeVogel, Nicholas; Huntley, Kristen; Murphy, Sean M; Lofwall, Michelle R; Walsh, Sharon L; Fiellin, David A
ED-INNOVATION (Emergency Department-INitiated bupreNOrphine VAlidaTION) is a Hybrid Type-1 Implementation-Effectiveness multisite emergency department (ED) study funded through The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM efforts to increase access to medications for opioid use disorder (OUD). We use components of Implementation Facilitation to enhance adoption of ED-initiated buprenorphine (BUP) at approximately 30 sites. Subsequently we compare the effectiveness of two BUP formulations, sublingual (SL-BUP) and 7-day extended-release injectable (CAM2038, XR-BUP) in a randomized clinical trial (RCT) of approximately 2000 patients with OUD on the primary outcome of engagement in formal addiction treatment at 7 days. Secondary outcomes assessed at 7 and 30 days include self-reported opioid use, craving and satisfaction, health service utilization, overdose events, and engagement in formal addiction treatment (30 days) and receipt of medications for OUD (at 7 and 30 days). A sample size of 1000 per group provides 90% power at the 2-sided significance level to detect a difference in the primary outcome of 8% and accommodates a 15% dropout rate. We will compare the cost effectiveness of the two treatments on the primary outcome using the incremental cost-effectiveness ratio. We will also conduct an ancillary study in approximately 75 patients experiencing minimal to no opioid withdrawal who will undergo XR-BUP initiation. If the ancillary study demonstrates safety, we will expand the eligibility criteria for the RCT to include individuals with minimal to no opioid withdrawal. The results of these studies will inform implementation of ED-initiated BUP in diverse EDs which has the potential to improve treatment access.
PMID: 33737199
ISSN: 1559-2030
CID: 4838282

Implementation facilitation to introduce and support emergency department-initiated buprenorphine for opioid use disorder in high need, low resource settings: protocol for multi-site implementation-feasibility study

McCormack, Ryan P; Rotrosen, John; Gauthier, Phoebe; D'Onofrio, Gail; Fiellin, David A; Marsch, Lisa A; Novo, Patricia; Liu, David; Edelman, E Jennifer; Farkas, Sarah; Matthews, Abigail G; Mulatya, Caroline; Salazar, Dagmar; Wolff, Jeremy; Knight, Randolph; Goodman, William; Hawk, Kathryn
BACKGROUND:For many reasons, the emergency department (ED) is a critical venue to initiate OUD interventions. The prevailing culture of the ED has been that substance use disorders are non-emergent conditions better addressed outside the ED where resources are less constrained. This study, its rapid funding mechanism, and accelerated timeline originated out of the urgent need to learn whether ED-initiated buprenorphine (BUP) with referral for treatment of OUD is generalizable, as well as to develop strategies to facilitate its adoption across a variety of ED settings and under real-world conditions. It both complements and uses methods adapted from Project ED Health (CTN-0069), a Hybrid Type 3 implementation-effectiveness study of using Implementation Facilitation (IF) to integrate ED-initiated BUP and referral programs. METHODS:ED-CONNECT (CTN 0079) was a three-site implementation study exploring the feasibility, acceptability, and impact of introducing ED-initiated BUP in rural and urban settings with high-need, limited resources, and different staffing structures. We used a multi-faceted approach to develop, introduce and iteratively refine site-specific ED clinical protocols and implementation plans for opioid use disorder (OUD) screening, ED-initiated BUP, and referral for treatment. We employed a participatory action research approach and use mixed methods incorporating data derived from abstraction of medical records and administrative data, assessments of recruited ED patient-participants, and both qualitative and quantitative inquiry involving staff from the ED and community, patients, and other stakeholders. DISCUSSION/CONCLUSIONS:This study was designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs previously not providing ED-initiated BUP, in communities in which this intervention is most needed: high need, low resource settings. TRIAL REGISTRATION/BACKGROUND:The study was prospectively registered on ClinicalTrials.gov (NCT03544112) on June 01, 2018: https://clinicaltrials.gov/ct2/show/NCT03544112 .
PMCID:7941881
PMID: 33750454
ISSN: 1940-0640
CID: 4822352

Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial

Regis, Amber; Meyers-Ohki, Sarah E; Mennenga, Sarah E; Greco, Peter P; Glisker, Richard; Kolaric, Rhonda; McCormack, Ryan P; Rapp, Richard C; Bogenschutz, Michael P
BACKGROUND:As the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap from acute ED care to longer-term treatment have shown limited efficacy for this population. Strength-based case management (SBCM) has shown strong effects on treatment linkage among patients with substance use disorders in other healthcare settings. This study aimed to investigate whether SBCM is an effective model for linking opioid-dependent ED patients with addiction treatment and pharmacotherapy. Here, we describe the implementation and challenges of adapting SBCM for the ED (SBCM-ED). Study rationale, design, and baseline characteristics are also described. METHODS:This study compared the effects of SBCM-ED to screening, assessment, and referral alone (SAR) on treatment linkage, substance use, and functioning. We recruited participants from a public hospital in NYC. Working alliance between case managers and participants and the feasibility of SBCM implementation were evaluated. Baseline data from the randomized sample were analyzed for group equivalency. Outcomes analyses are forthcoming. RESULTS:Three hundred adult participants meeting DSM-IV criteria for opioid dependence were randomly assigned to either SBCM, in which they received a maximum of six case management sessions within 90 days of enrollment, or SAR, in which they received a comprehensive referral list and pamphlet outlining drug use consequences. No significant differences were found between groups at baseline on demographic or substance use characteristics. All SAR participants and 92.6% of SBCM-ED participants initiated their assigned intervention. Over half of SBCM-ED first sessions occurred in the ED on the day of enrollment. Case managers developed a strong working alliance with SBCM-ED participants after just one session. CONCLUSION/CONCLUSIONS:Interventions that exceed SBIRT were accepted by an opioid-dependent patient population seen in an urban medical ED. At the time of study funding, this trial was one of the first to focus specifically on this population in this challenging setting. The successful implementation of SBCM demonstrates its adaptability to the ED and may serve as a potential model for EDs seeking to adopt an intervention that overcomes the barrier between the ED encounter and more intensive treatment. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT02586896 . Registered on 27 October 2015.
PMID: 32883337
ISSN: 1745-6215
CID: 4583492

Extended-release naltrexonewas feasible, acceptable, and reduced drinking in patients with alcohol use disorders who frequent the emergency department [Meeting Abstract]

McCormack, R P; Rotrosen, J; Wall, S P; Moran, Z; Goldfrank, L; Lee, J; Doran, K M; Shin, S; D'Onofrio, G
Purpose: Almost uniformly, patients with frequent Emergency Department (ED) use and severe alcohol use disorders (AUDs) do not receive alcohol pharmacotherapy and are excluded from research as they are difficult to engage and retain and suffer from myriad bio-psychosocial comorbidities. We assessed the feasibility and acceptability of initiating and continuing treatment with extended-release naltrexone (XR-NTX) as well as studying its effects in this challenging population and clinical setting.
Method(s): In this randomized, open-label study, ED patient-participants with > 4 ED visits and moderate- severe AUD were randomized (1:1) to XR-NTX and research assistant-delivered care management or treatment as usual enhanced by a one-time warm referral and motivation enhancement. XR-NTX was first administered during the index ED visit. Thereafter, participants could receive up to 11 additional doses at clinic visits with arrangements to allow unscheduled visits. Non-clinical research visits (both arms) were scheduled at 3, 6, and 12 months with a considerable date variation permitted and expected. Drinking was assessed via 30-day timeline followback with heavy drinking day (HDD) thresholds of 5 for males and 4 for females. Resuts: The 48 participants were aged 55.0 +/- 8.2, 88% male, 51% white, 79% homeless, and reported an average of 23.4 HDDs in the priormonth and 24.4 standard drinks/drinking day. Approximately 70%lacked reliable contact information. Research visit attendance was 70.8%, 77.1%, and 70.8%with a median time to first visit of 126 days [Interquartile Range: 89-242]. In the XR-NTX arm (N = 24), a total of 173 injections were administered with amean of 7.2 per participant; 20 (83%) participants received 2 or more injections, 14 (56%) received 6 or more injections, and 6 (24%) received 12 injections. There was a significantly greater decrease in HDDs per month among those receiving XR-NTX compared to those who did not: 15.3 (95%CI 9.7-21.0) and 9.6 (95%CI 1.5-17.6), respectively. Baseline rates were imputed for two missing participants in each arm.
Conclusion(s): Among this population whose complicated AUDs pose considerable challenges from clinical and research perspectives, initiating and continuing treatment with XR-NTX was feasible, acceptable, and demonstrated promising preliminary drinking outcomes. Additional sensitivity analyses and evaluation of other outcomes of interest are underway. Further study on a larger scale is warranted
EMBASE:632393612
ISSN: 1530-0277
CID: 4548232

Feasibility and impact of implementing buprenorphine initiation programs in three heterogenous rural and urban emergency departments [Meeting Abstract]

McCormack, R P; Rotrosen, J; D'Onofrio, G; Gauthier, P; Marsch, L A; Matthews, A; Mulatya, C; Edelman, E J; Farkas, S; Fiellin, D A; Goodman, W; Huntley, K; Knight, R; Liu, D; Meyers-Ohki, S; Novo, P; Shin, S -M; Wall, S P; Hawk, K
Background and Objectives: To rapidly develop, implement, and evaluate emergency department (ED) clinical protocols for initiation of buprenorphine (E
EMBASE:632418168
ISSN: 1553-2712
CID: 4547932

EXTENDED-RELEASE NALTREXONE WAS FEASIBLE, ACCEPTABLE, AND REDUCED DRINKING IN PATIENTS WITH ALCOHOL USE DISORDERS WHO FREQUENT THE EMERGENCY DEPARTMENT [Meeting Abstract]

McCormack, R. P.; Rotrosen, J.; Wall, S. P.; Moran, Z.; Goldfrank, L.; Lee, J.; Doran, K. M.; Shin, S.; D\Onofrio, G.
ISI:000540372300600
ISSN: 0145-6008
CID: 4573282

Emergency department-initiated buprenorphine in rural and low resource emergency departments [Meeting Abstract]

Hawk, K; D'Onofrio, G; Fiellin, D; Rotrosen, J; Edelman, E J; Gauthier, P; Novo, P; Marsch, L A; Farkas, S; Knight, R; Goodman, W; Coupet, E; Toledo, N; McCormack, R P
Background: Patients with opioid use disorder (OUD) have improved outcomes on buprenorphine (BUP) and are twice as likely to be in treatment if BUP is initiated in the Emergency Department (ED) compared with standard referral. Our objective is to assess staff readiness for ED-initiated BUP with referral in highneed, low-resource community and academic EDs in New Hampshire and Manhattan.
Method(s): As part of an implementation study, in summer 2018, we conducted a mixed-methods formative evaluation using the modified Organizational Readiness to Change Assessment (ORCA) and rulers of readiness to begin ED-BUP on a scale of 0 (not) to 10 (completely), in EDs of one critical access hospital, one community hospital with urban/rural catchment, and one academic public safety-net hospital. ORCAs were administered electronically prior to inperson focus groups with ED physicians, PA/APRNs, nurses, social workers, and community providers. ORCAs and rulers were compared across sites and between EDs and the community providers. We conducted focus groups guided by an implementation framework to identify barriers and facilitators to the implementation of ED-BUP at each site. Findings were reported back to stakeholders, and used to develop site-specific clinical protocols and implementation strategies, along with education and resources designed to enhance uptake of ED-BUP at each site.
Result(s): ORCA completion rates at each site were 32%, 52%, and 17%. The ORCA showed that ED staff at two sites were ambivalent as to whether ED-BUP will improve treatment follow-up; one site agreed. ED staff and community providers reported respective readiness for ED-BUP with referral at each site of 3.5 (N=15) and 6.7 (N=36); 2.0 (N=11) and 6.3(N=28); 3.5 (N=28) and 9.3 (N=6). Nine focus groups of 36 stakeholders identified several barriers (lack of knowledge/experience with BUP, workflow integration, increased time/patient burden, and limited knowledge of local treatment options) and facilitators (improved patient care, a sense of moral imperative, and local champions/leadership buy-in).
Conclusion(s): A mixed-methods formative evaluation with facilitation and stakeholder input identified ambivalence in ED staff, as well as barriers and facilitators, including specific opportunities for education and facilitation, which may enhance site-specific implementation of ED-initiated BUP
EMBASE:627697414
ISSN: 1553-2712
CID: 3900162

Implementing Emergency Department-Initiated Buprenorphine in Low-Resource, High-Need Settings [Meeting Abstract]

McCormack, R. P.; Hawk, K.; D\Onofrio, G.; Rotrosen, J.; Gauthier, P.; Edelman, E. E. J.; Fiellin, D.; Novo, P.; Marsch, L.; Knight, R.; Goodman, W.
ISI:000489265600156
ISSN: 0196-0644
CID: 4155952