QuestionDoes 7-day extended-release injectable buprenorphine compared with sublingual buprenorphine improve treatment engagement at 7 days?FindingsIn this multicenter randomized trial of 1994 adult patients presenting to the emergency department with untreated opioid use disorder and a Clinical Opiate Withdrawal Scale (COWS) score of 4 or higher, 40.5% in the extended-release group and 38.5% in the sublingual buprenorphine group were in treatment at 7 days, demonstrating no significant difference between groups.MeaningA 7-day extended-release injectable preparation of buprenorphine does not improve treatment engagement. ImportanceExtended-release injectable buprenorphine may expand the reach of initiating medications for opioid use disorder in high-risk and hard-to-reach individuals who visit the emergency department (ED) and can be administered in low levels of withdrawal.ObjectiveTo compare the effect of ED-initiated 7-day extended-release injectable buprenorphine vs sublingual buprenorphine on treatment engagement at 7 days.Design, Setting, and ParticipantsMulticenter randomized clinical trial enrolling adult patients presenting to the ED with untreated opioid use disorder and a Clinical Opiate Withdrawal Scale (COWS) score of 4 or higher across 29 EDs in the US from July 12, 2020, to August 21, 2024. Final follow-up was completed on October 24, 2024.InterventionsPatients were randomized to receive a 24-mg injection of extended-release buprenorphine (equivalent to 16 mg/d) or sublingual buprenorphine, which included either self-administration instructions if the COWS score was less than 8 or administration of 8 mg of sublingual buprenorphine in the ED if the COWS score was 8 or higher. All sublingual buprenorphine group patients received a 7-day prescription for 16 mg/d. Both groups were provided referral for ongoing medication with a scheduled appointment within 7 days.Main Outcomes and MeasuresEngagement in opioid use disorder treatment on day 7 was the primary outcome. Secondary outcomes included engagement at 30 days, precipitated withdrawal and overdose events, craving scores, days of illicit opioid use, and patient satisfaction with treatment.ResultsAmong 2000 patients randomized, 6 who were enrolled twice were excluded, resulting in 991 in the extended-release group and 1003 in the sublingual group. The median age was 37 (IQR, 30-47) years, 68% were male, 31% had an initial COWS score of 4 to 7, and 76% tested positive for fentanyl. The adjusted proportion of engagement in opioid use disorder treatment at 7 days was 40.5% with extended-release buprenorphine vs 38.5% with sublingual buprenorphine (adjusted difference, 1.6%; 95% CI, -2.8% to 6.0%). Engagement at 30 days was similar, with adjusted proportions of 43.8% with extended-release buprenorphine vs 44.9% with sublingual buprenorphine (adjusted difference, -1.5%; 95% CI, -6.2% to 3.2%). Precipitated withdrawal was rare: 6 (0.6%) with extended-release buprenorphine and 8 (0.8%) with sublingual buprenorphine. Overdose events within 30 days occurred in 18 participants (2.3%) in each group. Patients receiving extended-release buprenorphine reported lower mean craving scores at 7 days vs those receiving sublingual buprenorphine (scale, 0-100; mean score, 26.5 vs 30.2, respectively; adjusted mean difference, -3.85; 95% CI, -7.08 to -0.63), fewer days of illicit opioid use in the past 7 days (adjusted ratio of means, 0.77; 95% CI, 0.68-0.95), and better treatment satisfaction scores (scale, 1-5; adjusted mean difference, 0.13; 95% CI, 0.01-0.25).Conclusions and RelevanceNo difference was detected in opioid use disorder treatment engagement on day 7 between the 7-day extended-release and sublingual buprenorphine groups. Both buprenorphine formulations were well tolerated; precipitated withdrawal was rare despite a high prevalence of fentanyl.Trial RegistrationClinicalTrials.gov Identifier: NCT04225598 This randomized clinical trial assesses the effect of emergency department (ED)-initiated 7-day extended-release injectable buprenorphine vs sublingual buprenorphine on treatment engagement at 7 days among patients with opioid use disorder.

Importance:Extended-release injectable buprenorphine may expand the reach of initiating medications for opioid use disorder in high-risk and hard-to-reach individuals who visit the emergency department (ED) and can be administered in low levels of withdrawal. Objective:To compare the effect of ED-initiated 7-day extended-release injectable buprenorphine vs sublingual buprenorphine on treatment engagement at 7 days. Design, Setting, and Participants:Multicenter randomized clinical trial enrolling adult patients presenting to the ED with untreated opioid use disorder and a Clinical Opiate Withdrawal Scale (COWS) score of 4 or higher across 29 EDs in the US from July 12, 2020, to August 21, 2024. Final follow-up was completed on October 24, 2024. Interventions:Patients were randomized to receive a 24-mg injection of extended-release buprenorphine (equivalent to 16 mg/d) or sublingual buprenorphine, which included either self-administration instructions if the COWS score was less than 8 or administration of 8 mg of sublingual buprenorphine in the ED if the COWS score was 8 or higher. All sublingual buprenorphine group patients received a 7-day prescription for 16 mg/d. Both groups were provided referral for ongoing medication with a scheduled appointment within 7 days. Main Outcomes and Measures:Engagement in opioid use disorder treatment on day 7 was the primary outcome. Secondary outcomes included engagement at 30 days, precipitated withdrawal and overdose events, craving scores, days of illicit opioid use, and patient satisfaction with treatment. Results:Among 2000 patients randomized, 6 who were enrolled twice were excluded, resulting in 991 in the extended-release group and 1003 in the sublingual group. The median age was 37 (IQR, 30-47) years, 68% were male, 31% had an initial COWS score of 4 to 7, and 76% tested positive for fentanyl. The adjusted proportion of engagement in opioid use disorder treatment at 7 days was 40.5% with extended-release buprenorphine vs 38.5% with sublingual buprenorphine (adjusted difference, 1.6%; 95% CI, -2.8% to 6.0%). Engagement at 30 days was similar, with adjusted proportions of 43.8% with extended-release buprenorphine vs 44.9% with sublingual buprenorphine (adjusted difference, -1.5%; 95% CI, -6.2% to 3.2%). Precipitated withdrawal was rare: 6 (0.6%) with extended-release buprenorphine and 8 (0.8%) with sublingual buprenorphine. Overdose events within 30 days occurred in 18 participants (2.3%) in each group. Patients receiving extended-release buprenorphine reported lower mean craving scores at 7 days vs those receiving sublingual buprenorphine (scale, 0-100; mean score, 26.5 vs 30.2, respectively; adjusted mean difference, -3.85; 95% CI, -7.08 to -0.63), fewer days of illicit opioid use in the past 7 days (adjusted ratio of means, 0.77; 95% CI, 0.68-0.95), and better treatment satisfaction scores (scale, 1-5; adjusted mean difference, 0.13; 95% CI, 0.01-0.25). Conclusions and Relevance:No difference was detected in opioid use disorder treatment engagement on day 7 between the 7-day extended-release and sublingual buprenorphine groups. Both buprenorphine formulations were well tolerated; precipitated withdrawal was rare despite a high prevalence of fentanyl. Trial Registration:ClinicalTrials.gov Identifier: NCT04225598.

INTRODUCTION:Treatment of opioid use disorder (OUD) with buprenorphine is safe and effective, but Emergency Department-initiated buprenorphine (ED BUP) uptake is suboptimal. As part of a randomized clinical trial (RCT), we evaluated Implementation Facilitation (IF)'s impact on EDs' readiness to provide ED BUP. METHODS:From February 2020 to May 2024, we surveyed 31 ED Medical Directors (MDs) and site-Principal Investigators (PIs) across 33 Emergency Department-INitiated bupreNOrphine VAlidaTION (ED-INNOVATION) sites (29 of which proceeded to RCT enrollment) at three time points: pre-IF (baseline), early-IF (pre-enrollment), and late-IF (post-enrollment). We collected 10-point Likert scale ratings and performed linear regression modeling and correlation analysis to evaluate relationships between readiness, barriers, facilitators, and readiness changes over time. RESULTS:Across 31 responses for the three time points, mean readiness increased pre-IF to early-IF (6.29 vs. 8.23, p < 0.0001) and pre-IF to late-IF (6.29 vs. 8.39, p < 0.0001). We observed decreases in 13/15 barriers and increases in 13/19 facilitators. When examining relationships between changes in readiness, barriers, and facilitators, the strongest relationships were follow-up treatment availability (r = 0.64, p = 0.0001), prescribing practices knowledge (r = -0.64, p = 0.001); insurance coverage (r = -0.52, p = 0.002); nursing support (r = -0.48, p = 0.01); and knowledge about addiction and its treatment (r = 0.47, p = 0.007); weak relationships were length of stay impact (r = 0.02, p = 0.92), trained clinicians (r = 0.02, p = 0.91), and social complexity (r = -0.10, p = 0.60). CONCLUSIONS:IF was associated with improved readiness, decreases in barriers and an increase in facilitators of ED BUP. When faced with limited resources, these findings can help inform prioritization of addressable barriers and facilitators to improve readiness for ED BUP.

Importance:Buprenorphine is an effective yet underused treatment for opioid use disorder (OUD). Objective:To evaluate the feasibility (acceptability, tolerability, and safety) of 7-day injectable extended-release buprenorphine in patients with minimal to mild opioid withdrawal. Design, Setting, and Participants:This nonrandomized trial comprising 4 emergency departments in the Northeast, mid-Atlantic, and Pacific geographic areas of the US included adults aged 18 years or older with moderate to severe OUD and Clinical Opiate Withdrawal Scale (COWS) scores less than 8 (minimal to mild), in which scores range from 0 to 7, with higher scores indicating increasing withdrawal. Exclusion criteria included methadone-positive urine, pregnancy, overdose, or required admission. Outcomes were assessed at baseline, daily for 7 days by telephone surveys, and in person at 7 days. Patient recruitment occurred between July 13, 2020, and May 25, 2023. Intervention:Injection of a 24-mg dose of a weekly extended-release formulation of buprenorphine (CAM2038) and referral for ongoing OUD care. Main Outcomes and Measures:Primary feasibility outcomes included the number of patients who (1) experienced a 5-point or greater increase in the COWS score or (2) transitioned to moderate or greater withdrawal (COWS score ≥13) within 4 hours of extended-release buprenorphine or (3) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. Secondary outcomes included injection pain, satisfaction, craving, use of nonprescribed opioids, adverse events, and engagement in OUD treatment. Results:A total of 100 adult patients were enrolled (mean [SD] age, 36.5 [8.7] years; 72% male). Among the patients, 10 (10.0% [95% CI, 4.9%-17.6%]) experienced a 5-point or greater increase in COWS and 7 (7.0% [95% CI, 2.9%-13.9%]) transitioned to moderate or greater withdrawal within 4 hours, and 2 (2.0% [95% CI, 0.2%-7.0%]) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. A total of 7 patients (7.0% [95% CI, 2.9%-13.9%]) experienced precipitated withdrawal within 4 hours of extended-release buprenorphine, which included 2 of 63 (3.2%) with a COWS score of 4 to 7 and 5 of 37 (13.5%) with a COWS score of 0 to 3. Site pain scores (based on a total pain score of 10, in which 0 indicated no pain and 10 was the worst possible pain) after injection were low immediately (median, 2.0; range, 0-10.0) and after 4 hours (median, 0; range, 0-10.0). On any given day among those who responded, between 29 (33%) and 31 (43%) patients reported no cravings and between 59 (78%) and 75 (85%) reported no use of opioids; 57 patients (60%) reported no days of opioid use. Improving privacy (62%) and not requiring daily medication (67%) were deemed extremely important. Seventy-three patients (73%) were engaged in OUD treatment on day 7. Five serious adverse events occurred that required hospitalization, of which 2 were associated with medication. Conclusions and Relevance:This nonrandomized trial of the feasibility of a 7-day buprenorphine injectable in patients with minimal to mild opioid withdrawal (COWS scores, 0-7) found the formulation to be acceptable, well tolerated, and safe in those with COWS scores of 4 to 7. This new medication formulation could substantially increase the number of patients with OUD receiving buprenorphine. Trial Registration:ClinicalTrials.gov Identifier: NCT04225598.

Opioid use disorder and opioid overdose deaths are a major public health crisis, yet highly effective evidence-based treatments are available that reduce morbidity and mortality. One such treatment, buprenorphine, can be initiated in the emergency department (ED). Despite evidence of efficacy and effectiveness for ED-initiated buprenorphine, universal uptake remains elusive. On November 15 and 16, 2021, the National Institute on Drug Abuse Clinical Trials Network convened a meeting of partners, experts, and federal officers to identify research priorities and knowledge gaps for ED-initiated buprenorphine. Meeting participants identified research and knowledge gaps in 8 categories, including ED staff and peer-based interventions; out-of-hospital buprenorphine initiation; buprenorphine dosing and formulations; linkage to care; strategies for scaling ED-initiated buprenorphine; the effect of ancillary technology-based interventions; quality measures; and economic considerations. Additional research and implementation strategies are needed to enhance adoption into standard emergency care and improve patient outcomes.

STUDY OBJECTIVE:We hypothesized that implementation facilitation would enable us to rapidly and effectively implement emergency department (ED)-initiated buprenorphine programs in rural and urban settings with high-need, limited resources and dissimilar staffing structures. METHODS:This multicenter implementation study employed implementation facilitation using a participatory action research approach to develop, introduce, and refine site-specific clinical protocols for ED-initiated buprenorphine and referral in 3 EDs not previously initiating buprenorphine. We assessed feasibility, acceptability, and effectiveness by triangulating mixed-methods formative evaluation data (focus groups/interviews and pre/post surveys involving staff, patients, and stakeholders), patients' medical records, and 30-day outcomes from a purposive sample of 40 buprenorphine-receiving patient-participants who met research eligibility criteria (English-speaking, medically stable, locator information, nonprisoners). We estimated the primary implementation outcome (proportion receiving ED-initiated buprenorphine among candidates) and the main secondary outcome (30-day treatment engagement) using Bayesian methods. RESULTS:Within 3 months of initiating the implementation facilitation activities, each site implemented buprenorphine programs. During the 6-month programmatic evaluation, there were 134 ED-buprenorphine candidates among 2,522 encounters involving opioid use. A total of 52 (41.6%) practitioners initiated buprenorphine administration to 112 (85.1%; 95% confidence interval [CI] 79.7% to 90.4%) unique patients. Among 40 enrolled patient-participants, 49.0% (35.6% to 62.5%) were engaged in addiction treatment 30 days later (confirmed); 26 (68.4%) reported attending one or more treatment visits; there was a 4-fold decrease in self-reported overdose events (odds ratio [OR] 4.03; 95% CI 1.27 to 12.75). The ED clinician readiness increased by a median of 5.02 (95% CI: 3.56 to 6.47) from 1.92/10 to 6.95/10 (n(pre)=80, n(post)=83). CONCLUSIONS:The implementation facilitation enabled us to effectively implement ED-based buprenorphine programs across heterogeneous ED settings rapidly, which was associated with promising implementation and exploratory patient-level outcomes.

As the opioid overdose epidemic escalates, there is an urgent need for treatment innovations to address both patient and clinician barriers when initiating buprenorphine in the emergency department (ED). These include insurance status, logistical challenges such as the ability to fill a prescription and transportation, concerns regarding diversion, and availability of urgent referral sites. Extended-release buprenorphine (XR-BUP) preparations such as a new 7-day injectable could potentially solve some of these issues. We describe the pharmacokinetics of a new 7-day XR-BUP formulation and the feasibility of its use in the ED setting. We report our early experiences with this medication (investigational drug CAM2038), in the context of an ongoing clinical trial entitled Emergency Department-Initiated BUP VAlidaTION (ED INNOVATION), to inform emergency clinicians as they consider incorporating this medication into their practice. The medication was approved by the European Medicines Agency in 2018 and the U.S. Food and Drug Administration in 2023 for those 18 years or older for the treatment of moderate to severe opioid use disorder (OUD). We report our experience with approximately 800 ED patients with OUD who received the 7-day XR-BUP preparation in the ED between June 2020 and July 2023.

Background: Opioid overdose deaths in 2021 were the highest ever, driven by fentanyl and polysubstance use. Objective: The aim of the study was to characterize drug use, assessed by urine drug screens (UDSs), in patients with untreated opioid use disorder (OUD) presenting to 28 emergency departments (EDs) nationally and by region. Methods: We analyzed UDSs from patients enrolled in the CTN-0099 ED-INNOVATION (Emergency Department -Initiated Buprenorphine Validation) trial between July 12, 2020 and March 9, 2022. Participants were adult ED patients with OUD not engaged in addiction treatment with a UDS positive for an opioid, but negative for methadone. Sites were divided into "East" and "West" regions. Results: A UDS was available for all 925 enrolled participants, 543 from East and 382 from West. Fentanyl was in 702 specimens (76%) (n = 485 [89%] East vs. n = 217 [57%] West; p < 0.01) and was the only opioid in 269 (29%). After fentanyl, the most common opioids were morphine (presumably heroin; n = 411 [44%]; n = 192 [35%] East vs. n = 219 [57%] West; p < 0.01) and buprenorphine (n = 329 [36%]; n = 186 [35%] East vs. n = 143 [37%] West; p = 0.32). The most common drugs found with opioids were stimulants (n = 545 [59%]), tetrahydrocannabinol (n = 417 [45%]), and benzo-diazepines (n = 151 [16%]). Amphetamine-type stimulants were more common in West (n = 209 [55%] vs. East (n = 125 [23%]). Cocaine was more common in East (n = 223 [41%]) vs. West (n = 82 [21%]). The presence of multiple drugs was common (n = 759 [82%]). Conclusions: Most participants had UDS specimens containing multiple substances; a high proportion had fentanyl, stimulants, and buprenorphine. Regional differences were noted. Given the increased risk of death with fentanyl and polysubstance use, ED providers should be providing risk reduction counseling, treatment, and referral. (c) 2023 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )

BACKGROUND:Housing insecurity is prevalent among emergency department (ED) patients. Despite a surge of interest in screening for patients' social needs including housing insecurity, little research has examined ED social needs interventions. We worked together with government and community partners to develop and pilot test a homelessness prevention intervention targeted to ED patients with drug or unhealthy alcohol use. METHODS:We approached randomly sampled patients at an urban public hospital ED, May to August 2019. Adult patients were eligible if they were medically stable, not incarcerated, spoke English, had unhealthy alcohol or any drug use, and were not currently homeless but screened positive for risk of future homelessness using a previously developed risk screening tool. Participants received a three-part intervention: (1) brief counseling and referral to treatment for substance use delivered through a preexisting ED program; (2) referral to Homebase, an evidence-based community homelessness prevention program; and (3) up to three troubleshooting phone calls by study staff. Participants completed surveys at baseline and 6 months. RESULTS:Of 2183 patients screened, 51 were eligible and 40 (78.4%) participated; one later withdrew, leaving 39 participants. Participants were diverse in age, gender, race, and ethnicity. Of the 32 participants reached at 6 months, most said it was very or extremely helpful to talk to someone about their housing situation (n = 23, 71.9%) at the baseline ED visit. Thirteen (40.6%) said their housing situation had improved in the past 6 months and 16 (50.0%) said it had not changed. Twenty participants (62.5%) had made contact with a Homebase office. Participants shared ideas of how to improve the intervention. CONCLUSIONS:This pilot intervention was feasible and well received by participants though it required a large amount of screening to identify potentially eligible patients. Our findings will inform a larger future trial and may be informative for others seeking to develop similar interventions.

Importance:Emergency departments (EDs) are increasingly initiating treatment for patients with untreated opioid use disorder (OUD) and linking them to ongoing addiction care. To our knowledge, patient perspectives related to their ED visit have not been characterized and may influence their access to and interest in OUD treatment.Objective:To assess the experiences and perspectives regarding ED-initiated health care and OUD treatment among US patients with untreated OUD seen in the ED.Design, Setting, and Participants:This qualitative study, conducted as part of 2 studies (Project ED Health and ED-CONNECT), included individuals with untreated OUD who were recruited during an ED visit in EDs at 4 urban academic centers, 1 public safety net hospital, and 1 rural critical access hospital in 5 disparate US regions. Focus groups were conducted between June 2018 and January 2019.Main Outcomes and Measures:Data collection and thematic analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework with evidence (perspectives on ED care), context (ED), and facilitation (what is needed to promote change) elements.Results:A total of 31 individuals (mean [SD] age, 43.4 [11.0] years) participated in 6 focus groups. Twenty participants (64.5%) identified as male and most 13 (41.9%) as White; 17 (54.8%) reported being unemployed. Themes related to evidence included patients' experience of stigma and perceived minimization of their pain and medical problems by ED staff. Themes about context included the ED not being seen as a source of OUD treatment initiation and patient readiness to initiate treatment being multifaceted, time sensitive, and related to internal and external patient factors. Themes related to facilitation of improved care of patients with OUD seen in the ED included a need for on-demand treatment and ED staff training.Conclusions and Relevance:In this qualitative study, patients with OUD reported feeling stigmatized and minimized when accessing care in the ED and identified several opportunities to improve care. The findings suggest that strategies to address stigma, acknowledge and treat pain, and provide ED staff training should be implemented to improve ED care for patients with OUD and enhance access to life-saving treatment.

Background: Homelessness and substance use are intricately related, and both are prevalent among emergency department (ED) patients. This study examined the longitudinal association of substance use characteristics with future homeless shelter entry among ED patients with any drug use or unhealthy alcohol use. Methods: We present results from a longitudinal cohort study of public hospital ED patients who screened positive for drug use or unhealthy alcohol use and who were not homeless at their baseline (index) ED visit. The primary outcome was homeless shelter entry within 12 months of baseline, ascertained in city homeless shelter administrative data. Primary independent variables of interest were alcohol use severity (AUDIT), drug use severity (DAST-10), and types of drugs used, as reported on baseline survey questionnaires. Results:Analyses included 1,210 ED patients. By 12 months following the baseline ED visit, 114 (9.4%) had entered a homeless shelter. Among patients with the most severe problems related to drug use (DAST-10 score 9–10), 40.9% entered a shelter within 12 months. Past shelter use was the strongest predictor of future shelter entry; once adjusting for historic shelter use the relationship of AUDIT and DAST-10 scores with future shelter entry was no longer statistically significant in multivariable models. Conclusions: ED patients with past year drug use or unhealthy alcohol use had relatively high likelihood of future shelter entry. Risk for homelessness should be addressed in future interventions with this population. Findings illustrate the complexity of relationships between substance use and homelessness.

Background: Despite the existence of effective pharmacotherapies, rates of opioid use disorder and opioid overdose deaths have continued to increase. Emergency department (ED) visits provide an important opportunity to engage in treatment patients with untreated opioid use disorder (OUD). Case management implemented in other settings is effective in linking those with opioid and other drug use disorders to longer-term treatment, but research has not established its efficacy in the ED. Here we report the results of a trial of Strengths-Based Case Management (SBCM) for people with untreated OUD who are identified during ED visits, with the primary goal of linking them to pharmacologic treatment. Methods: The study identified patients with untreated OUD during a treatment episode at a large urban ED. The study randomly assigned three hundred participants in 1:1 ratio to receive SBCM or screening, assessment, and referral (SAR) to OUD treatment. Those assigned to SBCM received up to six sessions of SBCM with the primary goal of linkage to treatment. Primary outcomes were initiation of treatment and engagement in pharmacotherapy for OUD. The study defined a "successful outcome " for opioid use as a 3-month urine negative for illicit opioids and no more than 2 days of self-reported opioid misuse in the 4 weeks prior to the 3-month interview. Results: Rates of treatment initiation were not significantly different in the SBCM and SAR groups (57.4% vs. 49.7%, respectively, p > 0.05), nor did engagement in pharmacotherapy differ significantly between groups (p > 0.05). During the 90 days following the index ED visit, SBCM and SAR participants engaged in pharmacotherapy for a mean of 21.8% (SD = 35.1%) versus 17.7% (SD = 31.0%) of days, respectively. Likewise, no significant difference occurred between groups in rates of "successful opioid use outcome " as defined a priori (p > 0.05), although self-reported opioid use over the entire 6-month follow-up period was lower in the SBCM group (10.8 vs. 13.4 days/month, p = 0.042). Conclusions: SBCM-ED did not improve OUD treatment initiation and engagement in this ED study. Although these findings do not necessarily generalize to all EDs, other approaches, such as direct referral or initiation of treatment in the ED, have considerable empirical support, and should be implemented where they are feasible.

Objectives: We aim to assess the influence of COVID-19 on the social needs of emergency department (ED) patients, and assess patients' access to social services.Methods: We conducted a cross-sectional survey of 175 purposively sampled adult ED patients.Results: Approximately half of participants stated that COVID-19 negatively impacted their social needs with statistically significant differences observed for race, ethnicity, and insurance status. Many participants did not know of available social services, and a majority welcomed assistance from the ED.Conclusion: This study suggests that unmet social needs have risen because of COVID-19, and EDs may be positioned to identify and assist affected patients.

STUDY 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: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.

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.

Background Emergency department (ED) patients commonly experience both substance use and homelessness, and social relationships impact each in varied ways not fully captured by existing quantitative research. This qualitative study examines how social relationships can precipitate or ameliorate homelessness and the connection (if any) between substance use and social relationships among ED patients experiencing homelessness. Methods As part of a broader study to develop ED-based homelessness prevention interventions, we conducted in-depth interviews with 25 ED patients who used alcohol or drugs and had recently become homeless. We asked patients about the relationship between their substance use and homelessness. Interviews were recorded, transcribed, and coded line-by-line by investigators. Final codes formed the basis for thematic analysis through consensus discussions. Results Social relationships emerged as focal points for understanding the four major themes related to the intersection of homelessness and substance use: (1) Substance use can create strain in relationships; (2) Help is there until it's not; (3) Social relationships can create challenges contributing to substance use; and (4) Reciprocal relationship of substance use and isolation. Sub-themes were also identified and described. Conclusions The association between substance use and homelessness is multifaceted and social relationships are a complex factor linking the two. Social relationships are often critical for homelessness prevention, but they are impacted by and reciprocally affect substance use. ED-based substance use interventions should consider the high prevalence of homelessness and the impact of social relationships on the interaction between homelessness and substance use.

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 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: The study was prospectively registered on ClinicalTrials.gov (NCT03544112) on June 01, 2018: https://clinicaltrials.gov/ct2/show/NCT03544112 .

Importance: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: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: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: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: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: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: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.