Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial.

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.

Utilization of long-acting injectable monthly depot buprenorphine for opioid use disorder (OUD) in Kentucky, before and after COVID-19 related buprenorphine access policy changes.

INTRODUCTION: Long-acting injectable buprenorphine (LAI-bup) formulations have advantages over transmucosal buprenorphine (TM-bup), but barriers may limit their utilization. Several policies shifted during the COVID-19 pandemic to promote buprenorphine access. The federal government expanded telemedicine treatment for opioid use disorder and Kentucky (KY) Medicaid lifted prior authorization requirements (PAs) for LAI-bup (i.e., Sublocade®). This retrospective cohort study evaluated changes in LAI-bup access, utilization, and retention before and after these policy changes in KY. METHODS: Individual-level TM-bup and LAI-bup dispensing record data from KY's prescription drug monitoring program examined LAI-bup utilization and retention, without a >30-day gap in coverage, for patients starting a new episode of LAI-bup treatment. Two key time periods were examined: pre-policy changes (Apr 1, 2019 - Dec 31, 2019) and post-policy changes (Apr 1, 2020 - Dec 31, 2020). Data on PA requests among Medicaid managed care organizations and availability of LAI-bup Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies were also obtained. A multivariable Cox proportional hazard regression model analysis compared pre- versus post-policy period treatment discontinuation. RESULTS: The number of patients initiating LAI-bup increased from 211 to 481 over the two periods. By the end of the post-policy period, 24.3 % of eligible patients were retained on LAI-bup, versus 12.5 % in the pre-policy change period. The adjusted hazard ratio, comparing discontinuation during the post- versus pre-policy change periods, was 0.70 (95 % confidence interval: 0.55-0.89). There were also more REMS-certified pharmacies and providers in the post-policy change period. CONCLUSIONS: LAI-bup access, utilization, and retention increased after several policy changes.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.

Higher First 30-Day Dose of Buprenorphine for Opioid Use Disorder Treatment Is Associated With Decreased Mortality.

OBJECTIVE: Buprenorphine is a medication for opioid use disorder that reduces mortality. This study aims to investigate the less well-understood relationship between the dose in the early stages of treatment and the subsequent risk of death. METHODS: We used Kentucky prescription monitoring data to identify adult Kentucky residents initiating transmucosal buprenorphine medication for opioid use disorder (January 2017 to November 2019). Average daily buprenorphine dose for days covered in the first 30 days of treatment was categorized as ≤8 mg, >8 to ≤16 mg, and >16 mg. Patients were followed for 365 days after the first 30 days of buprenorphine treatment. Endpoints were opioid-involved overdose death and death from other causes. Causes and dates of death were obtained using Kentucky death certificate records. Associations were evaluated using multivariable Fine and Gray models adjusting for patient baseline characteristics. RESULTS: In the cohort of 49,857 patients, there were 227 opioid-involved overdose deaths and 459 deaths from other causes. Compared with ≤8 mg, the adjusted subdistribution hazard ratio (aSHR) of opioid-involved overdose death decreased by 55% (aSHR, 0.45; 95% confidence interval [CI], 0.34-0.60) and 64% (aSHR, 0.36; 95% CI, 0.25-0.52) for patients receiving doses of >8 to ≤16 mg and >16 mg, respectively. The incidence of death from other causes was lower in patients receiving >8 to ≤16 mg (aSHR, 0.78; 95% CI, 0.62-0.98) and >16 mg (aSHR, 0.62; 95% CI, 0.47-0.80) versus ≤8 mg dose. CONCLUSIONS: Higher first 30-day buprenorphine doses were associated with reduced opioid-involved overdose death and death from other causes, supporting benefit of higher dosing in reducing mortality.

Predictors of engagement in screening for a hepatitis C virus (HCV) treatment trial in a rural Appalachian community.

An HCV treatment trial was initiated in September 2019 to address the opioid/hepatitis C virus (HCV) syndemic in rural Kentucky. The focus of the current analysis is on participation in diagnostic screening for the trial. Initial eligibility (≥18 years of age, county resident) was established by phone followed by in-person HCV viremia testing. 900 rural residents met the inclusion criteria and comprised the analytic sample. Generalized linear models were specified to estimate the relative risk of non-attendance at the in-person visit determining HCV eligibility. Approximately one-quarter (22.1%) of scheduled participants were no-shows. People who inject drugs were no more likely than people not injecting drugs to be a no-show; however, participants ≤35 years of age were significantly less likely to attend. While the median time between phone screening and scheduled in-person screening was only 2 days, each additional day increased the odds of no-show by 3% (95% confidence interval: 2%-3%). Finally, unknown HCV status predicted no-show even after adjustment for age, gender, days between screenings and injection status. We found that drug injection did not predict no-show, further justifying expanded access to HCV treatment among people who inject drugs. Those 35 years and younger were more likely to no-show, suggesting that younger individuals may require targeted strategies for increasing testing and treatment uptake. Finally, streamlining the treatment cascade may also improve outcomes, as participants in the current study were more likely to attend if there were fewer days between phone screening and scheduled in-person screening.

The development of a recovery coaching training curriculum to facilitate linkage to and increase retention on medications for opioid use disorder.

Introduction: Medication treatment for opioid use disorder (MOUD) decreases opioid overdose risk and is the standard of care for persons with opioid use disorder (OUD). Recovery coach (RC)-led programs and associated training curriculums to improve outcomes around MOUD are limited. We describe our comprehensive training curriculum including instruction and pedagogy for novel RC-led MOUD linkage and retention programs and report on its feasibility. Methods­pedagogy and training development: The Kentucky HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) created the Linkage and Retention RC Programs with a local recovery community organization, Voices of Hope-Lexington. RCs worked to reduce participant barriers to entering or continuing MOUD, destigmatize and educate on MOUD and harm reduction (e.g., safe injection practices), increase recovery capital, and provide opioid overdose education with naloxone distribution (OEND). An extensive hybrid (in-person and online, both synchronous and asynchronous), inclusive learning-focused curriculum to support the programs (e.g., motivational interviewing sessions, role plays, MOUD competency assessment, etc.,) was created to ensure RCs developed the necessary skills and could demonstrate competency before deployment in the field. The curriculum, pedagogy, learning environment, and numbers of RCs trained and community venues receiving a trained RC are reported, along with interviews from three RCs about the training program experience. Results: The curriculum provides approximately 150 h of training to RCs. From December 2020 to February 2023, 93 RCs and 16 supervisors completed the training program; two were unable to pass a final competency check. RCs were deployed at 45 agencies in eight Kentucky HCS counties. Most agencies (72%) sustained RC services after the study period ended through other funding sources. RCs interviewed reported that the training helped them better explain and dispel myths around MOUD. Conclusion: Our novel training and MOUD programs met a current unmet need for the RC workforce and for community agencies. We were able to train and deploy RCs successfully in these new programs aimed at saving lives through improving MOUD linkage and retention. This paper addresses a need to enhance the training requirements around MOUD for peer support specialists.

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial.

Importance: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. Objective: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. Design, Setting, and Participants: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. Intervention: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. Main Outcomes and Measures: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. Results: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). Conclusions and Relevance: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.

Extended-release Buprenorphine Administered at Discharge in Hospitalized Persons With Opioid Use Disorder: A Case Series.

INTRODUCTION: Monthly subcutaneous injectable buprenorphine (XR-Bup) is an option for treatment of opioid use disorder (OUD) that addresses some sublingual buprenorphine adherence barriers and is infrequently offered to hospitalized patients with OUD. METHODS: A retrospective case series was performed for patients receiving XR-Bup upon discharge from 1 academic medical center. Demographic information, diagnoses, follow-up, and documented factors informing the selection of XR-Bup were extracted from the electronic health record. RESULTS: In 1 year, 37 hospitalized patients with OUD received XR-Bup at discharge. The average age was 37.6 years, and patients were primarily Medicaid insured with an injection-related infection. The most common documented factors informing the selection of XR-Bup were as follows: previous sublingual buprenorphine adherence barriers, concurrent stimulant use disorder, and patient preference. Sixty-four percent of patients scheduled for follow-up attended appointments, and 55% received a second dose of XR-Bup. CONCLUSIONS: Subcutaneous injectable buprenorphine is an option for OUD treatment among hospitalized patients providing 30 or more days of buprenorphine coverage in the postdischarge period.

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report.

ABSTRACT: Persons with opioid use disorder (OUD) are receiving extended-release buprenorphine (ER-buprenorphine) for treatment of OUD. There are no clinical guidelines for management of patients with OUD on ER-buprenorphine experiencing acute or chronic pain. This case report describes 3 patient-involved, multidisciplinary approaches for pain management in various clinical scenarios, including a scheduled knee replacement, emergent surgery for an ischemic limb, and management of chronic pain from metastatic malignancy. These cases illustrate that adequate analgesia for patients who have received ER-buprenorphine is possible, and approaches can be individualized, with shared decision making between providers and patients addressing all barriers to optimize treatment outcomes. Options for acute pain management that can be considered include supplemental sublingual buprenorphine, nonopioid adjuncts, and short courses of full opioid agonists. Potential barriers that impact OUD and acute/chronic pain are provider bias, limited access to palliative care clinicians with addiction medicine training, and payor restrictions to adding sublingual buprenorphine for patients that are on ER-buprenorphine. Additional training for clinicians and other members of the health care team is recommended to improve patient-involved care of persons with OUD experiencing pain.

Willingness to utilize a mobile treatment unit in five counties at the epicenter of the US rural opioid epidemic.

INTRODUCTION: US federal policies are evolving to expand the provision of mobile treatment units (MTUs) offering medications for opioid use disorder (MOUD). Mobile MOUD services are critical for rural areas with poor geographic access to fixed-site treatment providers. This study explored willingness to utilize an MTU among a sample of people who use opioids in rural Eastern Kentucky counties at the epicenter of the US opioid epidemic. METHODS: The study analyzed Cross-sectional survey data from the Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) study covering five rural counties in the state. Logistic regression models investigated the association between willingness to utilize an MTU providing buprenorphine and naltrexone and potential correlates of willingness, identified using the Behavioral Model for Vulnerable Populations. RESULTS: The analytic sample comprised 174 people who used opioids within the past six months. Willingness to utilize an MTU was high; 76.5 % of participants endorsed being willing. Those who had recently received MOUD treatment, compared to those who had not received any form of treatment or recovery support services, had six-fold higher odds of willingness to use an MTU. However, odds of being willing to utilize an MTU were 73 % lower among those who were under community supervision (e.g., parole, probation) and 81 % lower among participants who experienced an overdose within the past six months. CONCLUSIONS: There was high acceptability of MTUs offering buprenorphine and naltrexone within this sample, highlighting the potential for MTUs to alleviate opioid-related harms in underserved rural areas. However, the finding that people who were recently under community supervision or had overdosed were significantly less willing to seek mobile MOUD treatment suggest barriers (e.g., stigma) to mobile MOUD at individual and systemic levels, which may prevent improving opioid-related outcomes in these rural communities given their high rates of criminal-legal involvement and overdose.

Get It in Writing: How to Make Medications for Opioid Use Disorder Available During Incarceration.

In a case example from the Kentucky HEALing Communities Study, extensive resources were deployed to address structural barriers and facilitate the provision of medication for opioid use disorder (OUD) in an urban county jail. However, implementation was unsuccessful, and this case example emphasizes the importance of including evidence-based medication for OUD (MOUD) treatment in the scope of work of jails' contracted medical providers. The privatization of correctional health care services allows local governments with opioid abatement funds to incorporate requirements into medical provider contracts to screen all people entering jails for OUD and to offer MOUD at intake, throughout incarceration, and upon release to everyone for whom it is clinically indicated. We provide sample contractual language that can be added to requests for medical provider proposals to help drive the private correctional health care market toward integrating MOUD treatment into their standard of care. This approach also could expedite efforts to scale up broad MOUD access across U.S. jails through sharing of workflows and best practices among the small group of national correctional health care companies contracted with jails in states with broad mandates, such as Massachusetts. Clinical Trial Registration: NCT04111939.

Advocacy for patients with opioid use disorder: A primer for physicians and other clinicians on the Americans with Disabilities Act.

Americans with opioid use disorder (OUD) have a disability that is protected under the Americans with Disabilities Act (ADA). Physicians may observe ADA violations when patients are forced to stop taking medications for opioid use disor-der (MOUD) as part of an entity's blanket policy that prohibits MOUD or when patients are denied medical treatment for various illnesses due to having an OUD diagnosis and/or receiving MOUD. Physicians and patients are likely unaware of how to identify potential ADA violations or what to do when they encounter one. This article will explain the ADA and how its protections are applicable to patients with OUD using several case examples. Physicians will learn to recognize possi-ble ADA violations and how to file a report with the Assistant United States Attorney. The article will outline how previous ADA settlements have addressed barriers to MOUD treatment access and highlight the need for more clinicians to serve as advocates to ensure all public entities and accommodations are in compliance with the ADA as it pertains to patients with OUD.

Contributions of a central registry to monitor methadone -treatment through the HEALing Communities Study.

OBJECTIVE: To describe the process of establishing a Methadone Central Registry (MCR) as part of the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) and to support recommendations with evidence of its functionality relative to Medicaid claims data for monitoring utilization of methadone, an evidence-based treatment for opioid use disorder. DESIGN AND PARTICIPANTS: The manuscript authors were active participants in establishing the MCR and include representation from state government, Opioid Treatment Programs (OTPs), and HCS university partners. Secondary data were obtained from Kentucky's (KY's) MCR and Medicaid claims from July 2020 through June 2021. The functionality of data obtained from the MCR, as measured by data completeness and timeliness, is compared with Medicaid claims, the current standard. MAIN OUTCOMES: Central registry and Medicaid data were each aggregated statewide and at the HCS-KY county level. Dual levels of analysis were selected to inform stakeholders at the study and state levels. Descriptive statistics were calculated for the number of patients in methadone treatment. RESULTS: Statewide, the MCR provided a daily record of all individuals receiving methadone through an OTP within 72 hours. In contrast, Medicaid claims processing lagged 9 months and captured 57-62 percent of patients in the MCR. CONCLUSIONS: Replacing a fax-based system, an MCR meets the converging need of providers, regulatory authorities, and researchers to monitor utilization, patient dual enrollment, and treatment outcomes. Implementation strategies included key stakeholder engagement, state partner leadership, training, and federal funding. Adoption of an MCR is recommended.

Telemedicine Buprenorphine Initiation and Retention in Opioid Use Disorder Treatment for Medicaid Enrollees.

Importance: Early COVID-19 mitigation strategies placed an additional burden on individuals seeking care for opioid use disorder (OUD). Telemedicine provided a way to initiate and maintain transmucosal buprenorphine treatment of OUD. Objective: To examine associations between transmucosal buprenorphine OUD treatment modality (telemedicine vs traditional) during the COVID-19 public health emergency and the health outcomes of treatment retention and opioid-related nonfatal overdose. Design, Setting, and Participants: This retrospective cohort study was conducted using Medicaid claims and enrollment data from November 1, 2019, to December 31, 2020, for individuals aged 18 to 64 years from Kentucky and Ohio. Data were collected and analyzed in June 2022, with data updated during revision in August 2023. Exposures: The primary exposure of interest was the modality of the transmucosal buprenorphine OUD treatment initiation. Relevant patient demographic and comorbidity characteristics were included in regression models. Main Outcomes and Measures: There were 2 main outcomes of interest: retention in treatment after initiation and opioid-related nonfatal overdose after initiation. For outcomes measured after initiation, a 90-day follow-up period was used. The main analysis used a new-user study design; transmucosal buprenorphine OUD treatment initiation was defined as initiation after more than a 60-day gap in buprenorphine treatment. In addition, uptake of telemedicine for buprenorphine was examined, overall and within patients initiating treatment, across quarters in 2020. Results: This study included 41 266 individuals in Kentucky (21 269 women [51.5%]; mean [SD] age, 37.9 [9.0] years) and 50 648 individuals in Ohio (26 425 women [52.2%]; mean [SD] age, 37.1 [9.3] years) who received buprenorphine in 2020, with 18 250 and 24 741 people initiating buprenorphine in Kentucky and Ohio, respectively. Telemedicine buprenorphine initiations increased sharply at the beginning of 2020. Compared with nontelemedicine initiation, telemedicine initiation was associated with better odds of 90-day retention with buprenorphine in both states (Kentucky: adjusted odds ratio, 1.13 [95% CI, 1.01-1.27]; Ohio: adjusted odds ratio, 1.19 [95% CI, 1.06-1.32]) in a regression analysis adjusting for patient demographic and comorbidity characteristics. Telemedicine initiation was not associated with opioid-related nonfatal overdose (Kentucky: adjusted odds ratio, 0.89 [95% CI, 0.56-1.40]; Ohio: adjusted odds ratio, 1.08 [95% CI, 0.83-1.41]). Conclusions and Relevance: In this cohort study of Medicaid enrollees receiving buprenorphine for OUD, telemedicine buprenorphine initiation was associated with retention in treatment early during the COVID-19 pandemic. These findings add to the literature demonstrating positive outcomes associated with the use of telemedicine for treatment of OUD.

Early emergency department experience with 7-day extended-release injectable buprenorphine for opioid use disorder.

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.

State alignment with federal regulations in 2022 to relax buprenorphine 30-patient waiver requirements.

Background: In 2021, the Department of Health and Human Services released guidelines allowing waiver-eligible providers seeking to treat up to 30 patients to be exempt from waiver training (WT) and the counseling and other ancillary services (CAS) attestation. This study evaluates if states and the District of Columbia had more restrictive policies preventing adoption of the 2021 federal guidelines. Methods: First, the Westlaw database was searched for buprenorphine regulations. Second, state medical, osteopathic, physician assistant, nursing boards, and single state agencies (SSA) were surveyed to assess for the WT and CAS requirements and if they were discussing the 2021 guidelines. Results were recorded and compared by state and waiver-eligible provider types. Results: The Westlaw search revealed seven states with regulations requiring the WT and ten states requiring CAS. Survey results showed ten state boards/SSAs required WT for at least one waiver-eligible practitioner type and eleven state boards/SSAs required CAS. In some states, the WT and CAS requirements only applied in special circumstances. Eleven states had discrepancies between the Westlaw and survey results among three waiver-eligible provider types. Conclusions: Despite the 2021 federal change intended to increase access to buprenorphine, several states had regulations and/or provider boards and SSAs that were not supportive. Now, the Mainstreaming Addiction Treatment (MAT) Act of 2022 eliminated the federal x-waiver requirement to prescribe buprenorphine. However, these states may continue to have barriers to treatment access despite the MAT Act. Strategies to engage states with these restrictive policies are needed to improve buprenorphine treatment capacity.

Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study.

INTRODUCTION: Pregnant individuals with substance use disorders face complex issues that may serve as barriers to treatment entry and retention. Several professional organizations have established recommendations on comprehensive, collaborative approaches to treatment to meet the needs of this population, but information on real-world application is lacking. Sites participating in the NIDA CTN0080 "Medication treatment for Opioid use disorder in expectant Mothers (MOMs)"-a randomized clinical trial of extended release compared to sublingual buprenorphine among pregnant and postpartum individuals (PPI)-were selected, in part, because they have a collaborative approach to treating PPI with opioid use disorder (OUD). However, organizational differences among sites and how they implement expert recommendations for collaborative care could impact study outcomes. METHODS: Prior to study launch at each of the 13 MOMs sites, investigators used the Pregnancy and Addiction Services Assessment (PAASA) to collect information about organizational factors. Input from a team of addiction, perinatal, and economic evaluation experts guided the development of the PAASA. Investigators programmed the PAASA into a web-based data system and summarized the resultant site data using descriptive statistics. RESULTS: Study sites represented four US census regions. Most sites were specialty obstetrics & gynecology (OB/GYN) programs providing OUD services (n = 9, 69.2 %), were affiliated with an academic institution (n = 11, 84.6 %), and prescribed buprenorphine in an ambulatory/outpatient setting (n = 11, 84.6 %); all sites offered access to naloxone. Sites reported that their population was primarily White, utilized public insurance, and faced numerous psychosocial barriers to treatment. Although all sites offered many services recommended by expert consensus groups, they varied in how they coordinated these services. CONCLUSIONS: By providing the organizational characteristics of sites participating in the MOMs study, this report assists in filling the current gap in knowledge regarding similar programs providing services to PPI with OUD. Collaborative care programs such as those participating in MOMs are uniquely positioned to participate in research to determine the most effective models of care and to determine how research can be integrated into those clinical care settings.

Treating Opioid Use Disorder in Patients Who Are Incarcerated: Quandaries of a Hospitalist.

This Viewpoint discusses the importance of ensuring that life-saving medication for opioid use disorder is available to hospitalized persons who are incarcerated.

Facilitating factors and barriers for use of medications to treat opioid use disorder (MOUD) among justice-involved individuals in rural Appalachia.

The purpose of this qualitative study is to assess facilitating factors and barriers for medications to treat opioid use disorder (MOUD) initiation among justice-involved individuals in one rural Appalachian community, as well as how those factors may differ across the three types of Food and Drug Administration (FDA) approved medications. Qualitative interviews were conducted with rural justice-involved individuals (N = 10) with a history of opioid use in the target community. Overall, participants demonstrated knowledge of the different types of MOUD and their pharmacological properties, but limited overall health literacy around opioid use disorder and MOUD treatment. Treatment access was hampered by transportation, time burdens, and costs. Findings call for research into improving health literacy education, training, and resources to decrease stigma and increase access to MOUD, particularly in light of the ongoing opioid crisis. State policies also need to increase access to all FDA medications among justice-involved individuals, as well as supporting a care continuum from facility entry, release, and community re-entry.