The Impact of High-Potency Synthetic Opioids on Pharmacotherapies for Opioid Use Disorder: A Scoping Review.

BACKGROUND: The clinical implications of high potency synthetic opioids (HPSO) on medications for opioid use disorder (MOUDs) are not well understood. Although pharmacological interactions are plausible, the clinical significance of such interaction has not been systematically elucidated. This scoping review investigates the relationship between HPSO exposure and various MOUD treatment outcomes. METHODS: We followed PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews) for scoping reviews with extensive a priori search strategy of databases: MEDLINE, EMBASE, PsycINFO, Web of Science, CINAHL, and Cochrane. RESULTS: From 9149 studies, 34 fulfilled the inclusion criteria. Synthesized data reveal several critical insights: First, there is a variable but high occurrence (38%-80%) of HPSO usage among individuals with MOUDs. Second, MOUDs are linked to a decreased risk of overdoses and deaths associated with HPSO. Third, HPSO consumption is correlated with the risk of precipitated withdrawal when starting buprenorphine. Fourth, low-dose buprenorphine is being recognized as one method to avoid moderate withdrawal symptoms prior to treatment. Lastly, significant gaps exist in human experimental data concerning the effects of HPSO on key factors critical for treating OUD-craving, withdrawal symptoms, and pain. CONCLUSIONS: Current evidence supports MOUD safety and effectiveness in reducing nonmedical opioid use. Further research is needed to explore HPSO's influence on the acute factors preceding nonmedical opioid use, such as cravings, withdrawal symptoms, and pain. This research could inform the optimization of MOUD dosing strategies. Achieving consensus and harmonizing data across clinical and research protocols could diminish variability, enhancing our understanding of HPSOs effect on MOUD treatment outcomes.

Variation in Opioid Agonist Dosing in Clinical Trials by Race and Ethnicity.

Importance: Racial and ethnic disparities in access to treatment and quality of treatment for opioid use disorder (OUD) have been identified in usual care settings. In contrast, disparities in treatment quality within clinical trials are relatively unexamined. Objective: To estimate racial and ethnic differences in the dose of opioid agonist treatment for OUD in the first 4 weeks of treatment in clinical trials. Design, Setting, and Participants: This cohort study performed analysis of the methadone and buprenorphine treatment arms of 3 trials conducted by the National Institute on Drug Abuse Clinical Trials Network between May 2006, and January 31, 2017, at multiple Clinical Trials Network sites across the US. Trial participants who were randomized to and initiated buprenorphine or methadone treatment and who identified as Hispanic, non-Hispanic Black, or non-Hispanic White were included in the present study. Data were analyzed from November 1, 2023, to August 5, 2024. Exposure: Combined race and ethnicity as self-classified by the patient at trial enrollment. Main Outcomes and Measures: The maximum daily dose of buprenorphine or methadone received in each week for the first 4 weeks of treatment. The mean dose and the percentage of patients receiving a higher dose (buprenorphine ≥16 mg and methadone ≥60 mg) were compared across race and ethnicity groups. Results: A total of 1748 patients (1263 who initiated buprenorphine and 485 who initiated methadone treatment) were included in the analysis (1168 [66.8%] male; median age, 33 [IQR, 26-45] years). Of these, 138 patients (7.9%) identified as Black, 273 (15.6%) as Hispanic, and 1337 (76.5%) as White. In week 4, Black patients received buprenorphine doses 2.5 (95% CI -4.6 to -0.5) mg lower and methadone doses 16.7 (95% CI, -30.7 to -2.7) mg lower compared with White patients, after standardizing by age and sex. In week 4, the percentage of patients receiving a higher dose of medication (buprenorphine ≥16 mg; methadone ≥60 mg) was 16.9 (95% CI, -31.9 to -1.9) points lower for Black patients compared with White patients. Hispanic and White patients received similar buprenorphine doses; Hispanic patients received lower methadone doses than White patients. Conclusions and Relevance: In this cohort study of data from 3 clinical trials, White patients generally received higher doses of medication than Black patients. Future research is needed to understand the mechanisms of and interventions to reduce disparities in OUD treatment quality and how such disparities impact generalizability of trial results.

The Odyssey of HOMER: Comparative Effectiveness Research on Medication for Opioid Use Disorder During the COVID-19 Pandemic.

The usual challenges of conducting primary care research, including randomized trials, have been exacerbated, and new ones identified, during the COVID-19 pandemic. HOMER (Home versus Office for Medication Enhanced Recovery; subsequently, Comparing Home, Office, and Telehealth Induction for Medication Enhanced Recovery) is a pragmatic, comparative-effectiveness research trial that aims to answer a key question from patients and clinicians: What is the best setting in which to start treatment with buprenorphine for opioid use disorder for this patient at this time? In this article, we describe the difficult journey to find the answer. The HOMER study began as a randomized trial comparing treatment outcomes in patients starting treatment with buprenorphine via induction at home (unobserved) vs in the office (observed, synchronous). The study aimed to enroll 1,000 participants from 100 diverse primary care practices associated with the State Networks of Colorado Ambulatory Practices and Partners and the American Academy of Family Physicians National Research Network. The research team faced unexpected challenges related to the COVID-19 pandemic and dramatic changes in the opioid epidemic. These challenges required changes to the study design, protocol, recruitment intensity, and funding conversations, as well as patience. As this is a participatory research study, we sought, documented, and responded to practice and patient requests for adaptations. Changes included adding a third study arm using telehealth induction (observed via telephone or video, synchronous) and switching to a comprehensive cohort design to answer meaningful patient-centered research questions. Using a narrative approach based on the Greek myth of Homer, we describe here the challenges and adaptations that have provided the opportunity for HOMER to thrive and find the way home. These clinical trial strategies may apply to other studies faced with similar cultural and extreme circumstances.

Switch from methadone to buprenorphine with microinduction in outpatient setting. / Poliklinisk skifte fra metadon til buprenorfin med mikroinduksjon.

Background: Switching from methadone to buprenorphine in patients receiving opioid maintenance therapy often requires inpatient care with a gradual tapering of methadone and an opioid-free day with challenging withdrawal symptoms. This case report describes and discusses a gentle outpatient approach without the opioid-free day. Case presentation: A patient with a 15-year history of opioid maintenance therapy reduced his methadone dose from 80 mg to 50 mg due to concurrent use of other sedative substances and a significant risk of overdose. A week-long switch to buprenorphine 16 mg subcutaneous depot formulation was then undertaken using a microinduction approach in the outpatient setting. Interpretation: In line with earlier reports on microinduction, the switch from methadone to buprenorphine was carried out with no opioid withdrawal symptoms or complications. Microinduction offers a smooth and more patient-friendly approach to switching from full opioid agonists to partial agonists. Randomised controlled trials are, however, needed for a systematic evaluation of this method.

Outpatient Cross-Titration to Buprenorphine for Chronic Pain.

BACKGROUND: Various protocols for micro-induction of buprenorphine in patients with opioid use disorder have been published. There is a paucity of literature similarly describing micro- induction in patients converting from full agonist opioids to buprenorphine for chronic pain. As the prescription opioid epidemic continues to be problematic and more patients are being converted to buprenorphine, we are working to provide more guidance on goal dosages of buprenorphine and how to safely cross-titrate to that goal. PURPOSE/HYPOTHESIS: As the prescription opioid epidemic continues to be problematic and more patients are being converted to buprenorphine, we are working to provide more guidance on goal dosages of buprenorphine and how to safely cross-titrate to that goal. Procedures/data/observations: Our cross-titration protocol resulted in roughly half (15/31) patients successfully converting to and continuing with buprenorphine at 4 weeks, with an average duration of induction of 29 days. Average end titration dose for patients on buprenorphine/naloxone SL films was 7.9 ± 5.7 mg/day. Patients previously taking >120 mg MEDD stabilized on 8-16 mg/day. CONCLUSIONS/APPLICATIONS: Clinical responses were widely variable, and many required slower taper and higher end titration buprenorphine dose than anticipated. Future work is focused on determining which factors contribute to the variation and whether adjustment to the protocol is warranted.

Partial Agonist, Full Barrier: A Case-Based Discussion on Challenges with Buprenorphine in Chronic Pain Management.

BACKGROUND: More patients are on chronic opioids, as patients who were initially started on full agonist opioids for cancer-related pain are living longer. Despite doing well from the cancer stand- point, some patients have difficulty tapering off their opioids because they have been taking them for years. Given the potential complications of chronic full agonist opioids, it is important to manage these patients in a safer way. However, there are various challenges including lack of education for patients and healthcare professionals and lack of product availability. Many healthcare providers do not have much formal training on initiating, maintaining, and tapering the various buprenorphine products. These providers may not be able to effectively educate patients given the lack of education. Also, patients research these products on their own and are hesitant to try them because of misinformation. Even if patients are informed thoroughly about buprenorphine, there are barriers to obtaining them including insurance denial and lack of product availability at pharmacies. Given the above challenges, easily accessible best practices as well as avenues for healthcare professionals to educate and guide each other are needed. PURPOSE/HYPOTHESIS: Given the potential complications of chronic full agonist opioids, it is important to manage these patients in a safer way. However, there are various challenges including lack of education for patients and healthcare professionals and lack of product availability. CONCLUSIONS/APPLICATIONS: Given the above challenges, easily accessible best practices as well as avenues for healthcare professionals to educate and guide each other are needed.

Emerging Trends in Perioperative Buprenorphine Management.

BACKGROUND: Historically, there has been limited evidence and no clear consensus suggesting best practices for perioperative buprenorphine management (PBM). Previously published PBM strategies included a wide variation in dosing, complexity, and clinical decision making points. Importantly, there are limited published algorithms reporting corresponding patient outcomes data. PURPOSE/HYPOTHESIS: To review the literature for newly published perioperative PBM strategies, with the aims of identifying emerging trends and assessing patient outcomes data. Procedures/data/observations: Literature review of manuscripts published from 2020 to current containing PBM strategies. CONCLUSIONS/APPLICATIONS: Pending completion of analysis, the authors will present findings of emerging trends and patient outcomes data in PBM.

The "Micro"cosm: Magnifying the Nuance of Low Dose Buprenorphine Inductions.

BACKGROUND: Now that the X-wavier is a thing of the past, patients with Opioid Use Disorder (OUD) who previously lacked access to buprenorphine may have access to lower barrier care and may be looking to make the transition from either methadone or illicit fentanyl to buprenorphine. This can be quite challenging and both fentanyl and methadone are hihghly potent drugs and can result in a difficult transtition to buprenorphine. PURPOSE/HYPOTHESIS: A transition from high potency opioids to buprenorphine is challenging and can cause discomfort or withdrawal in patients. Procedures/data/observations: Patients tend to have a difficult time when undergoing a transition from significant fentanyl use (> 1 bundle/day) or high dose methadone to buprenorphine. Over the last year, we've supported this transition for our hospitalized patients and have learned some tips and tricks to ease the transitions. Through our work we've come up with a strategy to transition patients that includes utilizing full mu agonists while initiating a low dose buprenorphine induction. We have developed an informal protocol for this transition that takes advantage of the flexibility of low dose buprenorphine induction strategies and includes the use of non-opioid adjuvant medications to control symptoms of discomfort and withdrawal. CONCLUSIONS/APPLICATIONS: A transition from the use of significant fentanyl or high dose methadone to buprenorphine is possible and can take place over a matter of a few days. Such a transition requires careful attention to patient symptoms, availability of as needed short acting opioids, and the judicious use of non-opioid adjuvants.

Buprenorphine-Precipitated Withdrawal Among Hospitalized Patients Using Fentanyl.

Importance: Buprenorphine treatment of opioid use disorder (OUD) is safe and effective, but opioid withdrawal during treatment initiation is associated with poor retention in care. As fentanyl has replaced heroin in the drug supply, case reports and surveys have indicated increased concern for buprenorphine-precipitated withdrawal (PW); however, some observational studies have found a low incidence of PW. Objective: To estimate buprenorphine PW incidence and assess factors associated with PW among emergency department (ED) or hospitalized patients. Design, Setting, and Participants: This retrospective cohort study at 3 academic hospitals in Philadelphia, Pennsylvania, included adults with OUD who underwent traditional or high-dose buprenorphine initiation between January 1, 2020, and December 31, 2021. Exclusion criteria included low-dose buprenorphine initiation and missing documentation of opioid withdrawal severity within 4 hours of receiving buprenorphine. Exposure: Buprenorphine initiation with an initial dose of at least 2 mg of sublingual buprenorphine after a Clinical Opiate Withdrawal Scale (COWS) score of 8 or higher. Additional exposures included 4 predefined factors potentially associated with PW: severity of opioid withdrawal before buprenorphine (COWS score of 8-12 vs ≥13), initial buprenorphine dose (2 vs 4 or ≥8 mg), body mass index (BMI) (<25 vs 25 to <30 or ≥30; calculated as weight in kilograms divided by height in meters squared), and urine fentanyl concentration (0 to <20 vs 20 to <200 or ≥200 ng/mL). Main Outcome and Measures: The main outcome was PW incidence, defined as a 5-point or greater increase in COWS score from immediately before to within 4 hours after buprenorphine initiation. Logistic regression was used to estimate the odds of PW associated with the 4 aforementioned predefined factors. Results: The cohort included 226 patients (150 [66.4%] male; mean [SD] age, 38.6 [10.8] years). Overall, 26 patients (11.5%) met criteria for PW. Among patients with PW, median change in COWS score was 9 points (IQR, 6-13 points). Of 123 patients with confirmed fentanyl use, 20 (16.3%) had PW. In unadjusted and adjusted models, BMI of 30 or greater compared with less than 25 (adjusted odds ratio [AOR], 5.12; 95% CI, 1.31-19.92) and urine fentanyl concentration of 200 ng/mL or greater compared with less than 20 ng/mL (AOR, 8.37; 95% CI, 1.60-43.89) were associated with PW. Conclusions and Relevance: In this retrospective cohort study, 11.5% of patients developed PW after buprenorphine initiation in ED or hospital settings. Future studies should confirm the rate of PW and assess whether bioaccumulated fentanyl is a risk factor for PW.

Association of Daily Doses of Buprenorphine With Urgent Health Care Utilization.

Importance: Higher buprenorphine doses may benefit the increasing number of individuals using fentanyl and other synthetic opioids, but there is little empirical evidence on the efficacy of such higher doses. Objective: To examine the association between higher buprenorphine doses (above 16 mg and 24 mg) and subsequent emergency department (ED) or inpatient service use among patients diagnosed with opioid use disorder. Design, Setting, and Participants: This cross-sectional study was a retrospective analysis of health data from Optum's deidentified Clinformatics Data Mart Database from 2016 to 2021 for commercially insured individuals aged 18 years or older diagnosed with opioid use disorder (OUD). Eligible participants initiated buprenorphine after at least 90 days of enrollment and were dispensed at least a 14-day supply of buprenorphine. Data were analyzed from September 2023 through February 2024. Exposures: Maximum buprenorphine dose received by a patient for 14 or more days: more than 24 mg, more than 16 mg to 24 mg, more than 8 mg to 16 mg, or 1 mg to 8 mg. Main Outcomes and Measures: Days from initiation of the maximum buprenorphine dose to an ED or inpatient visit for a behavioral health diagnosis, controlling for patient demographics, comorbid conditions, time to reaching maximum dose, buprenorphine discontinuation, and pre-buprenorphine health care utilization. Results: A total of 35 451 individuals with an OUD diagnosis who began buprenorphine treatment were identified (mean [SD] age, 46.2 [15.1] years; 20 983 male [59.2%]; 3326 Black [9.4%], 2411 Hispanic [6.8%], 26 712 White [75.3%]). The most common dose was more than 8 mg to 16 mg daily (14 802 patients [42.9%]), with 9669 patients (27.3%) in the 1 mg to 8 mg tier, 10 329 patients (29.1%) in the 8 mg to 16 mg tier, and 651 patients (1.8%) in the tier receiving more than 24 mg. Among all patients receiving buprenorphine, 12.5% experienced an ED or inpatient visit. Survival analysis shows patients receiving doses more than 24 mg and between 16 mg to 24 mg had longer times to ED or inpatient use than patients receiving from 8 mg to 16 mg (time ratio [TR], 1.11; 95% CI, 1.02 to 1.20) and more than 24 mg (TR, 1.37; 95% CI, 1.04 to 1.81). Findings for doses above 16 mg daily were consistent for observation windows as short as 365 days (more than 24 mg: TR, 1.48; 95% CI, 1.01-2.18; more than 16 mg to 24 mg: TR, 1.19; 95% CI, 1.06-1.32). Conclusions and Relevance: These findings contribute to the sparse empirical research regarding potential benefits of higher-dose buprenorphine treatment of individuals with OUD. Clinicians should be aware of the potential effects of higher buprenorphine doses on health care utilization while policymakers work to ensure equitable access to individuals who could potentially benefit from higher doses.

Clinician Willingness to Prescribe Medications for Opioid Use Disorder to Adolescents in Indiana.

Importance: Prescribing medications for opioid use disorders (MOUD), including buprenorphine, naltrexone, and methadone, to adolescents remains an underused evidence-based strategy for reducing harms associated with opioid use. Objective: To identify potential associations between clinician- and community-level characteristics regarding clinicians' self-reported willingness to prescribe MOUD to adolescents. Design, Setting, and Participants: This cross-sectional study included a phone survey of Indiana clinicians and spatial analysis of community-level characteristics. Clinicians were eligible for inclusion in analyses if actively providing health care and listed on the Buprenorphine Practitioner Locator website, a publicly available national registry of clinicians possessing a waiver to legally prescribe buprenorphine (ie, waivered clinicians). Exposures: Community-level characteristics, including total population, rurality or urbanicity, percentage with incomes below the federal poverty line, and racial or ethnic makeup. Main Outcomes and Measures: Clinicians were asked about their willingness to prescribe MOUD to adolescents younger than 18 years if clinically indicated. Responses were recorded as no, yes, or yes with conditions. Results: Among the 871 clinicians listed on the website as of July 2022, 832 were eligible for inclusion and contacted by phone. Among waivered clinicians, 759 (91.2%) reported being unwilling to prescribe MOUD to adolescents, 73 clinicians (8.8%) reported willingness to prescribe MOUD to adolescents, and only 24 (2.9%) would do so without conditions. A multivariable logistic regression model including spatially lagged community-level variables showed that, among areas with waivered clinicians, clinicians practicing in more populated areas were significantly less likely to prescribe to adolescents (ß = 0.65; 95% CI, 0.49-0.87; P = .003). Similarly, those in more rural areas were significantly more likely to prescribe to adolescents (ß = 1.27; 95% CI, 1.02-1.58; P = .03). Variation in clinician willingness to prescribe was not explained by other community-level characteristics. Among all waivered clinicians, advanced practice clinicians were less likely than physicians to report willingness to prescribe (ß = 0.58; 95% CI, 0.35-0.97; P = .04), as were physicians without any specialty training relevant to MOUD prescribing when compared with family medicine clinicians (ß = 0.40; 95% CI, 0.18-0.89; P = .03). A small subgroup of waivered clinicians had training in pediatrics (13 clinicians [1.6%]), and none were willing to prescribe MOUD to adolescents. Conclusions and Relevance: From this cross-sectional study, it appears that Indiana adolescents continued to face gaps in access to MOUD treatment, despite its well-established efficacy. Programs that support primary care practitioners, including family medicine clinicians and pediatricians, in safe and appropriate use of MOUD in adolescents may bridge these gaps.

Knowledge of medications for opioid use disorder and associated stigma among primary care professionals.

BACKGROUND: Medications for opioid use disorder (MOUD) are the gold standard. However, significant barriers limit their use in the primary care setting, including limited knowledge of the medications and stigmatizing attitudes. In this study, we assess knowledge levels among primary care-aligned professionals (PCPs) currently in practice, and whether knowledge of MOUD is associated with stigma and treatment attitudes. PARTICIPANTS AND METHODS: Using rosters from the state of Ohio licensing boards, we surveyed 403 physicians, nurse practitioners, and physician associates in 2022, on the mechanism of different MOUD, as well as stigma and treatment attitudes. To assess MOUD knowledge, we employed descriptive and bivariate statistics. We fit four linear regression models, which controlled for empathy towards patients with OUD and provider demographics to assess the relationship between MOUD knowledge and four endpoints: stigma, perceived controllability of opioid use, perceived vulnerability to opioid use disorder, and support for abstinence-only treatment. RESULTS: 43% of participants correctly identified the mechanism of all 3 medications whereas 13% of participants did not identify the mechanism of any MOUD correctly. MOUD knowledge was higher among physicians as compared to nurse practitioners and physician associates. Lower MOUD knowledge was associated with more negative attitudes towards patients with OUD and MOUD treatment. CONCLUSION: Expanding access to MOUD treatment requires a trained and willing health-care professional (HCP) workforce. Our findings highlight considerable variation in clinician knowledge of MOUD and suggest that knowledge levels are also related to negative attitudes towards patients with OUD and MOUD. Training interventions that increase knowledge, as well as focus on stigma reduction, are critical for reducing the longstanding treatment gap for opioid use disorder.

An Assertive Community Intervention to Engage Youth with Opioid Use Disorder and Their Families.

Medications for opioid use disorder (MOUD) are the most effective treatment for OUD. Many patients struggle with adherence, but young adults face unique developmental barriers and experience higher relapse rates. The Youth Opioid Recovery Support (YORS) intervention is a developmentally informed behavioral approach to increase medication adherence through assertive outreach, family involvement, low-barrier access to extended-release MOUD, and contingency management. Early studies have shown promising results, and a randomized controlled trial is underway. Here we describe the implementation of YORS using case examples, offer guidance on adapting YORS to real-world clinical settings, and explore future directions for research and practice.

Implementation of a rural emergency department-initiated buprenorphine program in the mountain west: a study protocol.

BACKGROUND: Opioid related overdose morbidity and mortality continue to significantly impact rural communities. Nationwide, emergency departments (EDs) have seen an increase in opioid use disorder (OUD)-related visits compared to other substance use disorders (SUD). ED-initiated buprenorphine is associated with increased treatment engagement at 30 days. However, few studies assess rural ED-initiated buprenorphine implementation, which has unique implementation barriers. This protocol outlines the rationale and methods of a rural ED-initiated buprenorphine program implementation study. METHODS: This is a two-year longitudinal implementation design with repeated qualitative and quantitative measures of an ED-initiated buprenorphine program in the rural Mountain West. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outlines intervention assessments. The primary outcome is implementation measured by ED-initiated buprenorphine protocol core components. Reach, adoption, and maintenance are secondary outcomes. External facilitators from an academic institution with addiction medicine and prior program implementation expertise partnered with community hospital internal facilitators to form an implementation team. External facilitators provide ongoing support, recommendations, education, and academic detailing. The implementation team designed and implemented the rural ED-initiated buprenorphine program. The program includes OUD screening, low-threshold buprenorphine initiation, naloxone distribution and administration training, and patient navigator incorporation to provide warm hand off referrals for outpatient OUD management. To address rural based implementation barriers, we organized implementation strategies based on Expert Recommendations for Implementing Change (ERIC). Implementation strategies include ED workflow redesign, local needs assessments, ED staff education, hospital leadership and clinical champion involvement, as well as patient and community resources engagement. DISCUSSION: Most ED-initiated buprenorphine implementation studies have been conducted in urban settings, with few involving rural areas and none have been done in the rural Mountain West. Rural EDs face unique barriers, but tailored implementation strategies with external facilitation support may help address these. This protocol could help identify effective rural ED-initiated buprenorphine implementation strategies to integrate more accessible OUD treatment within rural communities to prevent further morbidity and mortality. TRIAL REGISTRATION: ClinicalTrials.gov National Clinical Trials, NCT06087991. Registered 11 October 2023 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06087991 .

Perceptions of extended-release buprenorphine among people who received medication for opioid use disorder in jail: a qualitative study.

BACKGROUND: Incarceration provides an opportunity for health interventions, including opioid use disorder (OUD) treatment and prevention of opioid-related overdoses post-release. All FDA-approved forms of medication for OUD (MOUD) treatment were mandated in several Massachusetts jails in 2019, with some jails offering extended-release buprenorphine (XR-Bup). Little is known about patient perspectives on and experiences with XR-Bup in carceral settings. METHODS: We conducted semi-structured interviews in 2022 with community-dwelling people who received MOUD during a recent incarceration in a Massachusetts jail. We asked participants about their experiences with and perspectives on XR-Bup while in jail. Qualitative data were double-coded deductively and reviewed inductively to identify emergent themes, which were structured using the Theoretical Framework of Acceptability (TFA). RESULTS: Participants (n = 38) had a mean age of 41.5 years, were 86% male, 84% White, 24% Hispanic, and 95% continued to receive MOUD at the time of their interview, including 11% receiving XR-Bup. Participants who viewed XR-Bup favorably appreciated avoiding the taste of sublingual buprenorphine; avoiding procedural difficulties and indignities associated with daily dosing in carceral settings (e.g., mouth checks, stigmatizing treatment from correctional staff); avoiding daily reminders of their addiction; experiencing less withdrawal; having extra time for other activities, such as work; and reduction of diversion of MOUD within the jail setting. Participants who viewed XR-Bup less favorably preferred to maintain their daily dosing routine; liked daily time out of their housing unit; wanted to know what was "going into my body everyday"; and feared needles and adverse events. Participants also reported that jail clinicians used XR-Bup for patients who were previously caught diverting sublingual buprenorphine, suggesting limited patient participation in decision-making around XR-Bup initiation in some jails. CONCLUSION: People who received MOUD in Massachusetts jails had both favorable and unfavorable views and experiences with XR-Bup. Understanding these preferences can inform protocols in jails that are considering implementation of XR-Bup treatment.

Lost in transition: A protocol for a retrospective, longitudinal cohort study for addressing challenges in opioid treatment for transition-age adults.

BACKGROUND: In the United States, there has been a concerning rise in the prevalence of opioid use disorders (OUD) among transition-age (TA) adults, 18 to 25-years old, with a disproportionate impact on individuals and families covered by Medicaid. Of equal concern, the treatment system continues to underperform for many young people, emphasizing the need to address the treatment challenges faced by this vulnerable population at a pivotal juncture in their life course. Pharmacotherapy is the most effective treatment for OUD, yet notably, observational studies reveal gaps in the receipt of and retention in medications for opioid use disorder (MOUD), resulting in poor outcomes for many TA adults in treatment. Few current studies on OUD treatment quality explicitly consider the influence of individual, organizational, and contextual factors, especially for young people whose social roles and institutional ties remain in flux. METHODS: We introduce a retrospective, longitudinal cohort design to study treatment quality practices and outcomes among approximately 65,000 TA adults entering treatment for OUD between 2012 and 2025 in New York. We propose to combine data from multiple sources, including Medicaid claims and encounter data and a state registry of substance use disorder (SUD) treatment episodes, to examine three aspects of OUD treatment quality: 1) MOUD use, including MOUD option (e.g., buprenorphine, methadone, or extended-release [XR] naltrexone); 2) adherence to pharmacotherapy and retention in treatment; and 3) adverse events (e.g., overdoses). Using rigorous analytical methods, we will provide insights into how variation in treatment practices and outcomes are structured more broadly by multilevel processes related to communities, treatment programs, and characteristics of the patient, as well as their complex interplay. DISCUSSION: Our findings will inform clinical decision making by patients and providers as well as public health responses to the rising number of young adults seeking treatment for OUD amidst the opioid and polysubstance overdose crisis in the U.S.

Comparative Safety of In Utero Exposure to Buprenorphine Combined With Naloxone vs Buprenorphine Alone.

Importance: Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product. Objective: To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone. Design, Settings, and Participants: Population-based cohort study using health care utilization data from Medicaid-insured beneficiaries in the US from 2000 to 2018. The cohort was restricted to pregnant individuals linked to their liveborn infants, with maternal Medicaid enrollment from 3 months before pregnancy to 1 month after delivery and infant enrollment for the first 3 months after birth, unless they died sooner. Exposure: Use of buprenorphine with naloxone vs buprenorphine alone during the first trimester based on outpatient dispensings. Main Outcomes and Measures: Outcomes included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity. Confounder-adjusted risk ratios were calculated using propensity score overlap weights. Results: This study identified 3369 pregnant individuals exposed to buprenorphine with naloxone during the first trimester (mean [SD] age, 28.8 [4.6] years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean [SD] age, 28.3 [4.5] years). When comparing buprenorphine combined with naloxone with buprenorphine alone, a lower risk for neonatal abstinence syndrome (absolute risk, 37.4% vs 55.8%; weighted relative risk, 0.77 [95% CI, 0.70-0.84]) and a modestly lower risk for neonatal intensive care unit admission (absolute risk, 30.6% vs 34.9%; weighted relative risk, 0.91 [95% CI, 0.85-0.98]) and small for gestational age (absolute risk, 10.0% vs 12.4%; weighted relative risk, 0.86 [95% CI, 0.75-0.98]) was observed. For maternal morbidity, the comparative rates were 2.6% vs 2.9%, respectively, and the weighted relative risk was 0.90 (95% CI, 0.68-1.19). No differences were observed with respect to major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery. Results were consistent across sensitivity analyses. Conclusions and Relevance: There were similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for the treatment of opioid use disorder in pregnancy, affirming flexibility in collaborative treatment decision-making.

Buprenorphine Induction in Trauma Patients With Opioid Use Disorder - A Single Center Experience?

INTRODUCTION: Buprenorphine is a Food and Drug Administration-approved therapy for opioid use disorder, with proven efficacy in treatment retention and reduction in opioid use and mortality. Low-dose buprenorphine initiation or microinduction is a novel means of initiation that may allow for an easier transition in patients. Trauma patients have high rates of opioid use disorder and patient directed discharges (PDD). We hypothesized that patients initiated on a buprenorphine microinduction program would have increased protocol completion and fewer PDD compared with patients initiated historically on a traditional induction. METHODS: Our retrospective cohort study compared buprenorphine microinduction and traditional induction in trauma patients at an urban level one trauma center between December 2020 and June 2022. Patients aged 18-89 y with traumatic injuries who received buprenorphine were included. Our primary outcome was in-hospital protocol completion, defined as reaching 16 mg of buprenorphine within 24 h or a documented stable dose. Statistical analysis was performed using chi-square for categorical variables and two sample t-tests for continuous variables. RESULTS: Ninety-eight patients were included, with 46 initiating with microinduction and 52 initiating with traditional induction. There was no difference in protocol completion, (P = 0.29) and 83% of subjects who started an induction protocol completed it. Those who completed a protocol were more likely to be discharged home (P = 0.0002), had less PDD (P = 0.001), and had an increased likelihood of attending outpatient addiction clinic follow-up (P = 0.038). CONCLUSIONS: Regardless of the protocol type, buprenorphine induction can be implemented in trauma patients with high protocol completion rates. In our population, those who complete a protocol had a higher likelihood of discharge home and postdischarge follow-up in addiction medicine clinic.