Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial.

BACKGROUND: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial. METHODS: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts. RESULTS: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care. CONCLUSIONS: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.

Incarceration history and opioid use among adults living with HIV and chronic pain: a secondary analysis of a prospective cohort study.

BACKGROUND: Adults living with HIV have disproportionately high chronic pain, prescription opioid use, history of substance use, and incarceration. While incarceration can have long-lasting health impacts, prior studies have not examined whether distant (>1 year prior) incarceration is associated with opioid use for chronic pain, or with opioid misuse or opioid use disorder among people living with HIV and chronic pain. METHODS: We conducted a secondary analysis of a prospective cohort study of adults living with HIV and chronic pain. The independent variables were any distant incarceration and drug-related distant incarceration (both dichotomous). Dependent variables were current long-term opioid therapy, current opioid misuse, and current opioid use disorder. A series of multivariate logistic regression models were conducted, adjusting for covariates. RESULTS: In a cohort of 148 participants, neither distant incarceration nor drug-related incarceration history were associated with current long-term opioid therapy. Distant incarceration was associated with current opioid misuse (AOR 3.28; 95% CI: 1.41-7.61) and current opioid use disorder (AOR 4.40; 95% CI: 1.54-12.56). Drug-related incarceration history was also associated with current opioid misuse (AOR 4.31; 95% CI: 1.53-12.17) and current opioid use disorder (AOR 7.28; 95% CI: 2.06-25.71). CONCLUSIONS: The positive associations of distant incarceration with current opioid misuse and current opioid use disorder could indicate a persistent relationship between incarceration and substance use in people living with HIV and chronic pain. Additional research on opioid use among formerly incarcerated individuals in chronic pain treatment is needed.

Methadone dosing at New York State opioid treatment programs following initial revisions to federal regulations.

INTRODUCTION: In March 2020, a temporary federal regulatory exemption for opioid treatment programs (OTPs) was issued, allowing for a greater number of take-home methadone doses than was previously permitted. In the same month, to address financial sustainability, New York State (NYS) Medicaid also transitioned to a bundle reimbursement methodology for OTPs. We examined methadone dosing schedules in NYS before and after these regulatory and financing changes. METHODS: We conducted a retrospective cohort study using NYS OTP patient data from two sources: the client data system for a baseline period (February 2020) and survey data collected after regulatory and financing changes (May 2020 to August 2021, 64 weekly surveys). We compared methadone dosing schedules over time using chi-square tests and Poisson regression. RESULT: At baseline, data were available for 78% (n=77/99) of OTPs including 90.9% (n=26,225/28,839) of their enrolled patients. During the survey period, 99 OTPs completed 93.1% (n=5901/6336) of weekly surveys, with a mean statewide weekly patient census of 38,904 (SD=1214.5). Between February and May 2020, daily dosing significantly decreased from 55.4% to 16.3% of patients (-39.1 percentage points [95%CI: -39.8 to -38.4]), although it significantly increased subsequently (3.33%/4-weeks [95%CI: 3.28, 3.39]). In addition, weekly-to-monthly dosing significantly increased from 26.9% to 54.5% of patients (27.6 percentage points [95%CI: 26.9, 28.4]), although it significantly decreased subsequently (-1.19%/4-weeks [95%CI: -1.23, -1.15]). DISCUSSION: Despite large initial changes, we found a trend toward gradual return to more restrictive dosing schedules. OTPs need further support in leveraging new opportunities to improve methadone treatment and outcomes.

Mitigation through on-site testing & education among formerly incarcerated individuals against Covid-19 - The MOSAIC study: Design and rationale.

BACKGROUND: Many of the largest COVID-19 outbreaks in the United States have occurred at carceral facilities. Criminal legal system (CLS)-involved individuals typically face structural barriers accessing medical care post-release. Improving COVID-19 testing and education for CLS-involved individuals could improve health outcomes for this vulnerable population and the communities to which they return. Community-based organizations (CBO) and community health workers (CHWs) fill care gaps by connecting CLS-involved individuals with essential re-entry services. The MOSAIC study will: 1) test an onsite CHW-led SARS-CoV-2 testing and education intervention in a reentry CBO and 2) model the cost-effectiveness of this intervention compared to standard care. METHODS: We will recruit 250 CLS-involved individuals who have left incarceration in the prior 90 days. Participants will be randomized to receive onsite Point-of-Care testing and education (O-PoC) or Standard of Care (SoC). Over one year, participants will complete quarterly questionnaires and biweekly short surveys through a mobile application, and be tested for SARS-CoV-2 quarterly, either at the CBO (O-PoC) or an offsite community testing site (SoC). O-PoC will also receive COVID-19 mitigation counseling and education from the CHW. Our primary outcome is the proportion of SARS-CoV-2 tests performed with results received by participants. Secondary outcomes include adherence to mitigation behaviors and cost-effectiveness of the intervention. DISCUSSION: The MOSAIC study will offer insight into cost effective strategies for SARS-CoV-2 testing and education for CLS-involved individuals. The study will also contribute to the growing literature on CHW's role in health education, supportive counseling, and building trust between patients and healthcare organizations.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

"It doesn't make any sense to even try": the disruptive impact of COVID-19's first wave on people with chronic pain using medical cannabis in New York.

BACKGROUND: The COVID-19 pandemic disrupted health care but it is unknown how it impacted the lives of people using medical cannabis for chronic pain. OBJECTIVE: To understand the experiences of individuals from the Bronx, NY, who had chronic pain and were certified to use medical cannabis during the first wave of the COVID-19 pandemic. METHODS: We conducted 1:1 semi-structured qualitative telephone interviews from March through May 2020 with a convenience sample of 14 individuals enrolled in a longitudinal cohort study. We purposively recruited participants with both frequent and infrequent patterns of cannabis use. Interviews addressed the impact of the COVID-19 pandemic on daily life, symptoms, medical cannabis purchase, and use. We conducted a thematic analysis, with a codebook approach, to identify and describe prominent themes. RESULTS: Participants' median age was 49 years, nine were female, four were Hispanic, four were non-Hispanic White, and four were non-Hispanic Black. We identified three themes: (1) disrupted access to health services, (2) disrupted access to medical cannabis due to the pandemic, and (3) mixed impact of chronic pain on social isolation and mental health. Due to increased barriers to health care in general and to medical cannabis specifically, participants reduced medical cannabis use, stopped use, or substituted medical cannabis with unregulated cannabis. Living with chronic pain both prepared participants for the pandemic and made the pandemic more difficult. CONCLUSION: The COVID-19 pandemic amplified pre-existing challenges and barriers to care, including to medical cannabis, among people with chronic pain. Understanding pandemic-era barriers may inform policies in ongoing and future public health emergencies.

Factors Associated with Medical Cannabis Use After Certification: A Three-Month Longitudinal Study.

Background: Over the past decade, there has been increased utilization of medical cannabis (MC) in the United States. Few studies have described sociodemographic and clinical factors associated with MC use after certification and more specifically, factors associated with use of MC products with different cannabinoid profiles. Methods: We conducted a longitudinal cohort study of adults (N=225) with chronic or severe pain on opioids who were newly certified for MC in New York State and enrolled in the study between November 2018 and January 2022. We collected data over participants' first 3 months in the study, from web-based assessment of MC use every 2 weeks (unit of analysis). We used generalized estimating equation models to examine associations of sociodemographic and clinical factors with (1) MC use (vs. no MC use) and (2) use of MC products with different cannabinoid profiles. Results: On average, 29% of the participants used predominantly high delta-9-tetrahydrocannabinol (THC) MC products within the first 3 months of follow-up, 30% used other MC products, and 41% did not use MC products. Non-Hispanic White race, pain at multiple sites, and past 30-day sedative use were associated with a higher likelihood of MC use (vs. no MC use). Current tobacco use, unregulated cannabis use, and enrollment in the study during the COVID-19 pandemic were associated with a lower likelihood of MC use (vs. no MC use). Among participants reporting MC use, female gender and older age were associated with a lower likelihood of using predominantly high-THC MC products (vs. other MC products). Conclusion: White individuals were more likely to use MC after certification, which may be owing to access and cost issues. The findings that sedative use was associated with greater MC use, but tobacco and unregulated cannabis were associated with less MC use, may imply synergism and substitution that warrant further research. From the policy perspective, additional measures are needed to ensure equitable availability of and access to MC. Health practitioners should check patients' history and current use of sedative, tobacco, and unregulated cannabis before providing an MC recommendation and counsel patients on safe cannabis use. clinicaltrials.gov (NCT03268551).

Reducing Opioid Analgesic Prescribing in Dentistry Through Prescribing Defaults: A Cluster-Randomized Controlled Trial.

OBJECTIVE: To determine the effect of a uniform, reduced, default dispense quantity for new opioid analgesic prescriptions on the quantity of opioids prescribed in dentistry practices. METHODS: We conducted a cluster-randomized controlled trial within a health system in the Bronx, NY, USA. We randomly assigned three dentistry sites to a 10-tablet default, a 5-tablet default, or no change (control). The primary outcome was the quantity of opioid analgesics prescribed in the new prescription. Secondary outcomes were opioid analgesic reorders and health service utilization within 30 days after the new prescription. We analyzed outcomes from 6 months before implementation through 18 months after implementation. RESULTS: Overall, 6,309 patients received a new prescription. Compared with the control site, patients at the 10-tablet-default site had a significantly larger change in prescriptions for 10 tablets or fewer (38.7 percentage points; confidence interval [CI]: 11.5 to 66.0), lower number of tablets prescribed (-3.3 tablets; CI: -5.9 to -0.7), and lower morphine milligram equivalents (MME) prescribed (-14.1 MME; CI: -27.8 to -0.4), which persisted in the 30 days after the new prescription despite a higher percentage of reorders (3.3 percentage points; CI: 0.2 to 6.4). Compared with the control site, patients at the 5-tablet-default site did not have a significant difference in any outcomes except for a significantly higher percentage of reorders (2.6 percentage points; CI: 0.2 to 4.9). CONCLUSIONS: Our findings further support the efficacy of strategies that lower default dispense quantities, although they indicate that caution is warranted in the selection of the default. TRIAL REGISTRATION: ClinicalTrials.org ID: NCT03030469.

Medical Cannabis Use Patterns and Adverse Effects in Inflammatory Bowel Disease.

GOALS: To investigate medical cannabis (MC) use patterns and adverse effects in patients with inflammatory bowel disease (IBD). BACKGROUND: MC is now legal in many states. Although previous studies suggest improvement in disease activity among IBD patients using MC, use patterns and adverse effects are unclear. STUDY: A cross-sectional anonymous survey was conducted (October 23, 2020 to January 24, 2021) among patients accessing MC dispensaries in New York and Minnesota. Eligibility criteria: age 18 years or older, selfreported IBD diagnosis, MC dispensary purchase. Survey questions included IBD characteristics, MC and healthcare utilization, and MC effects/adverse events. Participant characteristics were analyzed with descriptive statistics. Utilization patterns and symptoms before and after MC use were compared using the Stuart Maxwell test. RESULTS: Of 236 respondents, overall IBD disease activity was mild-to-moderate. Most respondents (61.0%) took a biological. Median frequency of MC use was at least once within the past week. Most respondents used products with high Δ9-tetrahydrocannabinol content (87.5%) through vape pens/cartridges (78.6%). Respondents reported fewer emergency room visits in the 12 months after versus before MC use (35.2 vs 41.5%, P <0.01) and less impact of symptoms on daily life. Most respondents reported euphoria with MC use (75.4%). The other common side effects were feeling drowsy, groggy, or with memory lapses (4.2%), dry mouth/eyes (3.4%), and anxiety/depression or paranoia (3.4%). Few respondents reported MC diversion (1.3%). CONCLUSIONS: MC users with IBD perceive symptom benefits and report decreased emergency room visits without serious adverse effects. Further studies are needed to confirm these results with objective measures of healthcare utilization and disease activity.

U.S. state policies on opioid prescribing during the peak of the prescription opioid crisis: Associations with opioid overdose mortality.

BACKGROUND: In response to the opioid overdose crisis in the United States, many states implemented policies to guide opioid prescribing, but their impact on overdose mortality (prescription and non-prescription) remains poorly understood. We examined the impact of U.S. state opioid-prescribing policies on opioid overdose mortality following implementation. METHODS: We calculated opioid overdose mortality rates from 1999-2016 by U.S. state using the CDC WONDER database, overall and separately for overdose deaths from prescription and non-prescription opioids. For each state, policies active on 1/1/2014 were reviewed for the presence and strength of six provisions recommending judicious opioid prescribing practices; "strong" provisions used the words "should," "shall," or "must". Interrupted time series (ITS) tested the association of each strong provision with overdose mortality, overall and separately for prescription and non-prescription opioids, in the two years following implementation. Sensitivity analyses compared between states, used time-lagged analyses, and excluded synthetic opioids from non-prescription opioid deaths. RESULTS: All six provisions had consistent direction of effect in ITS and sensitivity analyses. Strong provisions for prescriber training and limits on opioid dose reduced the slope of overall and prescription opioid overdose mortality in both ITS and sensitivity analyses. Reduced non-prescription opioid overdose mortality was only associated with strong provision for prescriber training. Some provisions had a negative impact. In ITS, strong provision for prescriber response to misuse increased the slope of non-prescription opioid overdose mortality. Strong provision for mandatory prescription drug monitoring program use had no relationship with overdose mortality in ITS and was associated with increased overall, prescription and non-prescription opioid overdose mortality in between-state sensitivity analysis. CONCLUSION: Opioid prescribing policies in U.S. states at the peak of the prescription opioid epidemic had modest mortality benefit, and did not reduce non-prescription opioid overdose mortality. A strong provision for prescriber training was the only provision associated with reduced prescription and non-prescription opioid overdose mortality. These findings can inform future efforts addressing prescription drug epidemics.

Increasing Access to Safe Medical Cannabis: Establishment of a Medical Cannabis Program in a Safety-Net Academic Medical Center.

Despite numerous challenges, Montefiore Medical Center in New York City implemented a program aimed at providing comprehensive, evidence-based medical cannabis certifications to patients, including those who have been historically disenfranchised, and shares insights from five years of operation.

Availability of medical cannabis services by racial, social, and geographic characteristics of neighborhoods in New York: a cross-sectional study.

BACKGROUND: Within the United States (US), because racial/ethnic disparities in cannabis arrests continue, and cannabis legalization is expanding, understanding disparities in availability of legal cannabis services is important. Few studies report mixed findings regarding disparities in availability of legal cannabis services; none examined New York. We examined disparities in availability of medical cannabis services in New York. We hypothesized that New York census tracts with few Black or Hispanic residents, high incomes, high education levels, and greater urbanicity would have more medical cannabis services. METHODS: In this cross-sectional study, we used data from the 2018 US Census Bureau 5-year American Community Survey and New York Medical Marijuana Program. Main exposures were census tract characteristics, including urban-rural classification, percentage of Black and Hispanic residents, percentage of residents with bachelor's degrees or higher, and median household income. Main outcomes were presence of at least one medical cannabis certifying provider and dispensary in each census tract. To compare census tracts' characteristics with (vs. without) certifying providers and dispensaries, we used chi-square tests and t-tests. To examine characteristics independently associated with (vs. without) certifying providers, we used multivariable logistic regression. RESULTS: Of 4858 New York census tracts, 1073 (22.1%) had medical cannabis certifying providers and 37 (0.8%) had dispensaries. Compared to urban census tracts, suburban census tracts were 62% less likely to have at least one certifying provider (aOR = 0.38; 95% CI = 0.25-0.57). For every 10% increase in the proportion of Black residents, a census tract was 5% less likely to have at least one certifying provider (aOR = 0.95; 95% CI = 0.92-0.99). For every 10% increase in the proportion of residents with bachelor's degrees or higher, a census tract was 30% more likely to have at least one certifying provider (aOR = 1.30; 95% CI = 1.21-1.38). Census tracts with (vs. without) dispensaries were more likely to have a higher percentage of residents with bachelor's degrees or higher (43.7% vs. 34.1%, p < 0.005). CONCLUSIONS: In New York, medical cannabis services are least available in neighborhoods with Black residents and most available in urban neighborhoods with highly educated residents. Benefits of legal cannabis must be shared by communities disproportionately harmed by illegal cannabis.

Cascade of care for office-based buprenorphine treatment in Bronx community clinics.

INTRODUCTION: The cascade of care for opioid use disorder (OUD) has been described at the population level to inform health policy and in health care systems, programs, and communities to guide targeted interventions. Office-based buprenorphine treatment is essential for expanding access to OUD treatment; however, few studies examine the cascade of care specifically for office-based buprenorphine treatment. Our objective was to describe a cascade of care for patients referred for office-based buprenorphine treatment in the primary care setting. METHODS: We conducted a retrospective cohort study of patients with OUD who were referred for office-based buprenorphine treatment within a large, urban health care system between 2018 and 2019. Our primary outcomes included completion of each step of the buprenorphine treatment cascade of care: 1) referred for treatment, 2) scheduled initial visit, 3) completed initial visit, 4) initiated buprenorphine treatment, and 5) retained in treatment at 90 days. We constructed a cascade of care by calculating proportions of patients identified at every step, starting with the total number of patients referred for treatment as the first step. We extracted data from the program's referral database and electronic medical record system. We compared characteristics of patients referred who initiated buprenorphine to those referred who did not initiate buprenorphine treatment using chi-squared tests and t-tests. To account for the hierarchical nature of the data, we conducted a Generalized Estimating Equation (GEE) modeling to test the differences in attrition rates among the steps of the cascade of care. RESULTS: In the 24-month period between 2018 and 2019, 226 patients were referred for office-based buprenorphine treatment at Montefiore's Buprenorphine Treatment Network. Patients' mean age at referral was 47 years, and most were male (68.6%), Hispanic (49.6%), and publicly insured (75.7%). Among all patients, 182 (80.5%) were scheduled for an initial visit, 142 (62.8%) completed the initial visit, 134 (59.3%) initiated buprenorphine treatment, and 95 (42.0%) were retained in treatment at 90 days. 37.2% of all patients referred did not complete the initial visit. A GEE model showed that attrition is significantly steeper in the first two steps of the cascade of care, compared to the later three steps (AOR = 1.95, 95% CI = 1.31-2.91, p < 0.05). Compared to referred patients who did not initiate treatment, those referred who initiated treatment were more likely to be using non-prescribed buprenorphine at time of referral (19.4% vs. 5.4%, p < 0.05) and be self-referred (22.4% vs. 9.8%, p < 0.05). CONCLUSION: Our study is the first to describe a cascade of care for office-based buprenorphine treatment in a large health care system. The study observed the steepest attrition in the first two steps of the cascade of care, where more than a third of patients referred did not complete the initial visit. Patients who were self-referred, or using non-prescribed buprenorphine were more likely to initiate treatment. A cascade of care specific for office-based buprenorphine can inform future efforts to improve linkage to care.

Clinical Management of Opioid Withdrawal.

Appropriate clinical management of opioid withdrawal is a crucial bridge to long-term treatment for opioid use disorder (OUD), because it is a high-risk time for potential opioid overdose and relapse. We provide a narrative review of evidence-based opioid withdrawal management strategies applicable to a variety of treatment settings and geographies. The goals of opioid withdrawal management include relieving suffering associated with withdrawal, providing appropriate diagnosis and screening, engaging patients in initiation of OUD treatment, and using harm reduction strategies, all guided by a patient-centered approach to care. In addition, we discuss complex cases, relapse prevention strategies, and new developments in opioid withdrawal management.

Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale.

BACKGROUND: Despite dramatic increases in opioid use disorder (OUD) and overdose deaths, the U.S. has been unable to consistently deliver OUD treatment to those who need it. Syringe services programs (SSPs) can engage an out-of-treatment population of people with OUD that has elevated overdose risk. Buprenorphine treatment is safe and effective, and US regulations allow for prescribing from diverse locations, including SSPs. This study's objective is to test buprenorphine treatment initiation at SSPs. We hypothesize that offering onsite buprenorphine treatment initiation will improve OUD treatment engagement without reducing buprenorphine treatment effectiveness or safety. METHODS: We will recruit 250 out-of-treatment SSP participants with OUD in a large urban area. Participants will be randomized to onsite buprenorphine treatment initiation or enhanced referral. Over 2 weeks, participants in the onsite treatment arm will see a buprenorphine provider twice at the SSP, receive weekly medication packs, and then their care will be transferred to a community health center for treatment continuation. In the control arm, within one week, participants will receive an appointment at the same community health center as in the intervention arm for buprenorphine initiation and continuation. Participants will be assessed with urine drug tests, questionnaires, and medical record review. The primary outcome will be engagement in buprenorphine treatment at 30 days. Secondary outcomes include buprenorphine diversion, opioid-free urine drug tests, and intervention cost-effectiveness. DISCUSSION: Our study will contribute to the growing literature on SSPs as a conduit to OUD treatment. SSPs hold promise to deliver needed care to people with OUD.

A comparison of office-based buprenorphine treatment outcomes in Bronx community clinics before versus during the COVID-19 pandemic.

INTRODUCTION: In 2020, the US and New York City experienced unprecedented deaths due to the COVID-19 pandemic and drug overdoses. Policy changes reduced burdensome regulations for medication treatment for opioid use disorder (OUD). Despite these policy changes, few studies examined buprenorphine treatment outcomes during the pandemic. We compared treatment outcomes among Bronx patients referred to office-based buprenorphine treatment before versus during the pandemic. METHODS: In a retrospective cohort study, we compared patients referred to buprenorphine treatment in a Bronx community clinic before (March-August 2019) versus during (March-August 2020) the pandemic. We describe changes to buprenorphine treatment during the pandemic, including telehealth and prioritizing harm reduction. Using data from medical records and program logs, main outcomes included steps of the OUD treatment cascade of care-initial visit scheduled and completed, treatment initiated, and retained in treatment at 90 days. Using chi square and t-tests, we examined differences in patient characteristics and OUD treatment cascade steps before versus during the pandemic. RESULTS: Before and during the pandemic, 72 and 35 patients were referred to buprenorphine treatment, respectively. Patients' mean age was 46 years, most were male (67.3%) or Hispanic (52.3%), and few had private insurance (19.6%). Patients referred during (vs. before) the pandemic were more likely to have private insurance (31.4% vs. 13.9%, p < 0.05) and be referred from acute care settings (37.1% vs. 19.4%, p < 0.05). No significant differences in OUD cascade of care outcomes existed between those referred during versus before the pandemic. However, among patients who initiated buprenorphine treatment, those referred during (vs. before) the pandemic were more likely to be retained in treatment at 90 days (68.0% vs. 42.9%, p < 0.05). CONCLUSIONS: Despite the COVID-19 pandemic's unprecedented devastation to the Bronx, along with worsening drug overdose deaths, OUD cascade of care outcomes were similar among patients referred to buprenorphine treatment before versus during the pandemic. Among patients who initiated buprenorphine treatment, treatment retention was better during (versus before) the pandemic. During a public health emergency, incorporating telehealth and prioritizing harm reduction are key strategies to maintain optimal OUD treatment outcomes.