Extended-Release 7-Day Injectable Buprenorphine for Patients With Minimal to Mild Opioid Withdrawal.

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

Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial.

INTRODUCTION: There is uncertainty about whether criminal legal involvement (CLI) impacts the effectiveness of medications for opioid use disorder (MOUD). We aimed to determine whether CLI modifies the association between buprenorphine-naloxone (BUP-NX) vs. extended-release naltrexone (XR-NTX) and MOUD treatment outcomes. METHODS: We conducted a secondary analysis of X:BOT, a 24-week multi-center randomized controlled trial comparing treatment outcomes between BUP-NX (n = 287) and XR-NTX (n = 283) in the general population. We used baseline Additional Severity-Index Lite responses to identify patients with recent CLI (n = 342), defined as active CLI and/or CLI in the past 30 days, and lifetime incarceration (n = 328). We explored recent CLI and lifetime incarceration as potential effect modifiers of BUP-NX vs. XR-NTX effectiveness on relapse, induction, and overdose. We conducted both intention-to-treat and per-protocol analyses for each outcome. RESULTS: In intention-to-treat analyses, recent CLI modified the effect of BUP-NX vs. XR-NTX on odds of successful induction (p = 0.03) and hazard of overdose (p = 0.04), but it did not modify the effect on hazard of relapse (p = 0.23). All participants experienced lower odds of successful induction with XR-NTX compared to BUP-NX, but the relative likelihood of successful induction with BUP-NX was lower than XR-NTX among individuals with recent CLI (OR: 0.25, 95 % CI: 0.13-0.47, p < 0.001) compared to those without recent CLI (OR: 0.04, 95 % CI: 0.01-0.19, p < 0.001). Participants with recent CLI experienced similar hazard of overdose with XR-NTX and BUP-NX (HR: 1.12, 95 % CI: 0.42-3.01, p = 0.82), whereas those without recent CLI experienced greater hazard of overdose with XR-NTX compared to BUP-NX (HR: 12.60, 95 % CI: 1.62-98.03, p = 0.02). In per-protocol analyses, recent CLI did not modify the effect of MOUD on hazard of overdose (p = 0.10) or relapse (p = 0.41). Lifetime incarceration did not modify any outcome. CONCLUSIONS: Compared to individuals without recent CLI, individuals with recent CLI experienced decreased relative effectiveness of BUP-NX compared to XR-NTX for induction and overdose outcomes. This highlights the importance of considering the impact of recent CLI on opioid use disorder treatment outcomes. Future research should explore the mechanisms through which recent CLI modifies MOUD effectiveness and aim to improve MOUD effectiveness for individuals with recent CLI.

Prescription Opioid Dose Change Prior to Fatal Opioid-Detected Overdose.

BACKGROUND: The opioid overdose crisis continues within the U.S., and the role of prescribed opioids and prescribing patterns in overdose deaths remains an important area of research. This study investigated patterns of prescription opioids dispensed in the 12 months prior to opioid-detected overdose death in Connecticut between May 8th, 2016 and January 2nd, 2018, considering differences by demographic characteristics. METHODS: The sample included decedents who had an opioid dispensed within 30 days preceding death. Using multilevel modeling, we estimated the slope of change in mean morphine equivalent (MME) daily dose over 12 months prior to death, considering linear and quadratic effects of time. We estimated the main effects of age, sex, race, and ethnicity and their interactions with time on MME. A sensitivity analysis examined how excluding decedents who did not receive long-term (≥90 days) opioid therapy affected mean MME slopes. Secondary analysis explored differences by toxicology results. RESULTS: Among 1,580 opioid-detected deaths, 179 decedents had prescribed opioids dispensed within 30 days preceding death. Decedents' mean age was 47.3 years (±11.5), 65.5% were male, 81% White non-Hispanic, 9.5% Black non-Hispanic, and 9.5% Hispanic. In the time-only model, linear (ß=6.25, p<0.01) and quadratic (ß=0.49, p=0.02) effects of time were positive, indicating exponentially increasing dose prior to death. Linear change in MME was significantly attenuated in men compared to women (ß=-4.87, p=0.03); however, men were more likely to have non-prescription opioids in their toxicology results (p=0.02). Sensitivity analysis results supported primary findings. CONCLUSION: Rapid dose increases in dispensed opioids may be associated with opioid-detected overdose deaths, especially among women.

Stepped Care for Patients to Optimize Whole Recovery (SC-POWR): An Effectiveness Trial Evaluating a Stepped Care Model for Individuals With Opioid Use Disorder and Chronic Pain.

Many patients who receive treatment for opioid use disorder (OUD) report experiencing chronic pain (CP), which is associated with high levels of ongoing nonmedical opioid use and low retention in OUD treatment. In pilot studies of patients with OUD receiving buprenorphine or methadone who had CP, cognitive behavioral therapy (CBT) attenuated nonmedical opioid use compared with treatment-as-usual (TAU), but patients in both treatment arms exhibited similar pain improvements. Adding exercise and stress reduction to this model may augment pain-related outcomes. With funding from National Institutes of Health, we plan to conduct a randomized clinical trial of 316 patients with OUD and CP to test the effectiveness of TAU compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce nonmedical opioid use and pain (primary outcomes) (Aim 1) and decrease pain intensity and interference, alcohol use, anxiety, depression and stress, and improve sleep (secondary outcomes) (Aim 2). Eligible participants will be randomized to receive TAU (buprenorphine or methadone and at least once a month individual or group counseling) or SC-POWR (ie, TAU and up to 12 CBT sessions) for 24 weeks. Based on prespecified nonresponse criteria, SC-POWR may be stepped up at week 6 to receive onsite weekly group sessions of exercise (Wii Fit, Tai Chi) and "stepped up" again at week 15 to receive weekly group sessions of stress reduction (relaxation training, auricular acupuncture). They will be followed for another 24 weeks to evaluate durability of treatment response for illicit opioid use, alcohol use, pain, anxiety, depression, stress, sleep, and retention in medications for OUD (Aim 3).

Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations.

BACKGROUND: Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. METHODS: This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site's capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). DISCUSSION: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients' access to MOUD and treatment outcomes. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www. CLINICALTRIALS: gov/study/NCT05310786?id=NCT05310786&rank=1.

Accessibility of Opioid Treatment Programs Based on Conventional vs Perceived Travel Time Measures.

Importance: Transportation barriers have long been associated with poorer health outcomes; this burden is especially acute for individuals with opioid use disorder (OUD), a chronic disease often associated with low socioeconomic status. Conventional travel time analyses may not fully account for experiential components of travel, thereby understating the true travel burden and overstating treatment accessibility to opioid treatment programs (OTPs). Objective: To develop a metric of feels-like accessibility for those using public transit to access OTPs that accounts for the realistic travel burden on individuals with OUD. Design, Setting, and Participants: This cross-sectional study integrated high-resolution transit schedules and operating hours of OTPs to measure feels-like accessibility. Feels-like accessibility considers the differential outcomes of out-of-vehicle travel components and more realistically reflects individuals' transportation burden than conventional accessibility measures. Gini indices and spatial regression models were used to investigate inequities in accessibility. Geocoded data for residential addresses of 1018 overdose fatalities in Connecticut in 2019 were used as a proxy for the treatment needs of individuals with OUD. Data were analyzed between May and August 2023. Main Outcomes and Measures: Conventional and feels-like accessibility scores. Exposures: Fluctuations in public transit frequencies over the course of the day and the limited operating hours of the OTPs. Results: Of the 1018 individuals in the study, the mean (SD) age at death was 43.7 (12.6) years, 784 individuals (77%) were men, 111 (11%) were African American, and 889 (87%) were White, with other racial and ethnic categories including 18 individuals (2%). A total of 264 individuals in the sample (26%) could not access an OTP within 180 minutes. For those who could access these facilities, the average 1-way travel time was 45.6 minutes, with individuals spending approximately 70% of their trip duration on out-of-vehicle travel components. The conventional accessibility metric underestimates individuals' travel burden to OTPs as well as the inequity in accessibility compared with the feels-like accessibility metric. For example, the median (range) conventional accessibility score, defined as the number of OTPs within 120 minutes of transit travel time, was 5.0 (0.0-17.0); the median (range) feels-like accessibility score, defined as the number of OTPs within 120 minutes of transit travel time weighted to account for in- and out-of-vehicle segments, was 1.0 (0.0-10.0). There is a considerable temporal variation in travel time and accessibility depending on the departure times. Conclusions and Relevance: In this cross-sectional study of travel burdens, the calculated feels-like accessibility scores, which consider the differential outcomes of out-of-vehicle travel components (eg, walking and waiting), could better and more realistically reflect passengers' transportation burden. Policy recommendations derived from the conventional accessibility metric could be misleading, and decision-makers should use feels-like accessibility metrics that adequately capture individuals' travel burdens. In the context of access to OTPs, the findings from this study suggest that opening new OTP sites to address gaps in access due to distance to services or extending hours of operation at existing sites may ameliorate the travel burden for individuals.

Receipt of opioid use disorder treatments prior to fatal overdoses and comparison to no treatment in Connecticut, 2016-17.

OBJECTIVE: To determine the relative risk of death following exposure to treatments for OUD compared to no treatment. METHODS: In this retrospective cohort study we compiled and merged state agency data on accidental and undetermined opioid overdose deaths in 2017 and exposures to OUD treatment in the prior six months to determine incidence rates following exposure to different treatment modalities. These rates were compared to the estimated incidence among those exposed to no treatment to determine relative risk of death for each treatment exposure. RESULTS: Incidence rates for opioid poisoning deaths for those exposed to treatment ranged from 6.06±1.40 per 1000 persons exposed to methadone to 17.36±3.22 per 1000 persons exposed to any non-medication treatment. The estimated incidence rate for those not exposed to treatment was 9.80±0.72 per 1000 persons. With no exposure to treatment as referent, exposure to methadone or buprenorphine reduced the relative risk by 38% or 34%, respectively; the relative risk of non-medication treatments was equal to or worse than no exposure to treatment (RR = 1.27-1.77). PRINCIPAL CONCLUSIONS: Exposure to non-MOUD treatments provided no protection against fatal opioid poisoning whereas the relative risk was reduced following exposures to MOUD treatment, even if treatment was not continued. Population level efforts to reduce opioid overdose deaths need to focus on expanding access to agonist-based MOUD treatments and are unlikely to succeed if access to non-MOUD treatments is made more available.

Facilitation and Preferred Models for Delivering Substance Use Disorder Treatment in HIV Clinics: Results From a Multisite Randomized Trial.

BACKGROUND: Integrated addiction treatment in HIV clinics is associated with improved outcomes, yet it is offered inconsistently and with variable models of care. We sought to evaluate the impact of Implementation Facilitation ("Facilitation") on clinician and staff preference for provision of addiction treatment in HIV clinics with on-site resources (all trained or designated on-site specialist) versus outside resources (outside specialist or refer out). METHODS: From July 2017 to July 2020, surveys assessed clinician and staff preferences for addiction treatment models during control (ie, baseline), intervention, evaluation, and maintenance phases in 4 HIV clinics in the Northeast United States. RESULTS: During the control phase, among 76 respondents (response rate, 58%), the proportions who preferred treatment with on-site resources for opioid use disorder (OUD), alcohol use disorder (AUD), and tobacco use disorder (TUD) were 63%, 55%, and 63%, respectively. Compared with control, there were no significant differences in preferred model during the intervention and evaluation phases except for AUD where there was an increased preference for treatment with on-site resources in the intervention versus control phase. Compared with control, during the maintenance phase, a higher proportion of clinicians and staff preferred providing addiction treatment with on-site resources versus outside resources: OUD, 75% (odds ratio [OR; 95% confidence interval {CI}], 1.79 [1.06-3.03]); AUD, 73% (OR [95% CI], 2.23 [1.36-3.65]), and TUD, 76% (OR [95% CI], 1.88 [1.11-3.18]). CONCLUSIONS: The findings from this study lend support for "Facilitation" as a strategy to enhance clinician and staff preference for integrated addiction treatment in HIV clinics with on-site resources.

Associations between Patient Experience and Addiction Treatment Facility Services: Results of the Addiction Treatment Locator, Assessment, and Standards Surveys.

OBJECTIVES: Patient experience and presence of evidence-based facility services are 2 dimensions of assessing quality of addiction treatment facilities. However, the relationship between these two is not well described. The objective of this study was to explore associations between patient experience measures and service offerings at addiction treatment facilities. METHODS: We used data from cross-sectional surveys of addiction treatment facilities and persons involved in treatment at corresponding facilities to identify facility services (eg, availability of medications for alcohol use disorder, assistance with obtaining social services, etc) and patient experience measures (overall facility rating, extent helped by treatment, ability to deal with daily problems after treatment), respectively. We used hierarchical multiple logistic regression to test for associations between top-box scores for each patient experience outcome and facility services. RESULTS: We analyzed 9191 patient experience surveys from 149 facilities. Assistance with obtaining social services (adjusted odds ratio [95% confidence interval], 0.43 [0.28-0.66]) was associated with lower overall treatment facility ratings. Childcare (2.00 [1.04-3.84]) was associated with top-box scores for extent helped. Availability of cognitive behavioral therapy (2.67 [1.25-5.73]) and childcare (1.77 [1.08-2.92]) were associated with top-box scores for ability to deal with daily problems after treatment. Assistance with obtaining social services (0.61 [0.41-0.90]) was associated with lower scores for ability to deal with problems after treatment. CONCLUSIONS: Few addiction treatment facility services were associated with patient experience measures. Future work should explore bridging the gap between evidence-based services and positive patient experiences.

Drive Time to Addiction Treatment Facilities Providing Contingency Management across Rural and Urban Census Tracts in 6 US States.

OBJECTIVE: We examined drive times to outpatient substance use disorder treatment providers that provide contingency management (CM) and those that integrate CM with medication for opioid use disorder (MOUD) services in 6 US states. METHODS: We completed cross-sectional geospatial analysis among census tracts in Delaware, Louisiana, Massachusetts, North Carolina, New York, and West Virginia. We excluded census tracts with a population of zero. Using data from the 2020 Shatterproof substance use treatment facility survey, our outcome was the minimum drive time in minutes from the census tract mean center of population to the nearest outpatient CM provider, outpatient CM provider with MOUD services, and federally qualified health centers (FQHC). We stratified census tracts by 2010 Rural-Urban Commuting Area codes and by state. RESULTS: The population was greater than zero in 11,719 of 11,899 census tracts. The median drive time to the nearest CM provider was 12.2 [interquartile range (IQR), 7.0-23.5) minutes and the median drive time to the nearest CM provider increased from 9.7 (IQR, 6.0-15.0) minutes in urban census tracts to 38.8 (IQR, 25.4-53.0) minutes in rural ( H = 3683, P < 0.001). The median drive time increased to the nearest CM provider with MOUD services [14.2 (IQR, 7.9-29.5) minutes, W = 18,877, P < 0.001] and decreased to the nearest FQHC [7.9 (IQR, 4.3-13.6) minutes, W = 11,555,894, P < 0.001]. CONCLUSIONS: These results suggest limited availability of CM, particularly within rural communities and for patients needing concurrent CM and MOUD treatment. Our results suggest greater adoption of CM within FQHCs could reduce urban-rural disparities in CM availability.

URINE TOXICOLOGY PROFILES OF EMERGENCY DEPARTMENT PATIENTS WITH UNTREATED OPIOID USE DISORDER: A MULTI-SITE VIEW.

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

Alcohol Use and Sustained Virologic Response to Hepatitis C Virus Direct-Acting Antiviral Therapy.

Importance: Some payers and clinicians require alcohol abstinence to receive direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection. Objective: To evaluate whether alcohol use at DAA treatment initiation is associated with decreased likelihood of sustained virologic response (SVR). Design, Setting, and Participants: This retrospective cohort study used electronic health records from the US Department of Veterans Affairs (VA), the largest integrated national health care system that provides unrestricted access to HCV treatment. Participants included all patients born between 1945 and 1965 who were dispensed DAA therapy between January 1, 2014, and June 30, 2018. Data analysis was completed in November 2020 with updated sensitivity analyses performed in 2023. Exposure: Alcohol use categories were generated using responses to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for alcohol use disorder (AUD): abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD. Main Outcomes and Measures: The primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% CIs of SVR associated with alcohol category. Results: Among 69 229 patients who initiated DAA therapy (mean [SD] age, 62.6 [4.5] years; 67 150 men [97.0%]; 34 655 non-Hispanic White individuals [50.1%]; 28 094 non-Hispanic Black individuals [40.6%]; 58 477 individuals [84.5%] with HCV genotype 1), 65 355 (94.4%) achieved SVR. A total of 32 290 individuals (46.6%) were abstinent without AUD, 9192 (13.3%) were abstinent with AUD, 13 415 (19.4%) had lower-risk consumption, 3117 (4.5%) had moderate-risk consumption, and 11 215 (16.2%) had high-risk consumption or AUD. After adjustment for potential confounding variables, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD (OR, 0.95; 95% CI, 0.85-1.07). There was no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P for interaction = .30). Conclusions and Relevance: In this cohort study, alcohol use and AUD were not associated with lower odds of SVR. Restricting access to DAA therapy according to alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals.

Availability of Specific Programs and Medications for Addiction Treatment to Vulnerable Populations: Results from the Addiction Treatment Locator, Assessment, and Standards (ATLAS) Survey.

OBJECTIVES: This study aimed to describe addiction treatment facilities by their offerings of medications for alcohol use disorder (MAUD) and/or for opioid use disorder (MOUD), and by their offering services to groups with barriers to care: uninsured and publicly insured, youth, seniors, individuals preferring to receive care in Spanish, and sexual minority individuals. METHODS: We examined addiction treatment facility survey data in 6 US states. We performed bivariate analyses comparing facilities that offered MAUD, MOUD, and both (main outcomes). We then constructed a multivariable model to identify predictors of offering MAUD, MOUD, or both, including exposures that demonstrate programming for special populations. RESULTS: Among 2474 facilities, 1228 (50%) responded between October 2019 and January 2020. Programs were offered for youth (30%), elderly (40%), Spanish-speaking (37%), and sexual minority populations (39%), with 58% providing MAUD, 67% providing MOUD, and 56% providing both. Among those providing MAUD, MOUD, or both, a majority (>60% for all exposures) offered programming to vulnerable populations. With Delaware as reference, Louisiana (adjusted odds ratio [aOR], 0.28; 95% confidence interval [CI], 0.12-0.67) and North Carolina (aOR, 0.33; 95% CI, 0.15-0.72) facilities had lesser odds of offering both MAUD and MOUD. All exposures identifying facilities offering treatment to vulnerable groups were associated with offerings of MAUD and/or MOUD except for offerings to youth; these facilities had less odds of offering MOUD (aOR, 0.31; 95% CI, 0.31-0.62). CONCLUSIONS: There are facility-level disparities in providing MAUD and MOUD by state, and facilities with youth programming have lesser odds of offering MOUD than other facilities.

Perspectives on contingency management for alcohol use and alcohol-associated conditions among people in care with HIV.

BACKGROUND: Contingency management (CM) is an evidence-based approach for reducing alcohol use; however, its implementation into routine HIV primary care-based settings has been limited. We evaluated perspectives on implementing CM to address unhealthy alcohol use and associated conditions for people with HIV in primary care settings. METHODS: From May 2021 to August 2021, we conducted two focus groups with staff involved in delivering the intervention (n = 5 Social Workers and n = 4 Research Coordinators) and individual interviews (n = 13) with a subset of participants involved in the multi-site Financial Incentives, Randomization, and Stepped Treatment (FIRST) trial. Qualitative data collection and analyses were informed by the Promoting Action on Research Implementation in Health Service (PARIHS) implementation science framework, including evidence (perception of CM), context (HIV primary care clinic and CM procedures), and facilitation (feasibility outside the research setting). RESULTS: Several major themes were identified. Regarding the evidence, participants lacked prior experience with CM, but the intervention was well received and, by some, perceived to lead to lasting behavior change. Regarding the clinical context for the reward schedule, the use of biochemical testing, specifically fingerstick phosphatidylethanol testing, and the reward process were perceived to be engaging and gratifying for both staff and patients. Participants indicated that the intervention was enhanced by its co-location within the HIV clinic. Regarding facilitation, participants suggested addressing the intervention's feasibility for non-research use, simplifying the reward structure, and rewarding non-abstinence in alcohol use. CONCLUSIONS: Among patients and staff involved in a clinical trial, CM was viewed as a helpful, positive, and feasible approach to addressing unhealthy alcohol use and related conditions. To enhance implementation, future efforts may consider simplified approaches to the reward structure and expanding rewards to non-abstinent reductions in alcohol consumption.

Efficacy of alcohol reduction interventions among people with HIV as evaluated by self-report and a phosphatidylethanol (PEth) outcome: protocol for a systematic review and individual participant data meta-analysis.

INTRODUCTION: Unhealthy alcohol use is associated with a range of adverse outcomes among people with HIV (PWH). Testing the efficacy and promoting the availability of effective interventions to address unhealthy alcohol use among PWH is thus a priority. Alcohol use outcomes in intervention studies are often measured by self-report alone, which can lead to spurious results due to information biases (eg, social desirability). Measuring alcohol outcomes objectively through biomarkers, such as phosphatidylethanol (PEth), in addition to self-report has potential to improve the validity of intervention studies. This protocol outlines the methods for a systematic review and individual participant data meta-analysis that will estimate the efficacy of interventions to reduce alcohol use as measured by a combined categorical self-report/PEth variable among PWH and compare these estimates to those generated when alcohol is measured by self-report or PEth alone. METHODS AND ANALYSIS: We will include randomised controlled trials that: (A) tested an alcohol intervention (behavioural and/or pharmacological), (B) enrolled participants 15 years or older with HIV; (C) included both PEth and self-report measurements, (D) completed data collection by 31 August 2023. We will contact principal investigators of eligible studies to inquire about their willingness to contribute data. The primary outcome variable will be a combined self-report/PEth alcohol categorical variable. Secondary outcomes will include PEth alone, self-report alone and HIV viral suppression. We will use a two-step meta-analysis and random effects modelling to estimate pooled treatment effects; I2 will be calculated to evaluate heterogeneity. Secondary and sensitivity analyses will explore treatment effects in adjusted models and within subgroups. Funnel plots will be used to explore publication bias. ETHICS AND DISSEMINATION: The study will be conducted with deidentified data from completed randomised controlled trials and will be considered exempt from additional ethical approval. Results will be disseminated through peer-reviewed publications and international scientific meetings. PROSPERO REGISTRATION NUMBER: CRD42022373640.

Perspectives of Clinicians and Staff at Community-Based Opioid Use Disorder Treatment Settings on Linkages With Emergency Department-Initiated Buprenorphine Programs.

Importance: An increasing number of emergency departments (EDs) are initiating buprenorphine for opioid use disorder (OUD) and linking patients to ongoing community-based treatment, yet community-based clinician and staff perspectives regarding this practice have not been characterized. Objective: To explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions. Design, Setting, and Participants: This qualitative study reports findings from Project ED Health, a hybrid type 3 effectiveness-implementation study designed to evaluate the impact of implementation facilitation on ED-initiated buprenorphine with referral to ongoing medication treatment. Clinicians and staff from community-based treatment programs were identified by urban academic EDs as potential referral sites for ongoing OUD treatment in 4 cities across the US in a formative evaluation as having the capability to continue medication treatment. Focus groups were held from April 1, 2018, to January 11, 2019, to examine community OUD treatment clinician and staff perspectives on accepting patients who have received ED-initiated buprenorphine. Data were analyzed from August 2020 to August 2022. Main Outcomes and Measures: Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework, focusing on domains including evidence, context, and facilitation. Results: A total of 103 individuals (mean [SD] age, 45.3 [12.0] years; 76 female and 64 White) participated in 14 focus groups (groups ranged from 3-22 participants). Participants shared negative attitudes toward buprenorphine and variable attitudes toward ED-initiated buprenorphine. Prominent barriers included the community site treatment capacity and structure as well as payment and regulatory barriers. Perceived factors that could facilitate this model included additional substance use disorder training for ED staff, referrals and communication, greater inclusion of peer navigators, and addressing sociostructural marginalization that patients faced. Conclusions and Relevance: In this study of community-based clinicians and staff positioned to deliver OUD treatment, participants reported many barriers to successful linkages for patients who received ED-initiated buprenorphine. Strategies to improve these linkages included educating communities and programs, modeling low-barrier philosophies, and using additional staff trained in addiction as resources to improve transitions from EDs to community partners.

National Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder.

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

Perspectives on and experiences of emergency department-initiated buprenorphine among clinical pharmacists: A multi-site qualitative study.

INTRODUCTION: Clinical pharmacists are well positioned to enhance efforts to promote emergency department (ED)-initiated buprenorphine to treat opioid use disorder (OUD). Among clinical pharmacists in urban EDs, we sought to characterize barriers and facilitators for ED-initiated buprenorphine to inform future implementation efforts and enhance access to this highly effective OUD treatment. METHODS: This study was conducted as a part of Project ED Health (CTN-0069, NCT03023930), a multisite effectiveness-implementation study aimed at promoting ED-initiated buprenorphine that was conducted between April 2017 and July 2020. Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) framework to assess perspectives on the relationship between 3 elements: evidence for buprenorphine, the ED context, and facilitation needs to promote ED-initiated buprenorphine. The study used an iterative coding process to identify overlapping themes within these 3 domains. RESULTS: The study conducted eight focus groups/interviews across four geographically disparate EDs with 15 pharmacist participants. We identified six themes. Themes related to evidence included (1) varied levels of comfort and experience among pharmacists with ED-initiated buprenorphine that increased over time and (2) a perception that patients with OUD have unique challenges that require guidance to optimize ED care. With regards to context, clinical pharmacists identified: (3) their ability to clarify scope of ED care in the context of unique pharmacology, formulations, and regulations of buprenorphine to ED staff, and that (4) their presence promotes successful program implementation and quality improvement. Participants identified facilitation needs including: (5) training to promote practice change and (6) ways to leverage already existing pharmacy resources outside of the ED. CONCLUSION: Clinical pharmacists play a unique and critical role in the efforts to promote ED-initiated buprenorphine. We identified 6 themes that can inform pharmacist-specific interventions that could aid in the successful implementation of this practice.

Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial.

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