Adverse Events at 1 Month Following Medication Initiation for Opioid Use Disorder Among Adolescents and Young Adults.

BACKGROUND: We assess adverse events (AEs) following medication initiation for adolescents and young adults with opioid use disorder (OUD). METHODS: This is a secondary analysis of a clinical trial of long-acting injectable naltrexone (LAI-naltrexone) among youth with OUD aged 15 to 21 years. Participants were recruited from residential treatment and placed into 1 of 3 treatment groups based on medication receipt at time of discharge (no medication, sublingual buprenorphine-naloxone [buprenorphine], or LAI-naltrexone). Frequencies and percentages of AEs by body system were compared by medication group at the 1-month follow-up visit. Logistic regression was used to compare groups on their likelihood of reporting an AE, overall and excluding injection site reactions. RESULTS: Of 199 participants, 71 (36%) received no medication, 59 (30%) buprenorphine, and 69 (35%) LAI-naltrexone at discharge. Participants who received LAI-naltrexone experienced more AEs, primarily due to injection site reactions (62%, accounting for 43% of all AEs among participants who received LAI-naltrexone). There were 6 reports of nonlethal overdose, 5 in the no medication, 1 in the buprenorphine, and none in the LAI-naltrexone group. Participants receiving LAI-naltrexone were more likely to report an AE compared to the other groups (P = .04), but this difference was no longer significant when excluding injection site reactions (P = .82). CONCLUSIONS: Excluding injection site reactions, there were no significant differences in the likelihood of reporting an AE 1 month after receiving LAI-NTX, buprenorphine, and no medications. LAI-naltrexone should be among the medications offered for the treatment of OUD in youth.

Experience Starting an Addiction Medicine Practice-Based Research Network.

OBJECTIVES: This paper outlines the experience developing Addiction Medicine Practice-Based Research Network (AMNet), which promotes the adoption of patient-reported outcome measures (PROMs) and measurement-based care in outpatient addiction treatment practices and creates a platform for quality improvement and research. METHODS: From August 2019 to July 2023, the AMNet team selected patient-reported outcome measures for implementation in the American Psychiatric Association's clinical data registry (PsychPRO), recruited addiction medicine providers, and collected PROMs data. RESULTS: AMNet selected 12 PROMs for implementation in PsychPRO. Through July 2023, 1565 providers expressed interest, of whom 216 of the 929 eligible providers (23%) attended an onboarding call/webinar. Two hundred six providers (95%) from 54 practices returned Participation Agreements. Subsequently, 65 providers (32%) from 39 practices withdrew, resulting in 141 (68%) providers from 15 practices. From November 2020 to July 2023, 38 providers submitted PROMs data using 1 of 3 PsychPRO patient portals. Sixteen of the 53 providers (30%) who signed up for the initial portal collected data from 468 patients. As of July 2023, 83 of the 141 providers (59%) opted to submit PROMs data from their own portal or electronic health record. CONCLUSIONS: Next steps will include continued recruitment of providers, addressing barriers to data transfer and integrating data from providers' portals into the registry to create a platform for future research.

Assessing the impact of jail-initiated medication for opioid use disorder: A multisite analysis of the SOMATICS collaborative.

The objective of this study was to estimate the associations of jail-initiated medication for opioid use disorder (MOUD) and patient navigation (PN) with opioid use disorder (OUD) at 6 months post-release. Three randomized trials (combined N = 330) were combined to assess whether MOUD (extended-release naltrexone or interim methadone) initiated prior to release from jail with or without PN would reduce the likelihood of a DSM-5 diagnosis of OUD 6 months post-release relative to enhanced treatment-as-usual (ETAU). Across the three studies, assignment to MOUD compared to ETAU was not associated with an OUD diagnosis at 6 months post-release (69% vs. 75%, respectively, OR = 0.67, 95% CI: 0.42 to 1.20). Similarly, PN compared to MOUD without PN was not associated with an OUD diagnosis (63% vs 77%, respectively, OR = 0.61, 95% CI: 0.27 to 1.53). Results underscore the need to further optimize the effectiveness of MOUD for patients initiating treatment in jail, beginning with an emphasis on post-release treatment adherence.

Hospital admissions among patients with Comorbid Substance Use disorders: a secondary analysis of predictors from the NavSTAR Trial.

BACKGROUND: Individuals with substance use disorders (SUDs) frequently use acute hospital services. The Navigation Services to Avoid Rehospitalization (NavSTAR) trial found that a patient navigation intervention for hospitalized patients with comorbid SUDs reduced subsequent inpatient admissions compared to treatment-as-usual (TAU). METHODS: This secondary analysis extends previous findings from the NavSTAR trial by examining whether selected patient characteristics independently predicted hospital service utilization and moderated the effect of the NavSTAR intervention. Participants were 400 medical/surgical hospital patients with comorbid SUDs. We analyzed 30- and 90-day inpatient readmissions (one or more readmissions) and cumulative incidence of inpatient admissions through 12 months using multivariable logistic and negative binomial regression, respectively. RESULTS: Consistent with primary findings and controlling for patient factors, NavSTAR participants were less likely than TAU participants to be readmitted within 30 (P = 0.001) and 90 (P = 0.03) days and had fewer total readmissions over 12 months (P = 0.008). Hospitalization in the previous year (P < 0.001) was associated with cumulative readmissions over 12 months, whereas Medicaid insurance (P = 0.03) and index diagnoses of infection (P = 0.001) and injuries, poisonings, or procedural complications (P = 0.004) were associated with fewer readmissions. None of the selected covariates moderated the effect of the NavSTAR intervention. CONCLUSIONS: Previous findings showed that patient navigation could reduce repeat hospital admissions among patients with comorbid SUDs. Several patient factors were independently associated with readmission. Future research should investigate risk factors for hospital readmission among patients with comorbid SUDs to optimize interventions. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT02599818, Registered November 9, 2015 https://classic. CLINICALTRIALS: gov/ct2/show/NCT02599818 .

Patient and provider medication preferences affect treatment outcomes among adolescents and young adults with opioid use disorder.

BACKGROUND: The opioid epidemic in the United States has not spared youth or young adults, as evidenced by a six-fold increase in opioid use disorder (OUD) diagnoses in the last two decades. Given this dramatic rise, a call for greater uptake and accessibility of medications for opioid use disorder (MOUDs) among youth and young adults has ensued, resulting in an increasing number of MOUD treatment pathways for this vulnerable population. METHODS: This secondary data analysis seeks to characterize patient and provider preferences for MOUD treatment pathways, and test for associations between baseline MOUD treatment preferences and opioid use and treatment adherence outcomes. Participants included 288 youth and young adults (age 15-21 years), recruited from a residential treatment program in Maryland. The study assessed patient preferences at baseline (n = 253) and provider preferences at patient treatment discharge (n = 224). Mixed-effects negative binomial regression models were conducted for opioid use outcomes, and logistic regressions were conducted for treatment adherence outcomes. RESULTS: Results indicate that congruence of treatment with patients' (Incidence Rate Ratio [IRR] = 0.65) and providers' (IRR = 0.66) preferences was significantly associated with reduced self-reported days of opioid use in the past 90 days, but only for patients receiving extended-release naltrexone (XR-NTX). Results also indicated that patients were less likely to switch medication treatment pathways (e.g., from XR-NTX to buprenorphine, or vice versa) during follow-up if they received their preferred treatment at baseline, a finding which held true for both XR-NTX (Odds Ratio [OR] = 0.32) and buprenorphine (OR = 0.22). CONCLUSIONS: Receipt of MOUD congruent with patient and provider preferences was associated with reduced opioid use and greater treatment adherence in this sample of youth and young adults with OUD.

Women and Treatment for Opioid Use Disorder: Contributors to Treatment Success From the Perspectives of Women in Recovery, Women With Past Attempts in Drug Treatment, and Health and Criminal Justice Professionals.

Introduction: The disproportionate incidence of opioid use disorder (OUD) and the alarming increases in opioid-related overdose deaths among women highlight a clear need for the expansion of effective harm reduction and treatment practices. Research supports medications for opioid use disorders (MOUD) as an effective intervention; however, with low rates of utilization of such, there is a need to identify factors that facilitate MOUD treatment uptake and retention for women. Thus, the current study examines contributors to treatment success through the triangulation of perspectives from affected women as well as health and criminal justice professionals. Methods: Interviews (N = 42) were conducted from May to July 2022 with women in recovery who previously used or currently use MOUD (N = 10), women who currently use opioids who terminated a MOUD program previously (N = 10), SUD treatment professionals (N = 12), and criminal justice professionals who work with women who use opioids (N = 10). Interviews for all participants centered around their backgrounds, perceived barriers and facilitators to MOUD treatment, and issues specific to women in treatment for substance use disorder. We used a thematic qualitative data analysis process to analyze transcripts. Results: Participants highlighted contributors to treatment success from 3 domains: (1) internal processes (including promoting self-efficacy and setting realistic goals), (2) access to resources (including material resources, such as food and shelter, educational resources and social support), and (3) treatment structure (such as treatment type and protocol). Conclusion: Internal processes, access to resources, and treatment structure contribute to MOUD treatment success for women with OUD. Structured support where experiences are shared, and realistic goals are set, may promote feelings of acceptance and empowerment, thereby bolstering chances of treatment success. Additionally, the court system can promote evidence-based and trauma-informed substance use treatment and provide accessible educational resources related to substance use to extend these benefits to more women.

Pregnancy- and parenting-related barriers to receiving medication for opioid use disorder: A multi-paneled qualitative study of women in treatment, women who terminated treatment, and the professionals who serve them.

BACKGROUND: Women face unique barriers when seeking treatment for substance use disorders, often related to pregnancy and parenting. OBJECTIVES: This study adds to the extant literature by elucidating the pregnancy- and parenting-related barriers women face when initiating or continuing medication for opioid use disorder, specifically. DESIGN: This study is based on qualitative semi-structured interviews. METHODS: Three subgroups participated in semi-structured interviews regarding their experiences (N = 42): women with current or past opioid use disorders who have used or were presently using medication for opioid use disorder, professionals working in substance use disorder treatment programs, and criminal justice professionals. RESULTS: Three parenting-related subthemes were identified: (1) insufficient access to childcare to navigate appointments and meetings, (2) fear of losing custody of, or access to, one's children, and (3) prioritizing one's children's needs before one's own. Three subthemes were identified with regard to pregnancy as a barrier: (1) hesitancy among physicians to prescribe medication for opioid use disorder for pregnant patients, (2) limited access to resources in rural areas, and (3) difficulty navigating a complex, decentralized health system. CONCLUSION: Systemic changes are needed to reduce pregnant and parenting women's barriers to seeking medication for opioid use disorder. These include improved childcare support at both in-patient and outpatient treatment programs, which would assuage women's barriers related to childcare, as well as their fears of losing access to their children if they spend time away from their children for treatment. An additional systemic improvement that may reduce barriers for these women is access to comprehensive, integrated care for their prenatal care, postpartum care, pediatric appointments, and appropriate substance use disorder treatment.

Pregnancy and parenting-related barriers to receiving medication for opioid use disorder: Interview themes from multiple perspectivesWomen face unique barriers when seeking treatment for substance use disorders, often related to pregnancy and parenting. This study used one-on-one interviews to learn more about the pregnancy- and parenting-related barriers women face when initiating or continuing medication for opioid use disorder, specifically. Three different groups were interviewed: women with current or past opioid use disorders who have used or were presently using medication for opioid use disorder, professionals working in substance use disorder treatment programs, and criminal justice professionals (N = 42). Three parenting-related themes emerged from the interviews: (1) insufficient access to childcare to navigate appointments and meetings, (2) fear of losing custody of, or access to, one's children, and (3) prioritizing one's children's needs before one's own. Three pregnancy-related themes emerged from the interviews: (1) hesitancy among physicians to prescribe medication for opioid use disorder for pregnant patients, (2) limited access to resources in rural areas, and (3) difficulty navigating a complex health system. Systemic changes are needed to reduce pregnant and parenting women's barriers to seeking medication for opioid use disorder. These include improved childcare support at treatment programs, which would assuage women's barriers related to childcare, as well as their fears of losing access to their children if they spend time away from their children for treatment. An additional systemic improvement that may reduce barriers for these women is access to comprehensive, integrated care for their prenatal care, postpartum care, pediatric appointments, and appropriate substance use disorder treatment.

Patient Engagement in and Adaptations to Delivery of Outpatient Care for Opioid Use Disorder During the COVID-19 Pandemic.

OBJECTIVE: The authors investigated adaptations to outpatient care delivery and changes in treatment demand and engagement among patients receiving medications for opioid use disorder (MOUD) in the months after the declaration of the COVID-19 public health emergency in 2020. METHODS: Data were collected through an online survey (June-November 2020) of outpatient MOUD prescribers. The survey obtained information on outpatient practices' adaptations to MOUD treatment and urine drug screening (UDS) and elicited provider views on the effects of the COVID-19 pandemic on patient demand for, and engagement in, treatment. Multivariable regression analyses were used to examine associations among practice characteristics, patient engagement, and service adaptations. RESULTS: Of 516 respondents, 74% reported adaptations to MOUD delivery during the pandemic. Most respondents implemented virtual visits for initial (67%) and follow-up (77%) contacts. Prescribers of buprenorphine were more likely than those who did not prescribe the medication to report MOUD adaptations. Among respondents reporting any MOUD adaptation, 77% made adaptations to their UDS practices. Among 513 respondents who answered COVID-19-related questions, 89% reported that the pandemic had affected the treatment and engagement of their patients. Of these respondents, 30% reported increased difficulty with patient engagement, and 45% reported that their patients preferred virtual visits during this period, whereas 18% endorsed patient preference for in-person visits. CONCLUSIONS: Telehealth and federal regulatory easements in response to the COVID-19 pandemic enabled providers to continue treating patients for opioid use disorder in 2020. The results suggest that care adaptations and changes in patient demand and engagement were common in the practices surveyed.

The Relationship between Vaping Cannabis and Frequency of Cannabis Use and Cannabis-Related Problems among Urban High School Students.

Background: Vaping, including vaping cannabis, is increasing among adolescents. In this longitudinal study, we examined the relationship between vaping cannabis and frequency of cannabis use and related problems over 6 months among adolescents. Material and Methods: Data were from 233 participants (46.8% male, 93.1% African American, mean age = 16.4 years) reporting cannabis use. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) assessed frequency of past 30-day cannabis use and cannabis-related problems at baseline, 3- and 6-months post-baseline. We used latent growth curve modeling to compare vaping to non-vaping adolescents on trends in cannabis use frequency and ASSIST cannabis scores. Results: Adolescents who vaped cannabis (11.7%) had higher past 30-day frequency (mean = 17.89 days, SD = 10.49) of cannabis use at baseline compared to adolescents who had not vaped (mean = 12.1 days, SD = 10.93), but reported a significantly sharper decline in frequency of cannabis use (b = -0.34, p = 0.017). A significantly steeper decrease existed in the mean cannabis ASSIST scores for the vaping group than for the non-vaping group (b = -0.34, p = 0.014). Mean ASSIST scores on the cannabis subscale between the two groups were significantly different at 6-month follow-up (Vape mean = 6.00, SD = 8.12 vs. Non-vape mean = 9.6, SD = 9.39; p < 0.021). Conclusions: In a sample of cannabis-using adolescents, adolescents with experience vaping cannabis, compared to adolescents without vaping experience, on average reported sharper decreases in frequency of cannabis use and cannabis-related problems such as health or social problems.

State guidance and system changes related to COVID-19: Impact on opioid treatment programs.

INTRODUCTION: In the United States, methadone treatment may only be provided through opioid treatment programs (OTPs), which operate under a complex system of federal and state regulations. During the pandemic, federal regulators relaxed several longstanding restrictions for OTPs by permitting expanded eligibility for take-home medication and allowing counseling and medication management through telehealth. The purpose of this study was to assess the guidance provided by states regarding the revised guidelines and efforts to protect staff and patients in response to the pandemic. METHODS: Between September and October of 2020, The National Association of State Alcohol and Drug Abuse Directors (NASADAD) and Friends Research Institute, fielded a web-based qualitative survey of state opioid treatment authorities (SOTAs) across the United States, the District of Columbia, and Puerto Rico. The study conducted the survey prior to the availability of the COVID vaccines. It queried 42 SOTAs concerning state guidance provided to OTPs on treatment operations and practices for existing patients and new admissions; actions to protect staff and patients; changes in treatment need and operational capacity; and administrative practices regarding treatment. This study examines the responses of 42 SOTAs (65 %) who completed the survey. RESULTS: Using content analysis, responses to the survey indicate that most states provided guidance to OTPs in response to the revised federal regulations and the need to protect staff and patients. All respondents reported that their states permitted increased number of take-homes doses for existing patients (100 %) and most reported doing so for new admissions (69 %; N=29). Ninety-eight percent (98 %; N=41) reported permitting remote counseling for existing patients and 90 % (N=38) permitting this for new admissions. SOTAs reported providing guidance on staff safety, operational procedures, oversight, and reforming billing practices to align with new models of service delivery. CONCLUSIONS: SOTAs generally reported that federal guidance increased patient access, engagement, and retention. Increased take-home flexibilities were viewed as important for expanding access and continuity of treatment, with the majority of SOTAs stating that the revised treatment practices (e.g., expansion of telehealth, flexible medication dispensing practices) were beneficial. These regulatory flexibilities, many believe, promoted the continuation of treatment and successful patient outcomes during the pandemic.

Opioid treatment program culture and philosophy: Views of OTP staff and state officials on implementing interim methadone treatment.

INTRODUCTION: People seeking treatment at opioid treatment programs (OTPs) can face admission delays. Interim methadone (IM) treatment, an effective approach to expedite admissions when programs lack sufficient counseling staff, has been seldom implemented. A study of implementation facilitation to spur the use of IM was conducted among six OTPs and their state opioid treatment authorities (SOTAs) in four US states. Between study recruitment and launch, organizational changes at three OTPs eliminated their need for IM. Two OTPs' requests to their states to provide IM (one prior to study launch and one following launch) were deferred by the states due to internal issues that required resolution to comply with federal IM regulations. During the study, another OTP's delays resolved, and one OTP streamlined its admissions procedures. METHODS: Virtual interviews were conducted with 16 OTP staff and SOTAs from six OTPs in four US states following their participation in the parent study. Interviews focused on the feasibility and acceptability of the implementation intervention for IM. We analyzed data using a constant comparative approach. RESULTS: Two overarching themes emerged from the qualitative data with respect to the role that organizational culture plays in OTP staff views of efforts to implement interim methadone: (1) the contrasting views of interim methadone based on whether staff adopt a traditional treatment vs. harm reduction philosophy and (2) the importance of reconciling these philosophies in addressing the culture shift that would accompany the process of implementing IM. CONCLUSIONS: Organizational treatment philosophy and program culture emerged as important factors determining the OTPs' staff's willingness to adopt new approaches to expedite admissions. Participants noted a tension between traditional treatment and harm reduction philosophies that impacted their views of IM, in part based on when they entered the drug treatment field. While understanding and addressing treatment philosophy and organizational culture and willingness to change is of importance when implementing new approaches in OTPs, leadership at the state and OTP level are powerful drivers of change.

Polysubstance use and post-discharge mortality risk among hospitalized patients with opioid use disorder.

Polysubstance use is becoming increasingly common and presents several harms. This study aimed to examine the association of comorbid cocaine, alcohol (binge drinking), and sedative use with mortality among hospitalized patients with opioid use disorder (OUD). A subsample of adult medical/surgical hospital patients with OUD who were seen by a hospital addiction consultation service in Baltimore City and enrolled in a randomized trial of a patient navigation intervention were included in this study (N = 314; 45 % female; 48 % White; mean age = 44). Death certificate data from the Maryland Division of Vital Records was used, covering 3.3-5.5 years post-discharge. Multivariable proportional hazards Cox regression and competing risks regression were used to estimate all-cause mortality and overdose mortality, respectively, as a function of concurrent use of cocaine, alcohol (binge drinking), and non-prescribed sedatives at baseline. In the 30 days prior to hospital admission, 230 (73 %) participants used cocaine, 64 (20 %) binge drank, and 45 (14 %) used non-prescribed sedatives. Nearly one-third (N = 98; 31 %) died during the observation period. Drug overdose caused 53 % (N = 52) of deaths. Older age (HR = 1.03 [1.01,1.05]; P = 0.001), less than high school education (HR = 0.36 [0.24,0.54]; P < 0.001), and past 30-day sedative use (HR = 2.05 [1.20,3.50]; P = 0.008) were significantly associated with all-cause mortality. The risk of overdose mortality was 62 % lower (HR = 0.38 [0.22,0.66]; P = 0.001) for those who completed high school. No other characteristics were significantly associated with overdose mortality. The concurrent use of opioids and sedatives increases the post-discharge mortality risk among hospitalized patients with OUD. Interventions are needed to prevent mortality among this high-risk population.

The Spanish language version of the TAPS tool: protocol for a validation and implementation study in primary care.

BACKGROUND: The TAPS Tool ("Tobacco, Alcohol, Prescription drug, and illicit Substance use") is a screening and brief assessment for detecting unhealthy substance use in healthcare settings that was developed by the National Institute on Drug Abuse Clinical Trials Network and validated in a multisite study. Our team developed a Spanish language version of the TAPS Tool that supports provider- and self-administration screening using a mobile/web-based platform, the TAPS Electronic Spanish Platform (TAPS-ESP). METHODS: This article describes the protocol and rationale for a study to validate the TAPS-ESP in a sample of Spanish-speaking primary care patients recruited from a network of community-based clinics in Texas (target N = 1,000). The TAPS-ESP will be validated against established substance use disorder diagnostic measures, alternative screening tools, and substance use biomarkers. The study will subsequently examine barriers and facilitators to screening with the TAPS-ESP from a provider workflow perspective using qualitative interviews with providers. DISCUSSION: Validating a Spanish language version of the TAPS Tool could expand access to evidence-based, linguistically accurate, and culturally relevant substance use screening and brief assessment for an underserved health disparity population. TRIAL REGISTRATION: The study was registered with www. CLINICALTRIALS: gov : NCT05476588, 07/22/2022.

Impact of COVID-19-related methadone regulatory flexibilities: views of state opioid treatment authorities and program staff.

BACKGROUND: During the COVID-19 pandemic, federal regulations in the USA for methadone treatment of opioid use disorder (OUD) were temporarily revised to reduce clinic crowding and promote access to treatment. METHODS: As part of a study seeking to implement interim methadone without routine counseling to hasten treatment access in Opioid Treatment Programs with admission delays, semi-structured qualitative interviews were conducted via Zoom with participating staff (N = 11) in six OTPs and their State Opioid Treatment Authorities (SOTAs; N = 5) responsible for overseeing the OTPs' federal regulatory compliance. Participants discussed their views on the response of OTPs in their states to the pandemic and the impact of the COVID-related regulatory flexibilities on staff, established patients, and new program applicants. Interviews were audio recorded, transcribed, and a content analysis was conducted using ATLAS.ti. RESULTS: All SOTAs requested the blanket take-home exemption and supported the use of telehealth for counseling. Participants noted that these changes were more beneficial for established patients than program applicants. Established patients were able to obtain a greater number of take-homes and attend individual counseling remotely. Patients with limited resources had greater difficulty or were unable to access remote counseling. The convenience of intake through telehealth did not extend to new program applicants because the admission physical exam requirement was not waived. CONCLUSIONS: The experienced reflections of SOTAs and OTP providers on methadone practice changes during the COVID-19 pandemic offer insights on SAMHSA's proposed revisions to its OTP regulations. Trial registration Clinicaltrials.gov # NCT04188977.

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.

Comparing outcomes of extended-release naltrexone in adolescents and young adults with opioid use disorder.

INTRODUCTION: Opioid use among youth is a public health concern in the United States, with >3300 overdose deaths occurring nationally each year. Unfortunately, youth in the United States are still prescribed medication for opioid use disorder (OUD) at a lower rate than their adult counterparts. METHODS: From 10/2013 to 01/2018, adolescents (ages 15-17; n = 25) and young adults (ages 18-21; n = 263) with moderate to severe OUD enrolled in the parent trial of extended-release naltrexone (XR-NTX; n = 82) versus treatment-as-usual (TAU; either buprenorphine maintenance [n = 94] or counseling without buprenorphine maintenance [n = 112]). The study assessed opioid use outcomes for adolescents vs. young adults using timeline follow-back self-report procedures at baseline and 3-/6-month follow-up assessments. Mixed-effects longitudinal and clustered panel regression models compared treatment effects over time of XR-NTX and TAU on opioid use outcomes in this secondary analysis. RESULTS: Though adolescent participants reported significantly less opioid use at baseline relative to their young adult counterparts (p < 0.05), the two age groups reported similar rates of opioid use throughout the intervention period. Additionally, both adolescents and young adults receiving XR-NTX evidenced lower rates of opioid use than those receiving TAU at all time points, and adolescents on XR-NTX were the only group who reduced their opioid use at all time points. Mixed-effects models indicated adolescents receiving XR-NTX demonstrated a 48 % lower rate of opioid use days [Incidence Rate Ratio (IRR) = 0.52; p = 0.020], while young adults receiving XR-NTX reported an estimated 26 % lower rate (IRR = 0.74; p = 0.009). CONCLUSIONS: Results indicate that adolescents respond favorably to XR-NTX relative to TAU for treatment of OUD, demonstrating similar outcomes to young adults.

Pharmacy-based methadone treatment in the US: views of pharmacists and opioid treatment program staff.

BACKGROUND: The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD. METHODS: Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data. RESULTS: Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients' cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists. CONCLUSION: This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.

A Brief Screening and Assessment Tool for Opioid Use in Adults: Results from a Validation Study of the Tobacco, Alcohol, Prescription Medication, and Other Substances Tool.

OBJECTIVES: This secondary analysis evaluated opioid-specific validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substances (TAPS) tool for screening in primary care. METHODS: This study is a secondary data analysis of the TAPS validation study. Performance of the TAPS tool for screening for unhealthy opioid use (with a score of 1+ for heroin and/or prescription opioids representing a positive screen) was evaluated. Discriminative ability was examined in comparison with reference standard measures across the spectrum of unhealthy opioid use: timeline follow-back with and without oral fluid testing identifying past-month use and the modified Composite International Diagnostic Interview for past-year problem use, opioid use disorder (OUD), and moderate-severe OUD. RESULTS: In a sample of 2000 primary care patients, 114 screened positive for opioids on the TAPS tool. With a TAPS cutoff equal to 1+, the TAPS accurately identified past-month use, problem use, any OUD, and moderate-severe OUD (sensitivities = 68%-85%, specificities = 97%-98%, area under the curve = 0.80-0.91). When past-month use was expanded to include timeline follow-back with oral fluid testing, accuracy declined (52% sensitivity [95% confidence interval, 43%-60%], 98% specific [95% confidence interval, 97%-98%]). CONCLUSIONS: While further testing in a larger population sample may be warranted, given their brevity, simplicity, and accuracy when self-administered, the TAPS opioid items can be used in primary care settings for a spectrum of unhealthy opioid use; however, self-disclosure remains an issue in primary care settings.

Patient perspectives on community pharmacy administered and dispensing of methadone treatment for opioid use disorder: a qualitative study in the U.S.

BACKGROUND: Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients' perspectives on PADMOUD. Data are timely and needed to inform the implementation of PADMOUD in the US to address its serious opioid overdose crisis. METHODS: Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes. RESULTS: Seventeen participants completed the interview. Patients' perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists' training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD. CONCLUSION: This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients' views and needs.