Engaging the Great Circle: a qualitative study of the Confederated Tribes of Grand Ronde's mobile medication unit

BACKGROUND: The Confederated Tribes of the Grand Ronde Community of Oregon began a Mobile Medication Unit (MMU) as part of their Great Circle Recovery Opioid Treatment Program (OTP) to address elevated rates of opioid use disorder (OUD) among American Indians and Alaska Natives in Oregon. The MMU provides methadone or buprenorphine for individuals with OUD, enrolled in the OTP, who are living either on the reservation or in surrounding rural communities. An implementation study describes the service through document review and qualitatively assesses patient and staff experiences and the perceived barriers and facilitators to mobile services. METHODS: Semi-structured qualitative interviews with patients (n = 11), MMU staff (n = 5), and the state opioid treatment authority (n = 1) gathered details on the initiative's development and operations. Provider interviews probed implementation experiences. Patient interviews focused on their experiences with the MMU and staff, changes in quality of life and recommendations for enhancing treatment. Interviews were transcribed and analysed using a Thematic Analysis approach. RESULTS: Staff themes identified two driving forces (i.e. staff desire for an inclusive approach to wellness that is accessible to all community members; the catalysts for the MMU), two steps toward MMU development (i.e. Tribal approvals and support; the construction and maintenance of community relationships) and two perspectives on MMU implementation and impact (i.e. initial implementation barriers; facilitators and observations of how the MMU reduced stigma associated with agonist therapy). Patients' themes noted the MMU's professional and 'caring' environment, accessible rural locations and general suggestions including culturally responsive ancillary services. CONCLUSION: The Great Circle MMU enhanced access to opioid agonist therapy for people with OUD (i.e. American Indians/Alaska Natives, and non-natives) living in rural communities. The Confederated Tribes of Grand Ronde operates the first Tribally owned OTP MMU, grounded in cultural humility and committed to Tribal members and the great circle of the larger community.

Usability and feasibility of a take-home methadone web-application for opioid treatment program patients: A Small Business Innovation Research mixed methods study.

BACKGROUND: Most patients in opioid treatment programs (OTPs) attend daily for observed dosing. A Stage IA (create and adapt) and a Stage IB (feasibility and pilot) mixed method studies tested a web-application (app) designed to facilitate access to take-home methadone. METHODS: A Stage IA, intervention development study, used qualitative interviews to assess the usability (ease of use) and feasibility (ability to implement) of a take-home methadone app. The Stage IA market research was a two-week test with 96 patient participants from four OTPs. Qualitative interviews were completed with 20 systematically selected individuals who used the take-home app and 20 OTP clinicians (five each from the four OTPs). The Stage IB Small Business Innovation Research (SBIR) study (24 patients and 8 clinicians in a single OTP) included quantitative assessments of the app's usability, acceptability, appropriateness, and feasibility. Thematic analysis coded participant and staff assessments of the take-home app. RESULTS: Stage IA patients (mean age = 41 years; 52 % men, 57 % White) and IB patients (mean age = 38 years, 54 % men, 79 % White) described the app as "easy to use." Compared to unsupervised take-homes, some patients preferred using the take-home app. In Stage IB, patients rated the app highly on standardized measures of usability, acceptability, appropriateness, and feasibility. Clinician ratings were more ambivalent. Patients rated in-clinic dosing as more disruptive than unsupervised take-homes and take-homes using the app. DISCUSSION: A Stage IA study informed the development and maturation of a Stage IB feasibility pilot study. Overall, the take-home app's usability, acceptability, appropriateness, and feasibility were rated positively. Clinical staff ratings were less positive, but individuals commented that using the app a) enhanced patient quality of life, b) provided new tools for counselors, and c) offered competitive advantages. The SBIR award enhanced market research with more complete and systematic data collection and analysis.

Addiction severity and re-employment in Sweden among adults with risky alcohol and drug use.

BACKGROUND: The Addiction Severity Index (ASI) assesses respondents' biopsychosocial problems in seven addiction-related domains (mental health, family and social relations, employment, alcohol use, drug use, physical health, and legal problems). This study examined the association between the seven ASI composite scores and re-employment in a sample of Swedish adults screened for risky alcohol and drug use who were without employment at assessment. METHODS: We conducted a retrospective cohort analysis of employment outcomes among 6502 unemployed adults living in Sweden who completed an ASI assessment for risky alcohol and drug use. The study linked ASI scores to annual tax register data. The primary outcome was employment, defined as having earnings above an administrative threshold. We used Cox proportional hazard models to estimate the association between time to re-employment and ASI composite scores, controlling for demographic characteristics, RESULTS: Approximately three in ten individuals in the sample regained employment within five years. ASI composite scores suggested widespread biopsychosocial problems. Re-employment was associated with lower ASI composite scores for mental health (estimate: 0.775, 95 % confidence interval: 0.629-0.956), employment (estimate: 0.669, confidence interval: 0.532-0.841), drug use (estimate: 0.628, confidence interval: 0.428-0.924), and health (estimate: 0.798, confidence interval: 0.699-0.912). CONCLUSIONS: This study suggests that several ASI domains may provide information on the complex factors (i.e., mental health, health, drug use) associated with long-term unemployment for people with risky substance use.

Prescription Opioid Dose Reductions and Potential Adverse Events: a Multi-site Observational Cohort Study in Diverse US Health Systems.

BACKGROUND: In response to the opioid crisis in the United States, population-level prescribing of opioids has been decreasing; there are concerns, however, that dose reductions are related to potential adverse events. OBJECTIVE: Examine associations between opioid dose reductions and risk of 1-month potential adverse events (emergency department (ED) visits, opioid overdose, benzodiazepine prescription fill, all-cause mortality). DESIGN: This observational cohort study used electronic health record and claims data from eight United States health systems in a prescription opioid registry (Clinical Trials Network-0084). All opioid fills (excluding buprenorphine) between 1/1/2012 and 12/31/2018 were used to identify baseline periods with mean morphine milligram equivalents daily dose of  ≥ 50 during six consecutive months. PATIENTS: We identified 60,040 non-cancer patients with  ≥ one 2-month dose reduction period (600,234 unique dose reduction periods). MAIN MEASURES: Analyses examined associations between dose reduction levels (1- < 15%, 15- < 30%, 30- < 100%, 100% over 2 months) and potential adverse events in the month following a dose reduction using logistic regression analysis, adjusting for patient characteristics. KEY RESULTS: Overall, dose reduction periods involved mean reductions of 18.7%. Compared to reductions of 1- < 15%, dose reductions of 30- < 100% were associated with higher odds of ED visits (OR 1.14, 95% CI 1.10, 1.17), opioid overdose (OR 1.41, 95% CI 1.09-1.81), and all-cause mortality (OR 1.39, 95% CI 1.16-1.67), but lower odds of a benzodiazepine fill (OR 0.83, 95% CI 0.81-0.85). Dose reductions of 15- < 30%, compared to 1- < 15%, were associated with higher odds of ED visits (OR 1.08, 95% CI 1.05-1.11) and lower odds of a benzodiazepine fill (OR 0.93, 95% CI 0.92-0.95), but were not associated with opioid overdose and all-cause mortality. CONCLUSIONS: Larger reductions for patients on opioid therapy may raise risk of potential adverse events in the month after reduction and should be carefully monitored.

State- and County-Level Geographic Variation in Opioid Use Disorder, Medication Treatment, and Opioid-Related Overdose Among Medicaid Enrollees.

Importance: The opioid crisis disproportionately affects Medicaid enrollees, yet little systematic evidence exists regarding how prevalence of and health care utilization for opioid use disorder (OUD) vary across geographical areas. Objectives: To characterize state- and county-level variation in claims-based prevalence of OUD and rates of medication treatment for OUD and OUD-related nonfatal overdose among Medicaid enrollees. Design, Setting, and Participants: This cross-sectional study used data from the Transformed Medicaid Statistical Information System Analytic Files from January 1, 2016, to December 31, 2018. Participants were Medicaid enrollees with or without OUD in 46 states; Washington, DC; and Puerto Rico who were aged 18 to 64 years and not dually enrolled in Medicare. The analysis was conducted between September 2022 and April 2023. Exposure: Calendar-year OUD prevalence. Main Outcomes and Measures: The main outcomes were claims-based measures of OUD prevalence and rates of medication treatment for OUD and opioid-related nonfatal overdose. Individual records were aggregated at the state and county level, and variation was assessed within and across states. Results: Of the 76 390 817 Medicaid enrollee-year observations included in our study (mean [SD] enrollee age, 36.5 [1.6] years; 59.0% female), 2 280 272 (3.0%) had a claims-based OUD (mean [SD] age, 38.9 [3.6] years; 51.4% female). Of enrollees with OUD, 41.2% were eligible due to Medicaid expansion, 46.4% had other substance use disorders, 55.8% had mental health conditions, 55.2% had claims indicating some form of OUD medication, and 5.8% had claims indicating an overdose during a calendar year. Claims-based outcomes exhibited substantial variation across states: OUD prevalence ranged from 0.6% in Arkansas and Puerto Rico to 9.7% in Maryland, rates of OUD medication treatment ranged from 17.7% in Kansas to 82.8% in Maine, and rates of overdose ranged from 0.3% in Mississippi to 10.5% in Illinois. Pronounced variation was also found within states (eg, OUD prevalence in Maryland ranged from 2.2% in Prince George's County to 21.6% in Cecil County). Conclusions and Relevance: In this cross-sectional study of Medicaid enrollees from 2016 to 2018, claims-based prevalence of OUD and rates of OUD medication treatment and opioid-related overdose varied substantially across and within states. Further research appears to be needed to identify important factors influencing this variation.

Recruitment challenges for a prospective telehealth cohort study.

Background: The COVID-19 pandemic presents challenges in participant recruitment strategies for clinical research involving people with opioid use disorders recently engaged in treatment. We describe challenges to participant recruitment in a trial comparing virtual buprenorphine treatment platform to office-based buprenorphine treatment. Methods: The parent study was a cohort trial of telehealth delivered buprenorphine treatment compared to office-based buprenorphine treatment, however, due to the pandemic potential participant recruitment for both arms became virtual. Between 9/27/2021 and 7/11/2022, telephone, email, flyers, and word-of-mouth were used to recruit study participants from each treatment setting. Recruitment tracking documents recorded the primary outcomes: number of outreach attempts and most effective contact methods. Results: Treatment settings provided contact information for 1485 potential study participants. Information was incorrect or disconnected for 282 (19%) individuals, 695 (47%) did not respond to outreach, and 508 (34%) responded to outreach. Of these responders, 369 were interested in study participation, 259 completed the online informed consent and screening assessment, and 148 met eligibility criteria and enrolled in the study. A total of 3804 virtual outreach attempts across 1485 potential participants were made, resulting in an average of 2.7 attempts per contact and a mean of 25.7 attempts per enrolled participant (n = 148). Conclusion: Conducting research during the COVID-19 pandemic required shifting from in-person to virtual recruitment strategies to contact and engage potential study participants. Virtual recruitment for this population during a pandemic appears to be less efficient and hindered efforts to meet recruitment goals.

Association between treatment setting and outcomes among oregon medicaid patients with opioid use disorder: a retrospective cohort study.

BACKGROUND: Residential treatment is a common approach for treating opioid use disorder (OUD), however, few studies have directly compared it to outpatient treatment. The objective of this study was to compare OUD outcomes among individuals receiving residential and outpatient treatment. METHODS: A retrospective cohort study used linked data from a state Medicaid program, vital statistics, and the Substance Abuse and Mental Health Services Administration (SAMHSA) Treatment Episodes Dataset (TEDS) to compare OUD-related health outcomes among individuals treated in a residential or outpatient setting between 2014 and 2017. Multivariable Cox proportional hazards and logistic regression models examined the association between treatment setting and outcomes (i.e., opioid overdose, non-overdose opioid-related and all-cause emergency department (ED) visits, hospital admissions, and treatment retention) controlling for patient characteristics, co-morbidities, and use of medications for opioid use disorders (MOUD). Interaction models evaluated how MOUD use modified associations between treatment setting and outcomes. RESULTS: Of 3293 individuals treated for OUD, 957 (29%) received treatment in a residential facility. MOUD use was higher among those treated as an outpatient (43%) compared to residential (19%). The risk of opioid overdose (aHR 1.39; 95% CI 0.73-2.64) or an opioid-related emergency department encounter or admission (aHR 1.02; 95% CI 0.80-1.29) did not differ between treatment settings. Independent of setting, MOUD use was associated with a significant reduction in overdose risk (aHR 0.45; 95% CI 0.23-0.89). Residential care was associated with greater odds of retention at 6-months (aOR 1.71; 95% CI 1.32-2.21) but not 1-year. Residential treatment was only associated with improved retention for individuals not receiving MOUD (6-month aOR 2.05; 95% CI 1.56-2.71) with no benefit observed in those who received MOUD (aOR 0.75; 95% CI 0.46-1.29; interaction p = 0.001). CONCLUSIONS: Relative to outpatient treatment, residential treatment was not associated with reductions in opioid overdose or opioid-related ED encounters/hospitalizations. Regardless of setting, MOUD use was associated with a significant reduction in opioid overdose risk.

Differences in the delivery of medications for opioid use disorder during hospitalization by racial categories: A retrospective cohort analysis.

Background: As the drug-related overdose crisis and COVID-19 pandemic continue, communities need increased access to medications for opioid use disorder (MOUD) (i.e., buprenorphine and methadone). Disparities in the type of MOUD prescribed or administered by racial and ethnic categories are well described in the outpatient clinical environment. It is unknown, however, if these disparities persist when MOUD is provided in acute care hospitals. Methods: This study assessed differences in the delivery of buprenorphine versus methadone during acute medical or surgical hospitalizations for veterans with opioid use disorder (OUD) by racial categories (Black Non-Hispanic or Latino vs. White Non-Hispanic or Latino). Data were obtained retrospectively from the Veterans Health Administration (VHA) for federal fiscal year 2017. We built logistic regression models, adjusted for individual and hospital-related covariates, and calculated the predicted probabilities of MOUD delivery by racial categories. Results: The study cohort (n = 1,313 unique patients; N = 107 VHA hospitals) had a mean age of 57 (range 23 to 87 years), was predominantly male (96%), and composed entirely of Black (29%) or White (71%) patients. White patients were 11% more likely than Black patients to receive buprenorphine than methadone during hospitalization (p = 0.010; 95% CI: 2.7%, 20.0%). Among patients on MOUD prior to hospitalization, White patients were 21% more likely than Black patients to receive buprenorphine (p = 0.000; 95% CI: 9.8%, 31.5%). Among patients newly initiated on MOUD during hospitalization, there were no differences by racial categories. Conclusion: We observed disparities in the delivery of buprenorphine versus methadone during hospitalization by racial categories. The observed differences in hospital-based MOUD delivery may be influenced by MOUD received prior to hospitalization within the racialized outpatient addiction treatment system. The VHA and health systems more broadly must address all aspects of racism that contribute to inequitable MOUD access throughout all clinical contexts.

Development and implementation of a prescription opioid registry across diverse health systems.

Objective: Develop and implement a prescription opioid registry in 10 diverse health systems across the US and describe trends in prescribed opioids between 2012 and 2018. Materials and Methods: Using electronic health record and claims data, we identified patients who had an outpatient fill for any prescription opioid, and/or an opioid use disorder diagnosis, between January 1, 2012 and December 31, 2018. The registry contains distributed files of prescription opioids, benzodiazepines and other select medications, opioid antagonists, clinical diagnoses, procedures, health services utilization, and health plan membership. Rates of outpatient opioid fills over the study period, standardized to health system demographic distributions, are described by age, gender, and race/ethnicity among members without cancer. Results: The registry includes 6 249 710 patients and over 40 million outpatient opioid fills. For the combined registry population, opioid fills declined from a high of 0.718 per member-year in 2013 to 0.478 in 2018, and morphine milligram equivalents (MMEs) per fill declined from 985 MMEs per fill in 2012 to 758 MMEs in 2018. MMEs per member declined from 692 MMEs per member in 2012 to 362 MMEs per member in 2018. Conclusion: This study established a population-based opioid registry across 10 diverse health systems that can be used to address questions related to opioid use. Initial analyses showed large reductions in overall opioid use per member among the combined health systems. The registry will be used in future studies to answer a broad range of other critical public health issues relating to prescription opioid use.

Hospital Admission Rate, Cumulative Hospitalized Days, and Time to Admission Among Older Persons With Substance Use and Psychiatric Conditions.

Background: Substance use among older persons occurs with medical and psychiatric comorbidities. This study examined the associations of substance use disorder (SUD), psychiatric, and dual diagnoses with 12-month cumulative hospitalized days, hospital admission rate and number of days to first hospitalization. Methods: The cohort of 3,624 individuals (28.2% women) aged 50 years or older was assessed for substance use severity in 65 Swedish municipalities during March 2003-May 2017. Addiction Severity Index data were linked to hospital discharge records and crime statistics. The outcomes were (a) 12-month cumulative hospitalized days; (b) Hospital admission rate, and (c) days to first hospitalization. Generalized linear regression techniques investigated associations between outcomes and SUD, psychiatric and dual diagnoses at admission. Results: During 2003-2017, 73.5% of the participants were hospitalized. Twelve-month hospitalized days were positively associated with SUD (Incidence rate ratio (IRR) = 1.41, 95%CI: 1.26-1.58), dual diagnosis (IRR = 2.03, 95%CI: 1.74-2.36), and psychiatric diagnoses (IRR = 2.51, 95%CI: 2.09-3.01). Hospital admission rate was positively associated with SUD (IRR = 4.67, 95%CI: 4.28-5.08), dual diagnosis (IRR = 1.83, 95%CI: 1.64-2.04), and psychiatric diagnoses (IRR = 1.73, 95%CI: 1.55-1.92). Days to first hospitalization were negatively associated with SUD (IRR = 0.52, 95%CI: 0.47-0.58), dual diagnosis (IRR = 0.57, 95%CI: 0.50-0.65), and psychiatric diagnoses (IRR = 0.83, 95%CI: 0.73-0.93). The marginal effects of SUD and/or mental disorders increased with age for all outcomes, except for days to first hospitalization. Conclusion: Three of four older persons assessed for substance use severity were later hospitalized. Substance use disorders, dual diagnoses and other mental disorders were the primary reasons for hospitalization and were associated with longer stays, earlier hospitalization, and repeated admissions. Sensitizing service providers to old age substance use and sharing data across the care continuum could provide multiple points of contact to reduce the risk of hospitalizations among older persons with problematic substance use.

Treatment retention, return to use, and recovery support following COVID-19 relaxation of methadone take-home dosing in two rural opioid treatment programs: A mixed methods analysis.

OBJECTIVES: In March 2020, the Substance Abuse and Mental Health Services Administration permitted Opioid Treatment Programs (OTPs) to relax restrictions on take-home methadone and promoted telehealth to minimize potential exposures to COVID-19. We assessed the effects of COVID-19-related changes on take-home methadone dosing in two OTPs serving five rural Oregon counties. METHODS: We used a mixed-methods convergent design. The OTPs extracted urine drug test (UDT) results, take-home methadone regimens, and treatment retention from the electronic health record (EHR) for patients (n = 377). A mixed-effects negative binomial regression model assessed patient-level differences in take-home doses before and after the COVID-19 policy changes and the associations with treatment discontinuation, and UDT positivity. Semi-structured qualitative interviews (n = 32) explored patient reactions to increased take-home dosing and reduced clinic visits to provide context for quantitative findings. RESULTS: The number of take-home doses increased in the post-COVID-19 period for patients engaged in treatment for more than 180 days (median: 8 vs 13 take-home doses per month, p = 0.011). Take-homes did not increase for patients with fewer days of treatment. Each percentage point increase in take-home dosing above what would be expected without COVID-19 policy changes was negatively associated with the percent of UDT positive for opioids (B = -0.12, CI [-0.21, -0.04], p = 0.005) and the probability of treatment discontinuation (aOR = 0.97, CI [0.95, 0.99], p = 0.003). Qualitative analysis revealed three themes explaining how increased take-home dosing supported recovery: 1) value of feeling trusted with increased responsibility; 2) reduced travel time permitted increased employment and recreation; and 3) reduced exposure to individuals less stable in recovery and potential triggers. CONCLUSIONS: Take-home methadone dose relaxations were associated with increased methadone take-home doses, improved retention, and decreased UDT opioid positive results among clinically stable patients. Qualitative findings suggest that fewer take-home restrictions are feasible and desirable and do not pose safety or public health harms.

Recurrent risk of hospitalization among older people with problematic alcohol use: a multiple failure-time analysis with a discontinuous risk model.

BACKGROUND AND AIMS: Older people with problematic alcohol use vary in psychosocial functioning, age of onset for problem drinking and use of other drugs. The study measured the differential risks of all-cause, alcohol-, polydrug- and psychiatric-related repeated hospitalizations among older people with problematic alcohol use. DESIGN: A linked register-based cohort study with discontinuous multiple-failure (time-to-repeated-event) data. Hospitalization and mortality were considered as failure. SETTING: Sweden, March 2003-November 2017, using data from the Addiction Severity Index (ASI) register linked to National Inpatient Register and the Swedish cause of death register. PARTICIPANTS: Participants aged 50 years and older (n = 1741; 28.2% women), with one or more alcohol problem days in the 30 days before an ASI assessment. MEASUREMENTS: Five mutually exclusive latent classes of problematic alcohol use, identified with 11 ASI items, were the independent variables: 'late onset with fewer consequences (LO:FC; reference group)'; 'early onset/prevalent multi-dimensional problems (EO:MD)'; 'late onset with co-occurring anxiety and depression (LO:AD)'; 'early onset with co-occurring psychiatric problems (EO:PP)'; and 'early onset with major alcohol problem (EO:AP)'. Covariates included socio-demographic characteristics, previous hospitalization and Elixhauser comorbidity index. Outcome measurements included recurrent hospitalization and/or mortality due to: (a) all-cause, (b) alcohol-related disorders and diseases (c) polydrug use and (d) other psychiatric disorders. FINDINGS: During the study period, more than 75% were hospitalized at least once or died. 57.3% were hospitalized with alcohol-related, 8.5% with polydrug use and 18.5% with psychiatric-related diagnoses. Compared with LO:FC, EO:PP had higher risk for all-cause [adjusted hazard ratio (aHR) = 1.27, 95% confidence interval (CI) = 1.02-1.59] and alcohol-related (aHR = 1.34, 95% CI = 1.02-1.75) hospitalizations. Adjusted risks for polydrug-related hospitalization were 2.55, 95% CI = 1.04-6.27 for EO:MD and 2.62, 95% CI = 1.07-6.40 for EO:PP. Adjusted risk for psychiatric-related hospitalization was higher for LO:AD (aHR = 1.78, 95% CI = 1.16-2.73 and EO:PP (aHR = 2.03, 95% CI = 1.22-3.38). CONCLUSIONS: Older addiction service users in Sweden have varying risks of hospitalization due to alcohol use, polydrug use and psychiatric disorders. Older people with problematic alcohol use who have multiple needs and are assessed in social services may benefit from earlier interventions with an integrated focus on substance use and mental health.

Expanding Inpatient Addiction Consult Services Through Accountable Care Organizations for Medicaid Enrollees: A Modeling Study.

INTRODUCTION: Addiction consult services (ACS) care for hospitalized patients with substance use disorder, including opioid use disorder (OUD). Medicaid Accountable Care Organizations (ACOs) could enhance access to ACS. This study extends data from Oregon's only ACS to Oregon's 15 regional Medicaid Coordinated Care Organizations (CCOs) to illustrate the potential value of enhanced in- and out-patient care for hospitalized patients with OUD. The study objectives were to estimate the effects of (1) expanding ACS care through CCOs in Oregon, and (2) increasing community treatment access within CCOs, on post-discharge OUD treatment engagement. METHODS: We used a validated Markov model, populated with Oregon Medicaid data from April 2015 to December 2017, to estimate study objectives. RESULTS: Oregon Medicaid patients hospitalized with OUD with care billed to a CCO (n = 5878) included 1298 (22.1%) patients engaged in post-discharge OUD treatment. Simulation of referral to an ACS increased post-discharge OUD treatment engagement to 47.0% (95% confidence interval [CI] 45.7%, 48.3%), or 2684 patients (95% CI 2610, 2758). Ten of fifteen (66.7%) CCOs had fewer than 20% of patients engage in post-discharge OUD care. Without ACS, increasing outpatient treatment such that 20% of patients engage increased the patients engaging in post-discharge OUD care from 12.9% or 296 patients in care at baseline to 20% (95% CI 18.1%, 21.4%) or 453 (95% CI 416, 491). DISCUSSION: ACOs can improve care for patients hospitalized with OUD. Implementing ACS in ACO networks can potentially improve post-discharge OUD treatment engagement, but community treatment systems must be prepared to accept more patients as inpatient addiction care improves.

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

BACKGROUND AND AIM: Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results. DESIGN: Open-label, non-inferiority randomized trial. SETTING: Six US HIV primary care clinics. PARTICIPANTS: A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. INTERVENTION: HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). MEASUREMENTS: Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks. FINDINGS: Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2). CONCLUSIONS: A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.

Recommendations to Inform Substance Use Disorder Data Sharing Research: Scoping Review and Thematic Analysis.

OBJECTIVES: Title 42 Code of Federal Regulations Part 2 (42 CFR Part 2 or Part 2) was enacted in 1975 to protect patients receiving treatment for substance use disorders. A scoping review on Part 2 characterized published work. METHODS: Seven databases were searched. Studies were categorized based on date of publication, primary objectives, methods, and findings. A thematic analysis was conducted using article titles and abstracts. RESULTS: Of the 36 studies identified, the majority (78%) were opinions or legal reviews, (22%) employed quantitative and/or qualitative methods to study the impact of Part 2, and over half (58%) were published in the past 5 years. Only 8% of studies reported stakeholder involvement in Part 2 studies and no study included patients or patient advocates. No study discussed the efforts to align Part 2 with Health Insurance Portability and Accountability Act or provided evidence of the benefit of this alignment. Three main themes emerged from the review: care delivery (46.6%), law and ethics (27.6%), and technology (25.9%). There were no studies focusing on stigma and its effect on substance use treatment and Part 2. CONCLUSIONS: Despite the significance of Part 2, the literature is sparse. It is time to initiate a new era of scholarly research that focuses on the impact of statutes and policies that govern substance use disorder data sharing. Specifically, we recommend research on Part 2 and Health Insurance Portability and Accountability Act alignment, the effects of Part 2 on patients, as well as providers and other stakeholder perceptions on the regulation.

Effectiveness of and Access to Medications for Opioid Use Disorder for Adolescents and Young Adults: A Scoping Review.

OBJECTIVE: A scoping review assessed access to medications for opioid use disorder (MOUD) and treatment outcomes among adolescents (12 - 17 years) and young adults (18 - 25 years). METHODS: Studies addressing adolescent and young adult opioid use disorder and treatment with MOUD on patient outcomes (eg, retention in care) were included. Randomized trials and controlled observational studies were prioritized. Investigators extracted key information, summarized findings, noted methodological weaknesses, and tabled the details. RESULTS: The search identified 4 randomized trials (N = 241), 1 systematic review with 52 studies (total N = 125,994), and 5 retrospective analyses of health insurance claims. The trials reported buprenorphine and extended-release naltrexone reduced opioid use. Return to use was observed when pharmacotherapy ceased. A systematic review concluded that adolescents and young adults had lower retention in care than older adults. The observational studies found that adolescents were unlikely to receive MOUD. There was some evidence that non-Hispanic Black adolescents and young adults were less likely than non-Hispanic Whites to receive MOUD. CONCLUSIONS: MOUD therapies reduce opioid use among adolescent and young adults but few receive MOUD. MOUD services for adolescents and young adults should be developed and tested. Randomized clinical trials are necessary to develop appropriate clinical guidelines for using MOUD with adolescents and young adults.

Frequency and recency of non-medical opioid use and death due to overdose or suicide among individuals assessed for risky substance use: A national registry study in Sweden.

Sweden and many other countries have experienced increases in suicide and accidental overdose deaths. An analysis examined the associations between recency of non-medical opioid misuse and frequency of use of non-medical opioids with death due to either suicide or accidental overdose within a sample of 15,000 Swedish adults who completed an Addiction Severity Index (ASI) assessment for risky substance use or a substance use disorder. METHODS AND MATERIALS: Suicide (n = 136) and death due to overdose (n = 405) were identified in the official Cause of Death Registry from the Swedish National Board of Health and Welfare. Control variables included demographic characteristics and risks associated with either overdose or suicide. Cox regression analyses controlled for variables statistically significantly at the bivariate level. RESULTS: At the multivariable level: a) a higher (modified) ASI Composite Score for mental health; b) history of suicide attempt; c) having used non-medical opioids for 1-2 times per week for at least a year; d) history of injection drug use; and, e) early onset of drug use, were all significantly and positively associated with death due to suicide. At the multivariable level: a) a higher the revised ASI Composite Score for mental health; b) recency of use of non-medical opioids; c) frequency of non-medical opioid use; d) being a male; and e) being of ages 18-24 years compared to ages 43-51 years were all positively and significantly associated with death due to accidental overdose. CONCLUSION: These findings underscore the need to integrate mental health and substance use disorder treatment and provide suicide and overdose prevention interventions for individuals with an opioid use disorder. Recency and frequency of non-medical opioids were only associated with death due to overdose and not suicide. However, other drug use related variables (using opioids 1-2 times per week for at least a year, early onset of drug use and drug injection) were significantly associated with death due to suicide.

Opioid treatment programs, telemedicine and COVID-19: A scoping review.

Background: Methadone and buprenorphine are effective medications for opioid use disorder (MOUD) that are highly regulated in the United States. The on-going opioid crisis, and more recently COVID-19, has prompted reconsideration of these restrictions in order to sustain and improve treatment access, with renewed interest in telemedicine. We reviewed the evidence on use of telemedicine interventions and applicability to MOUD policy changes in the post-COVID-19 treatment landscape. Methods: Ovid MEDLINE and the Cochrane Database of Systematic Reviews databases were searched from inception to April 2021 and reference lists were reviewed to identify additional studies. Studies were eligible if they examined telemedicine interventions and reported outcomes (e.g. treatment initiation, retention in care). Randomized trials and controlled observational studies were prioritized; other studies were included when stronger evidence was unavailable. One investigator abstracted key information and a second investigator verified data. We described the results qualitatively. Results: We identified nine studies: three controlled trials (two randomized), and six observational studies. Three studies evaluated patients treated with methadone and six studies with buprenorphine, including one study of pregnant women with OUD. All studies showed telemedicine approaches associated with similar outcomes (treatment retention, positive urine toxicology) compared to treatment as usual. Trials were limited by small samples sizes, lack of reporting harms, and most were conducted prior to the COVID-19 pandemic; observational studies were limited by failure to control for confounding. Conclusions: Limited evidence suggests that telemedicine may enhance access to MOUD with similar effectiveness compared with face-to-face treatment. Few studies have been published since COVID-19, and it is unclear the potential impact of these interventions on the existing racial/ethnic disparities in treatment. The COVID-19 pandemic and need for social distancing led to temporary policy changes for prescribing of MOUD that could inform additional research in this area to support comprehensive policy reforms.