Comparative effectiveness of extended-release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients.

BACKGROUND AND AIMS: Extended-release naltrexone (XR-NTX) and sublingual buprenorphine (SL-BUP) are both approved for opioid use disorder (OUD) treatment in any medical setting. We aimed to compare the real-world effectiveness of XR-NTX and SL-BUP. DESIGN AND SETTING: This was an observational active comparator, new user cohort study of Medicaid claims records for patients in New Jersey and California, USA, 2016-19. PARTICIPANTS/CASES: The participants were adult Medicaid patients aged 18-64 years who initiated XR-NTX or SL-BUP for maintenance treatment of OUD and did not use medications for OUD in the 90 days before initiation. Our cohort included 1755 XR-NTX and 9886 SL-BUP patients. MEASUREMENTS: We examined two outcomes up to 180 days after medication initiation: (1) composite of medication discontinuation and death and (2) composite of overdose and death. FINDINGS: In adjusted analyses, treatment with XR-NTX was more likely to result in discontinuation or death by the end of follow-up than treatment with SL-BUP: cumulative risk 75.9% [95% confidence interval (CI) = 73.9%, 77.9%] versus 62.2% (95% CI = 61.2%, 63.2%), respectively (risk difference = 13.7 percentage points, 95% CI = 11.4, 16.0). There was minimal difference in the cumulative risk of overdose or death by the end of follow-up: XR-NTX 3.9% (95% CI = 3.0%, 4.8%) versus SL-BUP 3.3% (95% CI = 2.9%, 3.7%); risk difference = 0.5 percentage points, 95% CI = -0.4, 1.5. Results were consistent across sensitivity analyses. CONCLUSIONS: Medicaid patients in California and New Jersey, USA, receiving treatment for opioid use disorder stayed in treatment longer on sublingual buprenorphine than on extended-release naltrexone, but the risk of overdose was similar. Most patients in this study discontinued medication within 6 months, regardless of which medication was initiated.

The impact of chronic pain and depression on medication for opioid use disorder treatment: A mixed-methods analysis.

Background: Opioid use disorder (OUD) is associated with significant morbidity and mortality. Medication for opioid use disorder (MOUD) is a cost-effective treatment, but retention rates vary widely. Aim: Mixed methods studies are needed to better understand how depression and pain impact the experience of OUD and MOUD treatment experiences. Methods: Participants were recruited from an urban addiction treatment center in the United States. Along with demographic characteristics, current pain severity, pain interference, pain catastrophizing, and depression were assessed via self-report. Correlational analyses, multivariable logistic regression models, Fisher exact tests, and Wilcoxon signed rank tests were used to examine the impact of demographic characteristics, physical pain, and depression on multiple treatment outcomes: 90-day treatment engagement (total number of dispensed MOUD doses), retention (yes/no still in treatment at 90 days), and opioid use (positive/negative urinalysis for opioids at 90 days). Ten participants were interviewed about their history with physical pain, depression, opioid use, and OUD treatment experiences. Themes were identified using a rapid analysis, top-down approach. Results: Fifty participants enrolled in the study and received buprenorphine (12%) or methadone (88%). Older age was associated with 90-day treatment engagement. Higher depression scores were associated with a positive opioid urinalysis at 90-day follow-up. In interviews, participants reported experiencing chronic physical pain and depression before and during their OUD and an interest in addressing mental and physical health in addiction treatment. Conclusions: Addressing co-occurring physical and mental health concerns during MOUD treatment has the potential to improve the treatment experience and abstinence from opioids.

The impact of emergency guidance to the COVID-19 pandemic on treatment entry, retention and mortality among patients on methadone in Ukraine.

BACKGROUND AND AIMS: Ukraine's Ministry of Health released urgent COVID-19 guidelines, allowing for early implementation of take-home dosing (THD) for opioid agonist therapies (OAT) such as methadone. Enrollment in OAT and retention in the program are the most effective HIV prevention strategies for people who inject drugs (PWID). This study aimed to evaluate the impact of Ukraine's COVID-19 emergency guidance on OAT treatment enrollment, retention on treatment and mortality. DESIGN AND SETTING: Using Ukraine's national OAT registry for 252 governmental clinics across 25 regions, we conducted a 12-month comparative prospective cohort survival analysis. This study compared newly enrolled methadone patients within the initial 6 months following the COVID-19 guidance (COVID) with patients from the preceding year (pre-COVID) in a country with high adult HIV prevalence (1.2%) that is concentrated in PWID. PARTICIPANTS: In the nation-wide sample of newly enrolled PWID in Ukraine, comprising 2798 individuals, 1423 were in the COVID cohort and 1375 were in the pre-COVID cohort. The majority were male (86.7%), with an average age of 39.3 years. MEASUREMENTS: Primary outcomes were average monthly enrollment per cohort, treatment retention and mortality, with internal time-dependent predictors, including THD and optimal (> 85 mg) methadone dosing. RESULTS: Relative to the pre-COVID period, the monthly average patient enrollment was statistically significantly higher during the COVID period (283.7 versus 236.0; P < 0.0001), where patients were more likely to transition to THD and achieve optimal dosing earlier. Significant differences were observed in the proportions of person-months on THD (41 versus 13%, P < 0.0001) and optimal dosing (38 versus 31%, P < 0.0001) between the COVID and pre-COVID cohorts. Predictors of treatment retention, expressed as adjusted hazard ratios (aHR), included early THD [aHR = 1.90, 95% confidence interval (CI) = 1.47-2.45], early optimal dosing (aHR = 1.71, 95% CI = 1.37-2.13) and prior methadone treatment (aHR = 1.39, 95% CI = 1.15-1.68). These factors persisted, respectively, in the pre-COVID (aHR = 2.28, 95% CI = 1.41-3.70; aHR = 1.84, 95% CI = 1.32-2.56; and aHR = 1.36, 95% CI = 1.06-1.74) and COVID (aHR = 1.91, 95% CI = 1.40-2.59; aHR = 1.61, 95% CI = 1.20-2.16; and aHR = 1.49, 95% CI = 1.08-1.94) cohorts. Survival did not differ significantly between the two prospective cohorts. CONCLUSION: Ukraine's prompt adoption of early take-home dosing for opioid agonist therapies, such as methadone, following the emergency COVID-19 guidance appears to have increased enrollment into methadone and improved treatment retention for people who inject drugs without adverse effects on patient survival.

Early identification of golimumab-treated patients with higher likelihood of long-term retention.

Background: The early identification of patients' profiles most likely to respond to and maintain long-term therapy with a biological drug can have clinical and cost-effectiveness implications. Objectives: To evaluate the utility of an innovative approach for early identification of patient profiles associated with long-term persistence of golimumab, a tumour necrosis factor inhibitor, in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (SpA) under real-world conditions. Design: Retrospective non-interventional database analysis. Methods: Kaplan-Meier curves of golimumab retention over 8 years from the BIOBADASER registry, overall and by indication, were analysed using a novel approach (a two-phase decay model) to identify the point at which the golimumab retention curve shifted from rapid (indicating high golimumab discontinuation rate) to slow decay (low discontinuation rate). Factors associated with golimumab retention at these time points were identified using Cox regression, and retention rates for different patient profiles were calculated. Results: 885 patients were included. The golimumab retention curve shifted from rapid to slow decay at month 10 for the overall population (retention rate: 73.4%), at month 24 for RA patients (retention: 45.0%), and at month 8 for SpA, including axial SpA and PsA (81.6%). Factors associated with golimumab discontinuation at these early points were, overall, similar to those previously identified at year 8 (RA diagnosis, golimumab as second- or third-line of biological therapy, disease activity over the median and treatment with corticosteroids at golimumab initiation, advanced age [in RA], and female gender [in SpA]). Conclusion: With this novel approach, the factors associated with long-term retention were identified in the initial period of rapid discontinuation of golimumab.

Impulsivity Dimensions Predict Treatment Dropout Among Women in Residential Treatment for Substance Use Disorders.

Residential treatment for substance use disorders (SUDs) is effective at reducing substance use, dependence, and other related problems. However, dropout from treatment against medical advice (AMA) is common in residential treatment settings. Studies have shown that impulsivity is associated with substance misuse and treatment dropout in predominately male samples, but less is known regarding whether impulsivity dimensions predict treatment dropout among women. This study examined impulsivity dimensions (ie, negative urgency, positive urgency, lack of perseverance, lack of premeditation, and sensation seeking) as predictors of dropout AMA among women in a residential substance use treatment facility (N = 229). Logistic regression results demonstrated that elevations in lack of perseverance and sensation seeking were associated with an increased odds of treatment dropout AMA and that lack of premeditation was associated with a decreased odds of treatment dropout AMA. Study findings suggest that early evidence-based interventions for sensation seeking and lack of perseverance may improve retention of women in residential treatment.

Protocol for harmonization of randomized trials testing the addition of behavioral therapy to buprenorphine for opioid use disorder.

Background: Although buprenorphine is an effective treatment for opioid use disorder (OUD), much remains to be understood about treatment non-response and methods for improving treatment retention. The addition of behavioral therapies to buprenorphine has not yielded consistent benefits for opioid outcomes, on average. However, several studies suggest that certain subgroups may benefit from the combination of buprenorphine and behavioral therapy, highlighting the potential for personalized approaches to treatment. Furthermore, little is known about whether behavioral therapies improve buprenorphine retention or non-opioid (e.g., functional) outcomes. Methods: The objective of this project is to harmonize four previously conducted clinical trials testing the addition of behavioral therapy to buprenorphine maintenance for OUD and to use this larger dataset to answer critical clinical questions about the role of behavioral therapy in this population. Study aims include identifying potential moderators of the effect of the addition of behavioral therapy and quantifying the effect of behavioral therapy on buprenorphine retention and functional outcomes. Results: Analyses will consider outcomes of weeks of opioid use, weeks of retention in buprenorphine treatment, and functional outcomes as measured by the Addiction Severity Index. Analyses will include an indicator for each study to account for heterogeneity of samples and design. Conclusion: Results will help to inform clinical and research efforts to optimize the use of behavioral therapies in the treatment of 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.

Nine-year substance use treatment outcomes with buprenorphine for opioid use disorder in a federally qualified health center.

BACKGROUND: Prescribing medication for opioid use disorder (MOUD) in primary care helps meet treatment demand, but few studies examine long-term treatment retention among medically-underserved primary care patients. METHODS: This 9-year retrospective study assessed overall retention at 6 months, and yearly up to 9 years, among 1451 patients with at least 6 months of buprenorphine prescription data from a federally-qualified health center (FQHC). We also examined whether patients who had gaps in treatment (>14 days without medication) later returned to care. Associations with treatment retention over total time in care were assessed. RESULTS: On average, patients received buprenorphine treatment for 2.26 years. Among patients who experienced gaps in treatment but returned to care within 90 days, 64% were still receiving buprenorphine at six months (n=930 of 1451), and 70% (n =118 of 169) at 9 years, with an average yearly interval retention of 69% (range: 58-74%). Patients were on MOUD treatment and not in a gap about 81% of the time, and averaged 1.0 gap per patient per year (SD: 1.09; range 0-7.87). The mean gap length over the treatment period was 33.16 days. Older age, higher percentages of negative opioid tests, negative cocaine tests, and positive buprenorphine tests, and having diabetes were associated with longer treatment retention. CONCLUSIONS: Opioid use disorder (OUD) can be treated successfully in primary care FQHCs. Treatment gaps are common and reflect the chronic relapsing nature of OUD.

Opioid-induced hypogonadism in opioid use disorder, its role in negative reinforcement, and implications for treatment and retention.

Hypogonadism is a highly prevalent complication of chronic opioid use associated with a constellation of affective, algesic, and cognitive symptoms as well as decreased quality of life. Given that the mainstays of pharmacologic opioid use disorder (OUD) treatment - methadone and buprenorphine - are themselves agonists or partial agonists at the mu opioid receptor, opioid-induced hypogonadism (OIH) remains an underappreciated clinical concern throughout the course of OUD treatment. Prominent theoretical frameworks for OUD emphasize the importance of negative reinforcement and hyperkatifeia, defined as the heightened salience of negative emotional and motivational states brought on by chronic opioid use. In this perspective article, we highlight the striking parallels between the symptom domains of hyperfakifeia and hypogonadism in males, who comprise the vast majority of existing clinical research on OIH. By extension we propose that future research and ultimately clinical care should focus on the identification and treatment of OIH in OUD patients to help address the longstanding paradox of poor treatment retention despite efficacious therapies, particularly in the setting of the current opioid overdose epidemic driven by high potency synthetic opioids such as fentanyl. We then review evidence from chronic pain patients that testosterone replacement provides clinically significant benefits to men with OIH. Finally, using this framework, we compare extant OUD therapeutics and discuss critical gaps in the clinical literature-including the relative dearth of data regarding hypothalamic-pituitary-gonadal function in females who use opioids-where future study should be focused.

Barriers to retention in medications for opioid use disorder treatment in real-world practice.

BACKGROUND: Medications for Opioid Use Disorder (MOUD) are an effective method to treat persons with opioid use disorder (OUD). Longer treatment times are associated with better health outcomes, yet treatment retention rates remain low. This study aimed to assess patient characteristics and experiences associated with retention in treatment. METHODS: Data were from an observational cohort study of OUD treatments. Among persons receiving buprenorphine or methadone, log-binomial regression models assessed the relationship between patient characteristics and experiences and three retention outcomes: retention in any OUD treatment, retention in the index treatment (OUD treatment being administered at the time when patients were screened for study eligibility), and 6-month retention in the index treatment. RESULTS: Individuals being treated with methadone at the start of the study compared to those treated with buprenorphine were more likely to remain in their same index treatment at the 18-month follow-up (aPR = 1.35; 95 % CI = 1.11-1.65), and to have remained on their index treatment for 6-months or longer (aPR = 1.22; 95 % CI = 1.14-1.32), but were not significantly more likely to remain in any OUD treatment overall. Individuals residing five miles or less from treatment were more likely to have been retained in any OUD treatment (aPR = 1.06; 95 % CI = 1.00-1.12), to remain in their index treatment at the 18-month follow-up (aPR = 1.21; 95 % CI = 1.08-1.36), and to have remained in their index treatment for 6 months or more (aPR = 1.08; 95 % CI = 1.02-1.13). Individuals without health insurance were less likely to be retained in any OUD treatment (aPR = 0.86; 95 % CI = 0.78-0.95). CONCLUSION: The prevalence of retention in any OUD treatment was higher for individuals residing five miles or less from treatment. These findings expand on previous studies that have shown distance to and location of treatment sites can impact treatment access and retention. Lack of health insurance was also associated with lower retention in any OUD treatment in this study. Given the high burden associated with overdose deaths, it is important to understand and address barriers to retention in treatment.

Trauma-focused therapy retention among military sexual trauma survivors: relationship with veterans' sexual or gender minority identification.

Military servicemembers identifying as sexual and gender minorities (SGM) are at increased risk for military sexual trauma (MST) exposure and Post-traumatic Stress Disorder (PTSD). Although evidence-based treatments can reduce symptoms of PTSD, treatment attrition is concerning. Unfortunately, evaluations of such approaches with veterans identifying as SGM are currently restricted to case studies offering limited information regarding treatment completion. Both historic and current contextual factors related to military and mental health practices may uniquely influence minority veterans' treatment engagement in veteran healthcare settings. We explored associations between SGM identification and treatment of MST-focused therapy completion patterns (finishing the full protocol [FP] or receiving minimally adequate care [MAC; defined as attending eight or more sessions]). Veterans (N = 271, 12.5% SGM) enrolled in individual Prolonged Exposure or Cognitive Processing Therapies at a Midwestern veterans hospital system. Those identifying as SGM were more likely than non-identifying peers to complete FP treatment and, even when attrition occurred, they were retained longer. For MAC, the SGM group was as likely as non-SGM peers to be retained. This research suggests SGM veterans represent a notable minority of those seeking treatment in association with MST and do not appear at greater risk for discontinuation from trauma-focused treatment.

Comparative effectiveness of extended release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients.

Aims: To compare the real-world effectiveness of extended release naltrexone (XR-NTX) and sublingual buprenorphine (SL-BUP) for the treatment of opioid use disorder (OUD). Design: An observational active comparator, new user cohort study. Setting: Medicaid claims records for patients in New Jersey and California, 2016-2019. Participants/Cases: Adult Medicaid patients aged 18-64 years who initiated XR-NTX or SL-BUP for maintenance treatment of OUD and did not use medications for OUD in the 90-days before initiation. Comparators: New initiation with XR-NTX versus SL-BUP for the treatment of OUD. Measurements: We examined two outcomes up to 180 days after medication initiation, 1) composite of medication discontinuation and death, and 2) composite of overdose and death. Findings: Our cohort included 1,755 XR-NTX and 9,886 SL-BUP patients. In adjusted analyses, treatment with XR-NTX was more likely to result in discontinuation or death by the end of follow-up than treatment with SL-BUP: cumulative risk 76% (95% confidence interval [CI] 75%, 78%) versus 62% (95% CI 61%, 63%), respectively (risk difference 14 percentage points, 95% CI 13, 16). There was minimal difference in the cumulative risk of overdose or death by the end of follow-up: XR-NTX 3.8% (95% CI 2.9%, 4.7%) versus SL-BUP 3.3% (95% 2.9%, 3.7%); risk difference 0.5 percentage points, 95%CI -0.5, 1.5. Results were consistent across sensitivity analyses. Conclusions: Longer medication retention is important because risks of negative outcomes are elevated after discontinuation. Our results support selection of SL-BUP over XR-NTX. However, most patients discontinued medication by 6 months indicating that more effective tools are needed to improve medication retention, particularly after initiation with XR-NTX, and to identify which patients do best on which medication.

Identifying the Heterogeneity in the Association between Workforce Diversity and Retention in Opioid Treatment among Black clients.

Background: This study investigates the impact of workforce diversity, specifically staff identified as Black/African American, on retention in opioid use disorder (OUD) treatment, aiming to enhance patient outcomes. Employing a novel machine learning technique known as 'causal forest,' we explore heterogeneous treatment effects on retention. Methods: We relied on four waves of the National Drug Abuse Treatment System Survey (NDATSS), a nationally representative longitudinal dataset of treatment programs. We analyzed OUD program data from the years 2000, 2005, 2014 and 2017 (n = 627). Employing the 'causal forest' method, we analyzed the heterogeneity in the relationship between workforce diversity and retention in OUD treatment. Interviews with program directors and clinical supervisors provided the data for this study. Results: The results reveal diversity-related variations in the association with retention across 61 out of 627 OUD treatment programs (less than 10%). These programs, associated with positive impacts of workforce diversity, were more likely private-for-profit, newer, had lower percentages of Black and Latino clients, lower staff-to-client ratios, higher proportions of staff with graduate degrees, and lower percentages of unemployed clients. Conclusions: While workforce diversity is crucial, our findings underscore that it alone is insufficient for improving retention in addiction health services research. Programs with characteristics typically linked to positive outcomes are better positioned to maximize the benefits of a diverse workforce in client retention. This research has implications for policy and program design, guiding decisions on resource allocation and workforce diversity to enhance retention rates among Black clients with OUDs.

Rapid Initiation of Antiretroviral Therapy With Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Versus Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate in HIV-Positive Men Who Have Sex With Men in China: Week 48 Results of the Multicenter, Randomized Clinical Trial.

BACKGROUND: Most international treatment guidelines recommend rapid initiation of antiretroviral therapy (ART) for people newly diagnosed with human immunodeficiency virus (HIV)-1 infection, but experiences with rapid ART initiation remain limited in China. We aimed to evaluate the efficacy and safety of efavirenz (400 mg) plus lamivudine and tenofovir disoproxil fumarate (EFV + 3TC + TDF) versus coformulated bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) in rapid ART initiation among men who have sex with men (MSM) who have been diagnosed with HIV. METHODS: This multicenter, open-label, randomized clinical trial enrolled MSM aged ≥18 years to start ART within 14 days of confirmed HIV diagnosis. The participants were randomly assigned in a 1:1 ratio to receive EFV (400 mg) + 3TC + TDF or BIC/FTC/TAF. The primary end point was viral suppression (<50 copies/mL) at 48 weeks per US Food and Drug Administration Snapshot analysis. RESULTS: Between March 2021 and July 2022, 300 participants were enrolled; 154 were assigned to receive EFV + 3TC + TDF (EFV group) and 146 BIC/FTC/TAF (BIC group). At week 48, 118 (79.2%) and 140 (95.9%) participants in the EFV and BIC group, respectively, were retained in care with viral suppression, and 24 (16.1%) and 1 (0.7%) participant in the EFV and BIC group (P < .001), respectively, discontinued treatment because of adverse effects, death, or lost to follow-up. The median increase of CD4 count was 181 and 223 cells/µL (P = .020), respectively, for the EFV and BIC group, at week 48. The overall incidence of adverse effects was significantly higher for the EFV group (65.8% vs 37.7%, P < .001). CONCLUSIONS: BIC/FTC/TAF was more efficacious and safer than EFV (400 mg) + 3TC + TDF for rapid ART initiation among HIV-positive MSM in China.

"I'm on the Right Path": Exploring 1-Month Retention in a Homeless-Tailored Outpatient-Based Opioid Treatment Program.

BACKGROUND: Homeless-tailored office-based opioid treatment (OBOT) programs have been developed to address the ongoing opioid overdose crisis, which disproportionately affects people experiencing homelessness. The objective of this study was to evaluate the facilitators of and barriers to retention in a homeless-tailored OBOT program. METHODS: We performed in-depth qualitative interviews with 24 homeless-experienced adults who newly enrolled in Boston Health Care for the Homeless Program's OBOT program from January 6, 2022 through January 5, 2023. We purposively sampled participants based on whether they were retained at 1 month (n = 12) or not (n = 12). We used an abductive analytic process, applying codes to the interview transcripts from an a priori analytic framework based on the Behavioral Model for Vulnerable Populations and supplementing with emergent codes as needed. We compared themes by participants' 1-month retention status to explore facilitators of and barriers to retention in OBOT care. RESULTS: The average age was 41.9 years, 29.2% were female, 20.8% were Black, 58.3% were White, and 33.0% were Hispanic. Facilitators of retention common to many participants included the clinic experience, low-threshold model, clinic staff, and provision of comprehensive care. Among participants who were retained at 1-month, personal motivation, use of extended-release buprenorphine, and adequate buprenorphine efficacy were additional facilitators. Barriers to retention common to many participants included the clinic's surrounding environment, competing subsistence difficulties, and transportation difficulty. Among participants who were not retained at 1-month, opioid use severity, drug use in social networks, and inadequate buprenorphine efficacy represented additional barriers. CONCLUSIONS: We identified several common determinants of OBOT retention among our homeless-experienced participants as well as some facilitators and barriers that differed by 1-month retention status. These divergent factors represent potential points of intervention to promote retention in homeless-tailored OBOT programs.

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

BACKGROUND AND AIMS: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). DESIGN: This study was a pilot single-blinded multi-site randomized trial. SETTING: Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated. PARTICIPANTS: One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n = 53) or UC (n = 49). INTERVENTION: PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. MEASUREMENTS: Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6 months postpartum. FINDINGS: We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥ 75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2 months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) = 9.7, 62.1] and some evidence for baseline to 6 months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN = 7.4 versus UC = -21.3, 95% CI = 3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2 months (PN = 11.9%/UC = 16.1%) and at 6 months postpartum (PN = 3.8%/UC = 6.2%). CONCLUSIONS: Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.

Evaluation of opioid use disorder treatment outcomes in patients receiving split daily versus once daily dosing of buprenorphine-naloxone.

INTRODUCTION: In clinical practice, sublingual (SL) buprenorphine-naloxone is prescribed as once daily or split daily dosing for the management of opioid use disorder (OUD). Evidence is lacking that assesses how split daily buprenorphine-naloxone affects OUD outcomes. This study aims to evaluate how the dosing frequency of SL buprenorphine-naloxone impacts therapy effectiveness when treating patients with OUD. METHODS: This retrospective analysis included adult outpatients prescribed treatment with SL buprenorphine-naloxone for OUD between July 1, 2016, and March 1, 2020. The study excluded patients with sickle cell disease, recent methadone treatment, or pregnancy. We characterized study groups by dosing frequency, either once daily or split dosing. The study compared retention in treatment, medication adherence, adherence to treatment program, and hospital encounters between groups. RESULTS: The study screened eight-hundred and seven patients, and included 250 patients newly prescribed SL buprenorphine-naloxone. Fifty-seven patients (22.8 %) were prescribed once daily dosing and 193 patients (77.2 %) were prescribed split daily dosing. The study found no significant differences noted in 12-month rates of treatment retention (52.6 % vs. 45.6 %, p = .35). These outcomes remained similar when assessed at three and six months. Within a year of buprenorphine-naloxone initiation, the study found no differences in the percentage of patients with hospitalizations (26.3 % vs. 38.3 %, p = .10), median number of hospitalizations (2 vs. 2), or proportion of days covered by a prescription ≥80 % (93.3 % vs. 92.0 %, p = .82). CONCLUSIONS: In this study, patients receiving once daily buprenorphine-naloxone had similar treatment outcomes to patients receiving split dosing. Further controlled studies are necessary to evaluate which patients are more likely to benefit from split dosing.

Co-occurring psychiatric disorders and disparities in buprenorphine utilization in opioid use disorder: An analysis of insurance claims.

Background: As the overdose crisis continues in the U.S. and Canada, opioid use disorder (OUD) treatment outcomes for people with co-occurring psychiatric disorders are not well characterized. Our objective was to examine the influence of co-occurring psychiatric disorders on buprenorphine initiation and discontinuation. Methods: This retrospective cohort study used multi-state administrative claims data in the U.S. to evaluate rates of buprenorphine initiation (relative to psychosocial treatment without medication) in a cohort of 236,198 people with OUD entering treatment, both with and without co-occurring psychiatric disorders, grouping by psychiatric disorder subtype (mood, psychotic, and anxiety-and-related disorders). Among people initiating buprenorphine, we assessed the influence of co-occurring psychiatric disorders on buprenorphine retention. We used multivariable Poisson regression to estimate buprenorphine initiation and Cox regression to estimate time to discontinuation, adjusting for all 3 classes of co-occurring disorders simultaneously and adjusting for baseline demographic and clinical characteristics. Results: Buprenorphine initiation occurred in 29.3 % of those with co-occurring anxiety-and-related disorders, compared to 25.9 % and 17.5 % in people with mood and psychotic disorders. Mood (adjusted-risk-ratio[aRR] = 0.82[95 % CI = 0.82-0.83]) and psychotic disorders (aRR = 0.95[0.94-0.96]) were associated with decreased initiation (versus psychosocial treatment), in contrast to greater initiation in the anxiety disorders cohort (aRR = 1.06[1.05-1.06]). We observed an increase in buprenorphine discontinuation associated with mood (adjusted-hazard-ratio[aHR] = 1.20[1.17-1.24]) and anxiety disorders (aHR = 1.12[1.09-1.14]), in contrast to no association between psychotic disorders and buprenorphine discontinuation. Conclusions: We observed underutilization of buprenorphine among people with co-occurring mood and psychotic disorders, as well as high buprenorphine discontinuation across anxiety, mood, and psychotic disorders.

Transgender individuals are at higher risk for suicidal ideation and preparation than cisgender individuals in substance use treatment.

Introduction: This study describes the differences and similarities in mental health, substance use, and substance use treatment outcomes between people presenting for SUD treatment who identified as transgender and those who identified as cisgender men or women. Methods: We compared 64 individuals who self-identified as transgender and presented for SUD treatment to samples of cisgender men and women (separately) matched based on propensity scores which were created based on sociodemographic factors known to influence both the nature of substance use and patterns of treatment engagement including age, education, race, stable housing, and employment status. Comparisons were made using χ2 tests and t-tests in over 150 variables collected at treatment intake regarding physical and mental health, substance use patterns, events that led to treatment, reasons for seeking treatment, and treatment outcomes. Results: The transgender sample endorsed six of the seven suicide-related items more often than at least one of the cisgender-matched samples. Furthermore, the transgender sample remained in treatment significantly longer (M = 32.3, SD = 22.2) than the cisgender male sample (M = 19.5, SD = 26.1, t = 2.17, p = 0.03). Discussion: This study is a first step into understanding gender minority population experiences during SUD treatment. While there was no significant difference between the cisgender and transgender samples on most variables, there was an elevated prevalence of suicidal ideation and behaviors in the transgender sample, which warrants further investigation.

Trends in buprenorphine dosage and days supplied for new treatment episodes for opioid use disorder, 2010-2019.

BACKGROUND: Buprenorphine reduces risk of opioid overdose mortality. However, its benefits are limited by low retention, particularly in early treatment. Optimizing initial dosage may impact retention. However, little is known about the prescription characteristics of new buprenorphine treatment episodes. METHODS: In a US sample of commercial and employer-sponsored pharmacy claims, we identified new buprenorphine treatment episodes (days 1-30) from individuals ≥16 years following 90 days without buprenorphine from 2010 to 2019. Outcomes included first prescription average days supplied, first prescription average daily dosage, and average dosage on days 2, 8, 15 and 30. RESULTS: We identified 117,793 new episodes among 96,451 unique individuals. Episodes per 10,000 person-years decreased slightly over time. Stratifying by age, sex and region demonstrated decreasing episodes among individuals ≤34 years and increasing episodes among individuals ≥35 years. From 2010-2019, first prescription average days supplied and daily dosage decreased from 17.1 to 15.3 days and 13.6mg to 11.6mg, respectively. Simultaneously, the proportion of episodes without possession and with dosages <16mg increased across all days and years. By day 30, episodes without buprenorphine possession grew from 27.9% to 30.8% and episodes involving dosages of <16mg grew from 26.4% to 33.4%. CONCLUSIONS: We found that buprenorphine dosage and days supplied for new treatment episodes decreased from 2010 to 2019 while buprenorphine possession worsened. Further investigation examining the relationship between buprenorphine dosage and retention in the early treatment period is needed.