Feasibility and acceptability of a novel digital therapeutic combining behavioral and pharmacological treatment for opioid use disorder.

Objective: Despite the worsening of the opioid epidemic, access to quality treatment for opioid use disorder (OUD) including buprenorphine remains a challenge. With the onset of the COVID-19 public health emergency, temporary regulatory changes and expanded reimbursement for telehealth services allowed for the rapid expansion of remote treatment for OUD and increased access to buprenorphine, but limited research exists to support this revolutionary shift in care delivery. This study evaluates the feasibility and acceptability of a novel digital therapeutic intervention for OUD combining buprenorphine and behavioral therapy. Methods: Adults (n = 27) with OUD received treatment with daily sublingual buprenorphine and psychosocial treatment delivered digitally via a smartphone app over 12 weeks. Participants were evaluated monthly for continued opioid use, medication adherence, anxiety and depression indicators, abstinence self-efficacy, craving, and overall well-being, as well as a one-time measure of treatment acceptability. Results: Participants reported increased opioid abstinence days from baseline (M = 8.2, SD = 8.6) to 12 weeks per 30 days (M = 24.9, SD = 10.1), t(20) = -6.5, p < .000, with strong medication adherence across study waves (96.2%). Anxiety and depression indicators, and opioid craving significantly decreased, and abstinence self-efficacy and overall well-being significantly increased following the intervention. Participants also demonstrated high rates of treatment engagement. Conclusions: As current public health emergency regulatory changes are reviewed for permanency, this feasibility and acceptability study of a novel digital therapeutic intervention for OUD including buprenorphine adds to the growing evidence that supports maintaining telehealth access for quality OUD treatment.

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.

Implementing Suicide Risk Screening in a Virtual Addiction Clinic.

The purpose of this study was to describe the feasibility of implementing suicide risk screening in a virtual addiction clinic. Suicide risk screening was implemented in a virtual addiction clinic serving individuals with substance use disorders (SUD) using a quality improvement framework. One-hundred percent (252/252) of eligible patients enrolled in the clinic were screened for suicide risk (44% female; M[SD] age = 45.0[11.0] years, range = 21-68 years). Nineteen patients (8%) screened positive for suicide risk. After screening, no patients required emergency suicide interventions (100% non-acute positive). Notably, 74% (14/19) of those who screened positive did so by endorsing at least one past suicide attempt with no recent ideation. Suicide risk screening in virtual addiction clinics yields important clinical information for high-risk SUD populations without overburdening workflow with emergency services. Given the high proportion of non-acute positive screens based on suicide attempt histories with no recent ideation, clinicians may utilize information on suicide attempt history to facilitate further mental healthcare.

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.

Health care use and cost of treatment for adolescents and young adults with opioid use disorder.

BACKGROUND: Few studies have examined the cost of medication for opioid use disorder (MOUD) with counseling for the adolescent and young adult population. This study calculated the health care utilization and cost of MOUD treatment, other substance use disorder treatment, and general health care for adolescents and young adults receiving treatment for opioid use disorder. METHODS: The study randomized youth ages 15 to 21 (N = 288) equally into the two study conditions: extended-release naltrexone (XR-NTX) or treatment as usual (TAU). While participants committed to treatment based on randomization the study observed considerable nonadherence to both randomized conditions. Instead of using the randomly assigned study conditions, we present descriptive costs by the type of MOUD treatment received: XR-NTX only, buprenorphine only, any other combination of MOUD treatments, and no MOUD. Health care use was aggregated over the 6-month period for each participant, and we calculated average/participant utilization for each treatment group. To determine participant costs, we multiplied the unit costs of health care services obtained from the literature by the reported amount of health care utilization for each participant. We then calculated the mean, standard error, median and IQR for MOUD costs, other substance use disorder treatment costs and general healthcare cost from the health care sector perspective. RESULTS: On average, participants in the XR-NTX only group received 2.6 doses of XR-NTX (equivalent to approximately 78 days of treatment). The buprenorphine only group had an average of 97 days of buprenorphine treatment. The XR-NTX only group had higher/patient costs compared to participants in the buprenorphine only group ($10,491 vs. $8765) and higher XR-NTX utilization would further increase costs. Participants in the any other MOUD combination group had the highest total costs ($14,627) while participants in the no MOUD group at the lowest ($3453). DISCUSSION: Our cost analysis calculates the real-world cost of MOUD treatment and, while not generalizable, provides policy makers an estimate of costs for adolescents and young adults. We found that participants in the XR-NTX only group received fewer days of medication compared to the buprenorphine only group, but their medication costs were higher due to the cost of XR-NTX injections. While the buprenorphine only group had the highest number of days of medication utilization of all the groups, the average number of days of medication utilization was considerably shorter than the six-month treatment period.

Sustainability of Adolescent Screening and Brief Intervention Services in Primary Care After Removal of Implementation Supports.

OBJECTIVE: Although many health care organizations have sought to increase the integration of substance use services into clinical practice, such practice changes can prove difficult to sustain. METHOD: Seven primary care clinics participated in an implementation study of screening and brief intervention (BI) services for adolescent patients (ages 12-17). All sites delivered screening and brief advice (BA) for low-risk use using a uniform protocol. Clinics were randomized to deliver BI using generalist (provider-delivered) or specialist (behavioral health clinician-delivered) models. Implementation was facilitated by multiple supporting activities (e.g., trainings, local "champion," electronic health record [EHR] integration of screening and documentation, individualized feedback, project-specific materials, etc.). Data on the penetration of screening, BA, and BI delivery (N = 14,486 adolescent patient visits) were abstracted from the EHR for the 20-month implementation phase and a 12-month sustainability phase (during which implementation supports were removed). RESULTS: Penetration of screening continued to slowly increase across the implementation-to-sustainability phases (62% vs. 70%; p = .04). Although uptake during implementation was low for BA (29%) and BI (22%), there was no significant decrease in service provision during the sustainability phase. Although overall delivery of BI was significantly higher in generalist compared with specialist sites (p < .001), sustainability did not differ by generalist versus specialist conditions. There were considerable differences in penetration across clinic sites. CONCLUSIONS: Clinics sustained a high level of substance use screening. Uptake of intervention services was low but did not decrease further following the cessation of implementation supports. This study illustrates the challenges of successfully implementing and sustaining substance use services in adolescent primary care.

Implementation Strategy Fidelity and Organizational Outcomes in a Randomized Trial: Implications for Reentry from Corrections to Community Treatment.

Background: This study examined fidelity of implementation strategies used in an organizational process improvement intervention (OPII) designed to improve evidence-based practices related to assessments for drug-involved clients exiting incarceration. Leadership was studied as a moderating factor between fidelity and outcomes. Methods: A mixed-method cluster randomized design was used to randomize 21 sites to early- or delayed-start within 9 research centers. Parent study protocol was reviewed to develop fidelity constructs (i.e., responsiveness, dose, quality, adherence). Outcomes were site-level success in achieving goals and objectives completed during the OPII (e.g., percent goals achieved). Correlations, analyses of covariance, regressions and moderation analyses were performed. Qualitative interviews assessed facilitators/barriers to implementation. Results: Fidelity constructs related to outcomes. No differences were found in fidelity by early or delayed condition. At low levels of leadership, high staff responsiveness (i.e., engagement in the OPII) related to poorer outcome. Conclusions: It is important to consider contextual factors (e.g., leadership) that may influence implementation strategy fidelity when deploying evidence-based practices. Findings are relevant to researchers, clinicians, administrators and policy makers, and suggest that goal completion during implementation of evidence-based practices requires monitoring of leadership competence, fidelity to implementation strategies (i.e., staff responsiveness to strategies) and attendance to goal importance.

The impact of COVID-19 on the treatment of opioid use disorder in carceral facilities: a cross-sectional study.

While the COVID-19 pandemic disrupted healthcare delivery everywhere, persons with carceral system involvement and opioid use disorder (OUD) were disproportionately impacted and vulnerable to severe COVID-associated illness. Carceral settings and community treatment programs (CTPs) rapidly developed protocols to sustain healthcare delivery while reducing risk of COVID-19 transmission. This survey study assessed changes to OUD treatment, telemedicine use, and re-entry support services among carceral and CTPs participating in the National Institute on Drug Abuse (NIDA)-funded study, Long-Acting Buprenorphine vs. Naltrexone Opioid Treatments in Criminal Justice System-Involved Adults (EXIT-CJS) study. In December 2020, carceral sites (n = 6; median pre-COVID 2020 monthly census = 3468 people) and CTPs (n = 7; median pre-COVID 2020 monthly census = 550 patients) participating in EXIT-CJS completed a cross-sectional web-based survey. The survey assessed changes pre- (January-March 2020) and post- (April-September 2020) COVID-19 in OUD treatment, telemedicine use, re-entry supports and referral practices. Compared to January-March 2020, half of carceral sites (n = 3) increased the total number of persons initiating medication for opioid use disorder (MOUD) from April-September 2020, while a third (n = 2) decreased the number of persons initiated. Most CTPs (n = 4) reported a decrease in the number of new admissions from April-September 2020, with two programs stopping or pausing MOUD programs due to COVID-19. All carceral sites with pre-COVID telemedicine use (n = 5) increased or maintained telemedicine use, and all CTPs providing MOUD (n = 6) increased telemedicine use. While expansion of telemedicine services supported MOUD service delivery, the majority of sites experienced challenges providing community support post-release, including referrals to housing, employment, and transportation services. During the COVID-19 pandemic, this small sample of carceral and CTP sites innovated to continue delivery of treatment for OUD. Expansion of telemedicine services was critical to support MOUD service delivery. Despite these innovations, sites experienced challenges providing reintegration supports for persons in the community. Pre-COVID strategies for identifying and engaging individuals while incarcerated may be less effective since the pandemic. In addition to expanding research on the most effective telemedicine practices for carceral settings, research exploring strategies to expand housing and employment support during reintegration are critical.

Feasibility, Acceptability, and Preliminary Outcomes of an Integrated Telemedicine Intervention Combining Naltrexone and Cognitive Behavioral Therapy for Alcohol Use Disorder.

Background: A small fraction of individuals in need of treatment for alcohol use disorders (AUDs) seek care, owing largely to barriers to accessing treatment. In the present pilot study, we examine the feasibility, acceptability, and preliminary outcomes of an m-health intervention combining cognitive behavioral therapy and pharmacotherapy for individuals with AUD. Methods: Adults with AUD (N = 26) recruited through online, social media-based advertising were enrolled in a 12-week, integrated telemedicine intervention combining psychosocial treatment with medical management: Quit Genius for AUD (QG-A). Feasibility, acceptability, perceived helpfulness, treatment engagement, retention, completion, and clinical outcomes including alcohol use and secondary mental health outcomes were assessed. Results: Participants found the QG-A intervention to be acceptable and helpful in facilitating action toward their therapeutic goals concerning alcohol use. Treatment completion, achieved by the majority (85%) of participants, was excellent. On average, participants reduced their past 30-day alcohol use from baseline (mean proportion of days of abstinent = 0.13) to follow-up (M = 0.59), t(19) = -4.97, p < 0.001, and consumed fewer drinks per drinking day from baseline (M = 6.7) to follow-up (M = 2.0), t(19) = 3.61, p < 0.001. Concurrently, reductions were observed in depressive (t[22] = 5.39, p < 0.001) and anxiety (t[22] = 2.87, p < 0.01) symptom severity, from the moderately severe range at baseline to the mild range at treatment-end, with increases in resilience (t[22] = -3.54, p < 0.001). Conclusions: Addressing AUDs using an integrated m-health intervention to deliver evidence-based psychosocial and pharmacological treatment is feasible and may produce improvements in both alcohol use and psychiatric symptoms.

Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention.

PURPOSE: The Facilitating Change for Excellence in SBIRT (FaCES) is a service package for adolescent primary care that was developed based on best practices and evidence, but was empirically untested. The aim of this study is to compare the FaCES intervention to treatment as usual (TAU) for rural adolescent primary care patients. METHODS: In this modified cluster-randomized stepped wedge design, providers who completed at least 20 adolescent TAU visits received training in the FaCES package in random order. Adolescent patients (N = 1,226) waiting for appointments were continuously recruited into the study and completed a baseline assessment before their scheduled appointment and an on-line 3-month follow-up. Participants received either FaCES or TAU, depending on whether their provider had been trained in FaCES. Due to COVID-19 disruptions, only 14 of the 29 providers were trained before study recruitment activities ceased. RESULTS: More than 80% of the sample indicated no prior use of tobacco, alcohol, or marijuana at study entry. The Arm × Time interaction failed to reach significance for the substance use outcomes considered. In the FaCES condition, the group with no prior use had an increased probability of substance use at 3-month follow-up, while the group reporting prior use had a decreased probability of use at follow-up. Participants who reported no use at baseline had an increased probability of use at follow-up, whether they received the FaCES intervention or TAU. DISCUSSION: This study was unable to demonstrate the effectiveness of FaCES. Findings suggest some natural movement in substance use risk over time.

Development and use of a checklist for the implementation of medication for opioid use disorder in jails.

Background: In light of short lengths of stay and proximity to communities of release, jails are well-positioned to intervene in opioid use disorder (OUD). However, a number of barriers have resulted in a slow and limited implementation. Methods: This paper describes the development and testing of a Medication for Opioid Use Disorder (MOUD) Implementation Checklist developed as part of a Building Bridges project, a two-year planning grant which supported 16 US jail systems as they prepared to implement or expand MOUD services. Results: Although initially developed to track changes within sites participating in the initiative, participants noted its utility for identifying evidence-based benchmarks through which the successful implementation of MOUDs could be tracked by correctional administrators. Conclusions: The findings suggest that this checklist can both help guide and illustrate progress toward vital changes facilitated through established processes and supports. Plain Language Summary: People incarcerated in jails are more likely to have opioid use disorder than the general population. Despite this, jails in the United States (U.S.) often offer limited or no access to Medication for Opioid Use Disorder (MOUD). The Building Bridges project was designed to address this gap in 16 U.S. jail systems as they prepared to implement or expand MOUD services. This article addresses the use of a MOUD checklist that was initially designed to help the jails track changes toward evidence-based benchmarks. The findings suggest that this checklist can both help guide and illustrate progress toward vital changes facilitated through established processes and supports.

Post-residential treatment outpatient care preferences: Perspectives of youth with opioid use disorder.

INTRODUCTION: We know little about what youth with opioid use disorders (OUD) think about outpatient substance use treatment and 12-step meetings following discharge from residential substance use treatment. This study explores youths' preferences between intensive outpatient treatment (IOP) and community-based 12-step groups. METHOD: The study recruited youth (n = 35) from a larger randomized trial (N = 288) that examined the effectiveness of extended-release naltrexone versus treatment-as-usual. This study asked the youth to participate in semi-structured qualitative interviews at baseline, 3 months, and 6 months post-residential treatment discharge. Qualitative interviews probed youths' key decision points during the six-months following residential treatment for OUD, including medication and counseling, and 12-step continuation in the community. RESULTS: Qualitative analyses revealed three overarching themes related to youths' preferences for either IOP or 12-step meetings: structure of recovery support, mechanisms of accountability, and relationships. CONCLUSION: Despite varying preferences, this analysis highlights the complexity of benefits that youth report receiving from each approach. Research has yet to determine the degree to which these approaches are complementary or supplementary for this population.

Organizational Acceptability of Implementing SBIRT for Adolescents in Primary Care.

INTRODUCTION: Adolescent illicit drug, tobacco, and alcohol use can result in sudden and long-term negative health consequences. Primary care environments present the optimal opportunity for screening and brief interventions that target prevention and curtailing use. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a service delivery method that could potentially be well-integrated into primary care settings and used to serve a high volume of adolescents. Methods: This qualitative analysis of clinic staff interviews (N = 20), collected during a large cluster-randomized trial to implement two models of adolescent SBIRT, examined barriers and facilitating factors to overall acceptability of SBIRT. This study was conducted in a large, urban Federally Qualified Health Center (FQHC) at 7 sites throughout Baltimore City, Maryland, USA. Participants from each clinic included a range of various roles and responsibilities including: medical assistants (n = 3), nurses (n = 3), primary care providers (n = 4), behavioral health counselors (n = 4), and administrators (n = 6). Results: Results indicate both barriers and facilitating factors for acceptability of SBIRT in terms of (1) universal screening, (2) provider time demands, (3) behavioral health collaboration, and (4) behavioral health caseloads. Discussion: Universal screening was acceptable to participants across organizational roles, but brief interventions and referrals to treatment were found substantially less acceptable.

Use of non-prescribed buprenorphine in the criminal justice system: Perspectives of individuals recently released from incarceration.

Buprenorphine, an effective treatment for opioid use disorder (OUD), remains underutilized in many U.S. jails and prisons. However, use of non-prescribed (i.e., diverted) buprenorphine has been reported in these settings. The current study examined non-prescribed buprenorphine use experiences in correctional and community contexts. The study conducted face-to-face interviews with 300 adults with OUD/opioid misuse and recent incarceration, recruited in Baltimore, MD, and New York, NY (n = 150 each). Illicit/non-prescribed opioid use during incarceration was reported by 63% of participants; 39% reported non-prescribed buprenorphine. Non-prescribed buprenorphine was considered the most widely available opioid in jails/prisons in both states (81% reported "very" or "somewhat" easy to get). The average price of non-prescribed buprenorphine in jail/prison was ~10× higher than in the community (p < 0.001). Participants were more likely to endorse getting high/mood alteration as reasons for using non-prescribed buprenorphine during incarceration, but tended to ascribe therapeutic motives to use in the community (e.g., self-treatment; p < 0.001). Multivariable logistic regression analyses showed that different individual-level characteristics were associated with history of non-prescribed buprenorphine use during incarceration and in the community. Use of non-prescribed buprenorphine during incarceration was associated with younger age (p = 0.006) and longer incarceration history (p < 0.001), while use of non-prescribed buprenorphine in the community was associated with MD recruitment site (p = 0.001), not being married (p < 0.001), prior buprenorphine treatment experience (p < 0.001), and housing situation (p = 0.01). These findings suggest that different dynamics and demand characteristics underlie the use of non-prescribed buprenorphine in community and incarceration contexts, with implications for efforts to expand OUD treatment in correctional settings.

Views of barriers and facilitators to continuing methadone treatment upon release from jail among people receiving patient navigation services.

BACKGROUND: Patient navigation has potential for assisting patients who initiate methadone during pretrial detention to enter and remain in treatment following release, but we know little about participants' experiences with this service. METHODS: This study drew a purposive sample of male and female participants (N = 17) from participants enrolled in a randomized trial of initiating methadone with vs. without patient navigation while in the Baltimore City Detention Center. The study interviewed participants in the community at 1 and 3 months following release and asked them about their experiences of reentry, methadone treatment continuation, drug use, and interactions with the patient navigator. The study recorded, transcribed, coded using Atlas.ti, and analyzed thematically the interviews. RESULTS: Participants reported encountering four key challenges in the community: getting to treatment following release, assembling basic supports, managing criminal justice system demands, and staying in treatment. Participants' experiences of the patient navigator's support to address these challenges fell into six thematic groups: showing nonjudgmental caring and persistence, advocating within programs, brokering resources, managing interactions with the criminal justice system, balancing encouragement and self-determination, and offering genuine and familial-type support. CONCLUSION: Nearly all participants appreciated the navigator's support and deemed it helpful. The previously reported randomized trial found that participants assigned to initiate methadone treatment with navigation had higher rates of receiving their first "guest" methadone dose in the community but did not have significantly different rates of treatment enrollment or of illicit opioid use compared to those assigned to begin methadone treatment without navigation. Treatment programs should work to improve retention and postrelease outcomes among this population.

Extended-release naltrexone for youth with opioid use disorder.

BACKGROUND: Few published research studies have examined the effectiveness of extended-release naltrexone (XR-NTX) for the treatment of opioid use disorder (OUD) among adolescents and young adults. METHODS: This two-group randomized controlled trial recruited 288 youth, ages 15-21, with moderate/severe OUD from a residential addiction treatment program in Baltimore, Maryland. The study randomized the youth within the first week of treatment entry to receive either XR-NTX or treatment-as-usual (TAU; either buprenorphine maintenance treatment or treatment without OUD medication following medically managed withdrawal) prior to discharge, with continued treatment in the community for 6 months. However, due to various reasons spanning patients' and caregivers' preferences and constraints, considerable participant nonadherence to randomized condition occurred (i.e., only 30% of the participants randomized to XR-NTX received an initial injection, while 27% of participants randomized to TAU received an XR-NTX injection at treatment discharge, instead of their assigned treatment). The study used generalized linear mixed modeling (GLiMM) to examine self-reported 90-day opioid, cocaine, marijuana, and alcohol use as well as DSM-5 OUD criteria on "intention-to-treat" (as randomized), "as-received" (XR-NTX vs. not XR-NTX), and "as-medicated" (XR-NTX vs. buprenorphine vs. no medication) bases. RESULTS: The condition x time interactions in the intention-to-treat analyses failed to reach significance for past-90-day self-reported use of illicit opioids, cocaine, marijuana, or alcohol, or in meeting DSM-5 OUD criteria at 3 or 6 months [all ps > 0.05]. However, these findings are of limited interpretive value due to participant nonadherence to their randomized condition. When the study analyzed results by the treatment received at discharge, the "as-received" group x time interaction for illicit opioid use was significant [p = .003], with the XR-NTX group reporting less opioid use in the past 90 days at 3 and 6 months. Participants who received their first XR-NTX dose at inpatient discharge (n = 82) received, on average, 1.3 subsequent injections in the community over the 6-month study follow-up period. Only 2 of the 82 study participants received XR-NTX continuously through the 6-month postdischarge follow-up period. Twelve serious adverse events (SAEs) occurred during the study, but the study determined that only 1 was possibly study related (hepatitis C/elevated liver function test results). CONCLUSION: None of the condition x time interactions in the intention-to-treat analyses reached significance. Participants' nonadherence may have contributed to the failure to reject the null hypothesis. Irrespective of randomized condition, participants who received XR-NTX for OUD demonstrated low retention in treatment, receiving an average of only 1.3 subsequent injections, yet reported less opioid use at follow-up than participants who did not received XR-NTX. Treatment programs should consider XR-NTX as a treatment option for youth motivated to receive it. Future research should focus on building developmentally informed strategies to improve uptake of and adherence to relapse prevention medication in this population.

Drug and sexual HIV-risk behaviors among adolescents and young adults with opioid use disorder.

Opioid use disorder (OUD) among adolescents and young adults (youth) is associated with drug use and sexual HIV-related risk behaviors and opioid overdose. This mixed methods analysis assesses risk behaviors among a sample of 15-21-year-olds (N = 288) who were being treated for OUD in a residential drug treatment program in Baltimore, Maryland. Participants were enrolled in a parent study in which they received either extended-release naltrexone (XR-NTX) or Treatment as Usual (TAU), consisting of outpatient counseling with or without buprenorphine, prior to discharge. At baseline, participants were administered the HIV-Risk Assessment Battery (RAB), and clinical intake records were reviewed to determine participants' history of sexual, physical, or other abuse, as well as parental and partner substance use. A sub-sample of study participants completed semi-structured qualitative interviews (N = 35) at baseline, three-, and six-month follow-up periods. This analysis identified gender (e.g., female IRR = 1.63, CI 1.10-2.42, p = .014), the experience of dependence (e.g., previous detoxification IRR = 1.08, CI 1.01-1.15, p = .033) and withdrawal (e.g., severe withdrawal symptoms IRR = 1.41, CI 1.08-1.84, p = .012), and the role of relationships (e.g., using with partner IRR = 2.45, CI 1.15-5.22, p = .021) as influencing high-risk substance use behaviors. Similarly, high-risk sex was influenced by gender (e.g., female IRR = 1.43, CI 1.28-1.59, p < .001), and the role of relationships (e.g., using with partner IRR = 0.78, CI 0.62-0.98, p = .036). These are key targets for future prevention, treatment, and intervention.

Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS).

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.

Until there's nothing left: Caregiver resource provision to youth with opioid use disorders.

Background and Aims: Despite the considerable literature associating certain characteristics of caregivers and family structures with risks of adolescent/young adult (youth) substance use, there has been little study of the role of caregivers in opioid use disorder (OUD) treatment outcomes. This qualitative study sought to understand and contextualize the factors that influenced the resources caregivers provided their youth after residential treatment. Methods: In order to improve understandings of the role caregivers play both during and after residential OUD treatment, 31 caregivers of youth who were in a residential substance use disorder treatment center were interviewed at baseline, three-months, and six-months following their youth's discharge. Results: This analysis focused on the provision of caregiver resources and identified three key influences - OUD understandings and expectations, relationships with youth, and the emotional toll on caregivers. This has important implications as residential treatment success rates are relatively low among this population. Conclusions: These findings suggest that engagement of caregivers and families in outpatient care following residential treatment could offer an important opportunity for interventions that promote youth recovery.

Exploring nonprescribed use of buprenorphine in the criminal justice system through qualitative interviews among individuals recently released from incarceration.

BACKGROUND: Buprenorphine treatment remains unavailable in many jails and prisons, but use of nonprescribed (i.e., diverted) buprenorphine has been reported in these settings. The purpose of this analysis is to explore the experiences and motivations behind the use of diverted buprenorphine among recently incarcerated individuals. METHODS: Adults with opioid misuse who were recently released from jail or prison (n= 26; 58% male) completed semi-structured qualitative interviews as part of a study focused on buprenorphine diversion in the criminal justice system. Qualitative interviews explored participants' incarceration experiences and opioid use background, knowledge of buprenorphine and other substance use in jails/prisons, personal use of buprenorphine while incarcerated, reasons for using buprenorphine while incarcerated, and knowledge of how buprenorphine is brought into and acquired in jails/prisons. The study recorded and transcribed interviews, and analyzed the narratives for content related to these predetermined thematic areas. RESULTS: Key themes emerging from the interviews surrounding buprenorphine diversion during incarceration included: 1) the perceived high prevalence of diverted buprenorphine in jail/prison settings, 2) how the perception of prevalence is related to buprenorphine sublingual film formulation, 3) adaptive routes of administration related to the high cost of diverted buprenorphine, and 4) reasons individuals who are incarcerated use diverted buprenorphine (to achieve euphoric effects and cope with confinement, in contrast to using for self-treatment/withdrawal management as is done in the community). CONCLUSION: Participants reported widespread availability of diverted buprenorphine in criminal justice facilities, and characterized reasons for its use specific to these contexts. More research is needed to determine the impact of expanding buprenorphine treatment in jails and prisons on inmates' use of diverted buprenorphine, and future research should explore these intersections as treatment initiation opportunities.