Rapid Initiation of Injection Naltrexone for Opioid Use Disorder: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Injectable extended-release (XR)-naltrexone is an effective treatment option for opioid use disorder (OUD), but the need to withdraw patients from opioid treatment prior to initiation is a barrier to implementation. Objective: To compare the effectiveness of the standard procedure (SP) with the rapid procedure (RP) for XR-naltrexone initiation. Design, Setting, and Participants: The Surmounting Withdrawal to Initiate Fast Treatment with Naltrexone study was an optimized stepped-wedge cluster randomized trial conducted at 6 community-based inpatient addiction treatment units. Units using the SP were randomly assigned at 14-week intervals to implement the RP. Participants admitted with OUD received the procedure the unit was delivering at the time of their admission. Participant recruitment took place between March 16, 2021, and July 18, 2022. The last visit was September 21, 2022. Interventions: Standard procedure, based on the XR-naltrexone package insert (approximately 5-day buprenorphine taper followed by a 7- to 10-day opioid-free period and RP, defined as 1 day of buprenorphine at minimum necessary dose, 1 opioid-free day, and ascending low doses of oral naltrexone and adjunctive medications (eg, clonidine, clonazepam, antiemetics) for opioid withdrawal. Main Outcomes and Measures: Receipt of XR-naltrexone injection prior to inpatient discharge (primary outcome). Secondary outcomes included opioid withdrawal scores and targeted safety events and serious adverse events. All analyses were intention-to-treat. Results: A total of 415 participants with OUD were enrolled (mean [SD] age, 33.6 [8.48] years; 205 [49.4%] identified sex as male); 54 [13.0%] individuals identified as Black, 91 [21.9%] as Hispanic, 290 [69.9%] as White, and 22 [5.3%] as multiracial. Rates of successful initiation of XR-naltrexone among the RP group (141 of 225 [62.7%]) were noninferior to those of the SP group (68 of 190 [35.8%]) (odds ratio [OR], 3.60; 95% CI, 2.12-6.10). Withdrawal did not differ significantly between conditions (proportion of days with a moderate or greater maximum Clinical Opiate Withdrawal Scale score (>12) for RP vs SP: OR, 1.25; 95% CI, 0.62-2.50). Targeted safety events (RP: 12 [5.3%]; SP: 4 [2.1%]) and serious adverse events (RP: 15 [6.7%]; SP: 3 [1.6%]) were infrequent but occurred more often with RP than SP. Conclusions and Relevance: In this trial, the RP of XR-naltrexone initiation was noninferior to the standard approach and saved time, although it required more intensive medical management and safety monitoring. The results of this trial suggest that rapid initiation could make XR-naltrexone a more viable treatment for patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT04762537.

Stress Exposure and PTSD in a Cross-Sectional Residential Substance Use Treatment Sample.

BACKGROUND: Aim 1 of this cross-sectional, observational study with people in residential treatment for substance use disorders (SUDs) was to document stress exposure. Aim 2 was to assess potential sociodemographic and health differences based on probable posttraumatic stress disorder (PTSD) status. Aim 3 was to assess relative contributions of Diagnostic and Statistical Manual (DSM)-congruent versus DSM-incongruent stressors (Criterion A vs non-Criterion A) to mental and physical health. We hypothesized that both types of stressors would significantly contribute to impairment across indicators and that DSM-congruent stressor exposure would be more strongly associated with impairment than DSM-incongruent exposure. METHODS: We assessed exposure to DSM-congruent traumatic stressors and DSM-incongruent life stressors, PTSD and depressive symptoms, emotion regulation difficulties, substance use recovery capital, and physical/mental health-related quality of life among 136 people in residential SUD treatment who were 64% men, 36% women; 49% white, 41% Black, 11% multiracial/another race; 18% lesbian, gay, or bisexual (LGB+); mean age = 39.82 (standard deviation = 12.24) years. RESULTS: Participants reported experiencing a mean of 9.76 (SD = 6.11) DSM-congruent events. Those with probable PTSD were younger and more likely to be LGB+ than those without probable PTSD (P < .05). Experiencing higher numbers of DSM-congruent events was associated with more severe PTSD and depressive symptoms, emotion regulation difficulties, and lower physical health-related quality of life (P < .05). DSM-incongruent stressor exposure was not independently associated with any indicators. Recovery capital was not associated with either type of stress exposure. CONCLUSIONS: Stressful event exposure among people in residential SUD treatment is very high. Those who are younger or LGB+ in residential SUD treatment may be at greater risk of developing PTSD. DSM-congruent stressors are more consistently associated with mental health indicators than are DSM-incongruent stressors. Prioritizing treatment targets and identifying implementable treatment strategies can be challenging with this complex population.

A pilot randomized controlled trial of medication adherence therapy: Psychosocial leverage using a significant other (MAT-PLUS) for individuals on extended-release naltrexone.

BACKGROUND: Extended-release naltrexone (XR-NTX) is an important treatment option for individuals with opioid use disorder (OUD) and/or alcohol use disorder (AUD). However, problems with retention are a major barrier to its overall effectiveness, and interventions to improve adherence are underdeveloped. The purpose of this study was to pilot test the MAT-PLUS intervention, which combines assertive outreach and involvement of a treatment significant other (TSO) to improve adherence to XR-NTX. METHODS: Adults (N = 41) seeking treatment for OUD and/or AUD with XR-NTX were recruited from an inpatient addiction treatment center and randomized to the MAT-PLUS intervention or treatment as usual (TAU) for 16-weeks. TSOs (N = 19) of individuals in the MAT-PLUS condition were also enrolled. The primary outcome was the number of XR-NTX doses received and relapse to regular heavy use (opioid or alcohol) was a secondary outcome. RESULTS: Participants in the MAT-PLUS group received 3.4 doses compared to 2.5 in TAU, which was significant after controlling for SUD diagnosis (p < 0.05). Rates of receipts of all prescribed doses were 61.1 % in MAT-PLUS compared to 30.4 % in TAU, giving an NNT of 3.3. Relapse rates and days of heavy use did not vary by treatment group. CONCLUSIONS: This study demonstrates preliminary efficacy of the MAT-PLUS intervention for XR-NTX adherence. This study was limited by its small sample size and future research should broaden the intervention to apply across medications for SUD in larger samples. Family support with an emphasis on medication adherence has strong potential for improving addiction treatment outcomes.

Engagement, initiation, and retention in medication treatment for opioid use disorder among young adults: A narrative review of challenges and opportunities.

INTRODUCTION: Opioid Use Disorder (OUD) is a catastrophic public health problem for young adults (YAs) and their families. While medication for OUD (MOUD) is safe, effective, and recognized as the standard of care, its' uptake and success have been limited in YAs compared to older adults. METHODS: This narrative review summarizes the existing literature and highlights select studies regarding barriers to YA MOUD, potential explanations for those barriers, and strategies to overcome them. RESULTS: Barriers are prominent along the entire cascade of care, including: treatment engagement and entry, MOUD initiation, and MOUD retention. Hypothesized explanations for barriers include: developmental vulnerability, inadequate treatment system capacity, stigma against MOUD, among others. Interventions to address barriers include: promotion of family involvement, increasing provider capacity, integration of MOUD into primary care, assertive outreach, and others. CONCLUSIONS: Integrating an adapted version of family coaching from the Community Reinforcement Approach and Family Training (CRAFT) and other models into YA MOUD treatment serves as an example of an emerging novel practice that holds promise for broadening the funnel of engagement in treatment and initiation of MOUD, and enhancing treatment outcomes. This and other developmentally-informed approaches should be evaluated as part of a high-priority clinical and research agenda for improving OUD treatment for YAs.

Linkage facilitation services for opioid use disorder: Taxonomy of facilitation practitioners, goals, and activities.

INTRODUCTION: This article proposes a taxonomy of linkage facilitation services used to help persons with opioid use disorder access treatment and recovery resources. Linkage facilitation may be especially valuable for persons receiving medication for opioid use disorder (MOUD) given the considerable barriers to treatment access and initiation that have been identified. The science of linkage facilitation currently lacks both consistent communication about linkage facilitation practices and a conceptual framework for guiding research. METHODS: To address this gap, this article presents a taxonomy derived from expert consensus that organizes the array of practitioners, goals, and activities associated with linkage services for OUD and related needs. Expert panelists first independently reviewed research reports and policy guidelines summarizing the science and practice of linkage facilitation for substance use disorders generally and OUD specifically, then met several times to vet the conceptual scheme and content of the taxonomy until they reached a final consensus. RESULTS: The derived taxonomy contains eight domains: facilitator identity, facilitator lived experience, linkage client, facilitator-client relationship, linkage activity, linkage method, linkage connectivity, and linkage goal. For each domain, the article defines basic domain categories, highlights research and practice themes in substance use and OUD care, and introduces innovations in linkage facilitation being tested in one of two NIDA-funded research networks: Justice Community Opioid Innovation Network (JCOIN) or Consortium on Addiction Recovery Science (CoARS). CONCLUSIONS: To accelerate consistent application of this taxonomy to diverse research and practice settings, the article concludes by naming several considerations for linkage facilitation workforce training and implementation.

Launching Relationship-Oriented Behavioral Services for Youth Opioid Use Disorder: Innovations in Medication Decision-Making and Adherence Planning.

This article presents behavioral interventions designed to enhance uptake and retention on medication for opioid use disorder (MOUD) among transition-age youth (16-25 years) enrolled in treatment services. The article describes three relationship-oriented interventions designed to address barriers to MOUD uptake, enhance MOUD adherence planning, and strengthen OUD recovery among youth: Relational Orientation; Medication Education and Decision-making Support, and Family Leadership and Ownership of Adherence to Treatment. These interventions are inter-connected can be delivered flexibly. The article concludes with three case examples that illustrate how these modular interventions can be tailored to meet the needs of diverse client profiles.

Impact of Medication-Based Treatment on Health Care Utilization Among Individuals With Opioid Use Disorder.

OBJECTIVE: This study evaluated the association between medication for opioid use disorder (MOUD) and health care utilization over time among a sample of treatment-seeking individuals with opioid use disorder. In contrast to previous studies, this study used a novel measure of MOUD adherence, more comprehensive utilization data, and analyses that controlled for detailed individual and social determinants of health. METHODS: This study was a secondary analysis of a comparative effectiveness trial (N=570) of extended-release naltrexone versus buprenorphine-naloxone. The outcome of interest was usage of nonstudy acute care, inpatient and outpatient addiction services, and other outpatient services across 36 weeks of assessment. Adherence (percentage of days taking MOUD) was defined as low (<20%), medium (≥20% but <80%), or high (≥80%). A two-part model evaluated the probability of utilizing a resource and the quantity (utilization days) of the resource consumed. A time-varying approach was used to examine the effect of adherence in a given month on utilization in the same month, with analyses controlling for a wide range of person-level characteristics. RESULTS: Participants with high adherence (vs. low) were significantly less likely to use inpatient addiction (p<0.001) and acute care (p<0.001) services and significantly more likely to engage in outpatient addiction (p=0.045) and other outpatient (p=0.042) services. CONCLUSIONS: These findings reinforce the understanding that greater MOUD adherence is associated with reduced usage of high-cost health services and increased usage of outpatient care. The results further suggest the need for enhanced access to MOUD and for interventions that improve adherence.

A pilot test of Written Exposure Therapy for PTSD in residential substance use treatment.

BACKGROUND AND OBJECTIVES: Posttraumatic stress disorder (PTSD) is highly comorbid with substance use disorders (SUD) and can impede SUD recovery. Residential SUD treatment is a crucial opportunity to address PTSD. However, PTSD treatment is lacking in residential SUD care. METHODS: We conducted a nonrandomized feasibility study of Written Exposure Therapy (WET), a brief, evidence-based treatment for PTSD, with patients in residential SUD treatment. We assessed attitudes towards treatment (Credibility and Expectancy Questionnaire, Barriers to Treatment Participation Scale) and mental health indicators (PTSD Checklist for DSM-5, Trauma Coping Self-Efficacy, Difficulties in Emotion Regulation-Short Form, and Brief Assessment of Recovery Capital). RESULTS: Thirty of 49 eligible participants completed WET (61%) and 92% (n = 45) attended at least one WET session. Paired sample t-tests revealed significant posttreatment improvement across all mental health indicators, with medium to large effect sizes. DISCUSSION AND CONCLUSIONS: Attendance and completion rates compared favorably to prior exposure-based treatment for PTSD in SUD settings. Although causality cannot be inferred without a randomized controlled trial, mental health indicators, including PTSD, improved significantly following WET. SCIENTIFIC SIGNIFICANCE: These findings provide evidence that PTSD can be successfully treated in short-term residential care using brief exposure-based interventions, which is a crucial clinical need that has been minimally studied in the past.

Trajectories of depression among patients in treatment for opioid use disorder: A growth mixture model secondary analysis of the XBOT trial.

BACKGROUND AND OBJECTIVES: To inform clinical practice, we identified subgroups of adults based on levels of depression symptomatology over time during opioid use disorder (OUD) treatment. METHODS: Participants were 474 adults in a 24-week treatment trial for OUD. Depression symptoms were measured using the 17-item Hamilton Depression Rating Scale (HAM-D) at nine-time points. This was a secondary analysis of the Clinical Trials Network Extended-Release Naltrexone versus Buprenorphine for Opioid Treatment (XBOT) trial using a growth mixture model. RESULTS: Three distinct depression trajectories were identified: Class 1 High Recurring-10% with high HAM-D with initial partial reductions (of HAM-D across time), Class 2 Persistently High-5% with persistently high HAM-D, and Class 3 Low Declining-85% of the participants, with low HAM-D with early sustained reductions. The majority (low declining) had levels of depression that improved in the first 4 weeks and then stabilized across the treatment period. In contrast, 15% (high recurring and persistently high) had high initial levels that were more variable across time. The persistently high class had higher rates of opioid relapse. DISCUSSION AND CONCLUSIONS: In this OUD sample, most depressive symptomatology was mild and improved after medication treatment for opioid use disorder (MOUD). Smaller subgroups had higher depressive symptoms that persisted or recurred after the initiation of MOUD. Depressive symptoms should be followed in patients initiating treatment for OUD, and when persistent, should prompt further evaluation and consideration of antidepressant treatment. SCIENTIFIC SIGNIFICANCE: This study is the first to identify three distinct depression trajectories among a large clinical sample of individuals in MOUD treatment.

Relationship-Oriented Recovery System for Youth (RORSY): Clinical Protocol for Transition-Age Youth with Opioid Use Disorders.

This article introduces the Relationship-Oriented Recovery System for Youth (RORSY) protocol, which is designed to increase uptake of Medications for Opioid Use Disorder (MOUD) and related services among adolescents and young adults. Youth exhibit alarmingly poor rates of MOUD initiation and adherence, OUD services involvement and long-term recovery success. RORSY attends to three developmentally unique recovery needs of this age group: assess and bolster youth recovery capital, prioritize involvement of concerned significant others, and use digital direct-to-consumer recovery supports. RORSY contains five evidence-informed intervention modules that can be flexibly tailored to meet the individual and relationship needs of a given youth: Relational Orientation, Youth Recovery Management Planning, Relational Recovery Management Planning, Relationship Skills Building, and Digital Recovery Support Planning. The article concludes with practice and policy recommendations for making relationship-building a top clinical priority for addressing youth OUD.

Assessing clinical impacts and attitudes related to COVID-19 among residential substance use disorder patients.

Background: Individuals with substance use disorder (SUD) may be particularly at risk during the COVID-19 pandemic. The purpose of this study was to examine attitudes to the pandemic among individuals with SUD. Methods: Survey responses from 266 patients entering a residential treatment program were analyzed. Results: Most participants were White or African American men. A third of participants reported that their substance use had increased during the pandemic (38%), and that they had stockpiled substances because of concerns about supply (30%). A majority of participants indicated more depression (60%), anxiety (61%), worry about finances (62%), and feeling worse about their substance use due to COVID-19 (67%). An exploratory factor analysis revealed five factors that measured interest in SUD treatment, psychological symptoms, adherence to health recommendations, perceptions of vulnerability to COVID-19, and substance use during COVID-19. African American participants indicated a greater interest in treatment than Whites, while White participants indicated increased symptoms and substance use during COVID-19 (p < .05). Further, African Americans were more likely to have known someone who had developed COVID-19 than whites (p < .05). Older participants indicated adhering to health recommendations more than younger participants, using substances less than younger participants, as well as feeling more vulnerable to COVID-19 (p < .05). Conclusions: This is the first study to examine patient attitudes and behaviors related to COVID-19 at a residential SUD treatment program. Treatment providers should be aware of patient attitudes and behaviors related to COVID-19 paying special attention to barriers to treatment engagement.

Therapy Dose Mediates the Relationship Between Buprenorphine/Naloxone and Opioid Treatment Outcomes in Youth Receiving Medication for Opioid Use Disorder Treatment.

BACKGROUND: Evidence-based interventions for treating opioid use disorder (OUD) in youth are limited and little is known about specific and general mechanisms of OUD treatments and how they promote abstinence. METHODS: The present study used data from the NIDA-CTN-0010 trial to evaluate the mediating effects of psychosocial treatment-related variables (therapy dose and therapeutic alliance) on end-of-treatment opioid abstinence in a sample of youth with OUD (n = 152, 40% female, mean age = 19.7 years) randomized to receive either 12-weeks of treatment with Bup/Nal ("Bup-Nal") or up to 2 weeks of Bup/Nal detoxification ("Detox") with both treatment arms receiving weekly individual and group drug counseling ± family therapy. RESULTS: Participants in the Bup-Nal group attended more therapy sessions (16 vs 6 sessions), had increased therapeutic alliance at week-4, and had less opioid use by week-12 compared to those in the Detox group. In both treatment arms, youth who attended more therapy sessions were less likely to have a week-12 opioid positive urine. In a multiple mediator model, therapy dose mediated the association between treatment arm and opioid abstinence. CONCLUSIONS: These findings provide preliminary support for a "dose-response" effect of addiction-focused therapy on abstinence in youth OUD. Further, the results identified a mediating effect of therapy dose on the relationship between treatment assignment and opioid treatment outcomes, suggesting that extended Bup-Nal treatment may enhance abstinence, in part, through a mechanism of therapy facilitation, by increasing therapy dose during treatment.

Sex-based differences in psychiatric symptoms and opioid abstinence during buprenorphine/naloxone treatment in adolescents with opioid use disorders.

BACKGROUND: Recent studies indicate that sex-based differences exist in co-occurring psychiatric symptoms and disorders among individuals with opioid use disorders (OUD). Whether these associations are present in adolescent samples and change during OUD treatment is poorly understood. OBJECTIVES: In the current study, we examined sex-based differences in psychiatric symptoms and relationships among sex, psychiatric symptoms, and opioid use outcomes in youth with OUD receiving buprenorphine/naloxone (Bup/Nal) and psychosocial treatment. METHODS: The study randomly assigned one hundred and fifty-two youth (15-21 years old) diagnosed with OUD to either 12 weeks of treatment with Bup/Nal or up to 2 weeks of Bup/Nal detoxification with both treatment arms receiving weekly drug counseling as part of a multisite clinical trial (NIDA-CTN-0010). We compared psychiatric symptoms, assessed via the Youth Self Report (YSR) at baseline and week 12, across male and female OUD participants. The study used logistic regression models to identify sex and psychiatric symptom variables that were predictors of opioid positive urine (OPU) at week 12. RESULTS: Compared to males, females with OUD had higher mean psychiatric symptom scores at baseline across broad-band and narrow-band symptom domains. The study observed significant reductions in psychiatric symptom scores in both males and females during treatment, and by week 12, females only differed from males on anxious-depressive symptom scores. Females, in general, and youth of both sexes presenting to treatment with higher anxious depression scores were less likely to have a week-12 OPU. CONCLUSIONS: Clinically significant sex-based differences in psychiatric symptoms are present at baseline among youth with OUD receiving Bup/Nal-assisted treatment and mostly resolve during treatment.

Family involvement in treatment and recovery for substance use disorders among transition-age youth: Research bedrocks and opportunities.

This article presents a narrative review and conceptual framework for research on family involvement across the continuum of substance use disorder (SUD) services for transition-age youth (ages 15-26). Though families are powerful resources for enhancing treatment and recovery success among youth with SUDs, they are not routinely included in clinical practice. This article summarizes youth SUD prevalence and service utilization rates and presents developmental and empirical rationale for increasing family involvement in services. It then describes key research issues on family involvement across the SUD services continuum: Problem Identification, Treatment Engagement, Active Treatment, Recovery Support. Within each phase, it highlights bedrock research findings and suggests promising opportunities for advancing the scientific knowledge base on family involvement. The main goals are to endorse family-oriented practices for immediate adoption in routine care and identify areas of research innovation that could significantly enhance the quality of youth SUD services.

Examination of Correlates of OUD Outcomes in Young Adults: Secondary Analysis From the XBOT Trial.

BACKGROUND AND OBJECTIVES: Opioid use disorder (OUD) treatment outcomes are poorer for young adults than older adults. Developmental differences are broadly implicated, but particular vulnerability factor interactions are poorly understood. This study sought to identify moderators of OUD relapse between age groups. METHODS: This secondary analysis compared young adults (18-25) to older adults (26+) from a comparative effectiveness trial ("XBOT") that randomized (N = 570) participants to extended-release naltrexone or sublingual buprenorphine-naloxone. We explored the relationship between 25 prespecified patient baseline characteristics and relapse to regular opioid use by age group and treatment condition, using logistic regression. RESULTS: Young adults (n = 111) had higher rates of 24-week relapse than older adults (n = 459) (70.3% vs 58.8%) and differed on a number of specific characteristics, including more smokers, more intravenous opioid use, and more cannabis use. No significant moderators predicted relapse, in either three-way or two-way interactions. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: No baseline factors were identified as moderating the relationship between age group and opioid relapse, nor any interactions between baseline characteristics, age group, and treatment condition to predict opioid relapse. Poorer treatment outcomes for young adults are likely associated with multiple developmental vulnerabilities rather than any single predominant factor. Although not reaching significance, several characteristics (using heroin, smoking tobacco, high levels of depression/anxiety, or treatment because of family/friends) showed higher odds ratio point estimates for relapse in young adults than older adults. This is the first study to explore moderators of worse OUD treatment outcomes in young adults, highlighting the need to identify predictor variables that could inform treatment enhancements. (Am J Addict 2021;00:1-12).

Choice of extended release medication for OUD in young adults (buprenorphine or naltrexone): A pilot enhancement of the Youth Opioid Recovery Support (YORS) intervention.

BACKGROUND: The Youth Opioid Recovery Support (YORS) intervention is a promising approach for the treatment of opioid use disorder (OUD) in young adults that seeks to improve adherence to extended-release medications for OUD (XR-MOUD) and reduce opioid relapse through assertive outreach techniques. YORS was previously tested with individuals seeking extended-release naltrexone (XR-NTX), but has not been tested on individuals pursuing extended-release buprenorphine (XR-BUP). METHODS: This pilot study tested the YORS intervention among a group choosing either XR-MOUD compared to historical treatment as usual (H-TAU) and intervention conditions from a previous study. This study also tested feasibility of a stepped care approach using a protocol for transition to standard care. Twenty-two young adults (ages 18-26) with OUD intending to pursue outpatient treatment with XR-NTX (n = 11) or XR-BUP (n = 11) were recruited from inpatient treatment and received 12-24 weeks of the YORS intervention. RESULTS: Participants in YORS compared to H-TAU received more outpatient doses at 12 weeks (1.91 vs. 0.40, p < .001) and 24 weeks (3.76 vs. 0.70, p < .001), had lower relapse rates at 12 weeks (36.4% vs.75.0%; p = .012) and 24 weeks(52.9% vs. 95.0%; p = .003), and had greater cumulative relapse-free survival over 24 weeks (HR = 2.65, 95% CI: 1.17-6.02, p < .05). Rates of continuing MOUD in a standard care setting after the intervention ended were extremely poor. Outcomes did not differ by medication choice. CONCLUSIONS: These results are consistent with previous findings and demonstrate feasibility and efficacy of YORS with patient choice of medication. The results highlight the need for innovative strategies to sustain positive outcomes and step-down care successfully in these vulnerable young adults.

Conceptual framework for telehealth strategies to increase family involvement in treatment and recovery for youth opioid use disorder.

With opioid use at crisis levels, it is imperative to support youth ages with opioid use disorders (OUD) in taking medication and accessing behavioral services over long periods. This article presents a conceptual framework for telehealth strategies that can be adopted to increase family involvement across a four-stage continuum of youth OUD treatment and recovery: Treatment Preparation, Treatment Initiation, Treatment Stabilization, OUD Recovery. It first identifies provider-delivered tele-interventions that can enhance OUD services in each of the four stages, including family outreach, family engagement, family-focused intervention, and family-focused recovery maintenance. It then introduces several types of direct-to-family tele-supports that can be used to supplement provider-delivered interventions. These include both synchronous tele-supports (remote interactions that occur in real time) such as helplines, peer-to-peer coaching, and online support groups; and asynchronous tele-supports (communications that occur without participants being simultaneously present) such as automated text messaging, self-directed internet-based courses, and digital web support.

A pilot randomized controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.

BACKGROUND AND AIMS: Although medications for opioid use disorder (OUD), including extended-release naltrexone (XR-NTX), have demonstrated effectiveness, adherence is often low. We tested the preliminary efficacy of youth opioid recovery support (YORS), a multi-component intervention designed to improve engagement and medication adherence for young adults with OUD. DESIGN: Single-site randomized controlled trial with 24-week follow-up. SETTING: Community substance use disorder treatment program in Baltimore, MD, USA. PARTICIPANTS: Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX. Twenty-one participants were randomized to YORS and 20 to treatment as usual (TAU). The analyzed sample was 65.8% male. INTERVENTION AND COMPARATOR: Components of YORS include: (1) home delivery of XR-NTX; (2) family engagement; (3) assertive outreach; and (4) contingency management for receipt of XR-NTX doses. The comparator was TAU, which consisted of a standard referral to outpatient care following an inpatient stay. MEASUREMENTS: Primary outcomes were number of XR-NTX doses received over 24 weeks and relapse to opioid use (defined as ≥ 10 days of use within 28 days) at 24 weeks. FINDINGS: Participants in the YORS condition received more XR-NTX doses [mean = 4.28; standard deviation (SD) = 2.3] compared with those in TAU (mean = 0.70; SD = 1.2), P < 0.01. Participants in the YORS group compared with TAU had lower rates of relapse (61 versus 95%; P < 0.01). Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition [hazard ratio (HR) = 2.72, 95% confidence interval (CI) = 1.26-5.88, P < 0.01]. CONCLUSIONS: The youth opioid recovery support intervention for extended-release naltrexone adherence and opioid relapse prevention among young adults with opioid use disorder appeared to improve treatment and relapse outcomes compared with standard treatment.

Mobile van delivery of extended-release buprenorphine and extended-release naltrexone for youth with OUD: An adaptation to the COVID-19 emergency.

The Youth Opioid Recovery Support (YORS) intervention is a novel treatment for young adults with opioid use disorder (OUD) that uses developmentally informed strategies to reduce barriers to treatment engagement. YORS strategies, such as home delivery of extended-release buprenorphine and extended-release naltrexone for OUD, are designed to increase engagement in treatment, but with the COVID-19 pandemic these strategies increase risk of virus exposure and spread to patients and staff entering homes. We present mobile van service delivery as a potential solution to continuing to provide low-barrier care for young adults with OUD while reducing risk associated with COVID-19. Initial feedback from patients and staff is positive and lays the groundwork to test feasibility and acceptability of this intervention rigorously in future work. Mobile van delivery of extended-release medications for OUD may be a promising treatment modification for mitigating risk of COVID-19, as well as a useful option for ongoing enhancement of care.

A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.

This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.