Brief Parent-Child Substance Use Education Intervention for Black Families in Urban Cities in New Jersey: Protocol for a Formative Study Design.

BACKGROUND: Substance use continues to remain a public health issue for youths in the United States. Black youths living in urban communities are at a heightened risk of poor outcomes associated with substance use and misuse due to exposure to stressors in their neighborhoods, racial discrimination, and lack of prevention education programs specifically targeting Black youths. Many Black youths, especially those who live in urban communities, do not have access to culturally tailored interventions, leaving a critical gap in prevention. Since family is a well-known protective factor against substance misuse for Black youths, it is essential to create sustainable and accessible programming that incorporates Black youths' and their families' voices to develop a suitable prevention program for them. OBJECTIVE: We aim to understand the cultural and environmental level factors that influence substance use among Black youths and develop a prevention program to increase parent-child substance use education among Black families. METHODS: This study will take place within urban cities in New Jersey such as Paterson and East Orange, New Jersey, which will be the main study sites. Both cities have a large population of Black youths and this study's team has strong ties with youths-serving organizations there. A formative, qualitative study will be conducted first. Using the first 3 steps of the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, and Testing) framework we begin the development of an intervention for Black families. Three aims will be described: aim 1, collect qualitative data from Black parents and youths aged 11-17 years from parent-child dyads (N=20) on the challenges, barriers, and facilitators to communicating about substance use; aim 2, adapt a selected evidence-based intervention for Black families and develop a family advisory board to guide the adaptation; and aim 3 assess the feasibility of the intervention through theater testing, involving the family and community advisory board. RESULTS: This study is part of a 2-year research pilot study award from the National Institutes of Drug Abuse. Data collection began in May 2023, and for aim 1, it is 95% complete. All aim 1 data collection is expected to be complete by December 30, 2023. Data analysis will immediately follow. Aim 2 activity will occur in spring 2024. Aim 3 activity may begin in fall 2024 and conclude in 2025. CONCLUSIONS: This study will be one of the few interventions that address substance use among youths and uses parents and families in urban communities as a protective factor within the program. We anticipate that the intervention will benefit Black youths not only in New Jersey but across the nation, working on building culturally appropriate, community-specific prevention education and building on strong families' relationships, resulting in a reduction of or delayed substance use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55470.

'Everywhere I call, there's nothing available': Understanding the alcohol treatment landscape and needs among unstably housed people who use alcohol in Rhode Island.

INTRODUCTION: Alcohol is a leading cause of morbidity and mortality in the United States and people who are unstably housed are disproportionately impacted by adverse alcohol-related health outcomes. Addressing the needs of unstably housed people with high-intensity alcohol use (i.e., heavy episodic use or binge drinking), including those whose goal is not abstinence, is critical to reducing harms among this population. This study explores the alcohol-related treatment and support needs among unstably housed people who use alcohol. METHODS: Data collection included participant observation and semi-structured interviews (n = 25) with unstably housed people with high-intensity alcohol use. Data were analysed thematically, with attention to structural vulnerability and social-structural forces at shaping perceptions of and experiences with alcohol treatment. RESULTS: Participants underscored how housing instability was critical in precipitating and maintaining heavy alcohol use, with alcohol often used to manage the stress and anxiety related to housing instability. While participants regularly engaged with alcohol treatment programs, program design and barriers to access undermined the effectiveness of these services for participants. Participants described the need for a range of program and service options across a continuum of care to be implemented to support participants in meeting their diverse needs and identified goals regarding alcohol use. DISCUSSION AND CONCLUSIONS: Alcohol treatment and supports need to be modified so that they include a range of harm reduction and abstinence-based models to better meet people's diverse needs. Furthermore, treatment must be paired with permanent and affordable housing to address underlying drivers of alcohol-related harm for unstably housed people.

Dual fluorescence reporter mice for Ccl3 transcription, translation, and intercellular communication.

Chemokines guide immune cells during their response against pathogens and tumors. Various techniques exist to determine chemokine production, but none to identify cells that directly sense chemokines in vivo. We have generated CCL3-EASER (ErAse, SEnd, Receive) mice that simultaneously report for Ccl3 transcription and translation, allow identifying Ccl3-sensing cells, and permit inducible deletion of Ccl3-producing cells. We infected these mice with murine cytomegalovirus (mCMV), where Ccl3 and NK cells are critical defense mediators. We found that NK cells transcribed Ccl3 already in homeostasis, but Ccl3 translation required type I interferon signaling in infected organs during early infection. NK cells were both the principal Ccl3 producers and sensors of Ccl3, indicating auto/paracrine communication that amplified NK cell response, and this was essential for the early defense against mCMV. CCL3-EASER mice represent the prototype of a new class of dual fluorescence reporter mice for analyzing cellular communication via chemokines, which may be applied also to other chemokines and disease models.

Provider perceptions of systems-level barriers and facilitators to utilizing family-based treatment approaches in adolescent and young adult opioid use disorder treatment.

BACKGROUND: Amidst increasing opioid-related fatalities in adolescents and young adults (AYA), there is an urgent need to enhance the quality and availability of developmentally appropriate, evidence-based treatments for opioid use disorder (OUD) and improve youth engagement in treatment. Involving families in treatment planning and therapy augments medication-based OUD treatment for AYA by increasing treatment engagement and retention. Yet, uptake of family-involved treatment for OUD remains low. This study examined systems-level barriers and facilitators to integrating families in AYA OUD treatment in Rhode Island. METHODS: An online survey was administered to clinic leaders and direct care providers who work with AYA in programs that provide medication and psychosocial treatments for OUD. The survey assessed attitudes towards and experiences with family-based treatment, barriers and facilitators to family-based treatment utilization, as well as other available treatment services for AYA and family members. Findings were summarized using descriptive statistics. RESULTS: A total of 104 respondents from 14 distinct treatment programs completed the survey. Most identified as White (72.5%), female (72.7%), and between 25 and 44 years of age (59.4%). Over half (54.1%) of respondents reported no experience with family based treatment and limited current opportunities to involve families. Barriers perceived as most impactful to adopting family-based treatment were related to limited available resources (i.e. for staff training, program expansion) and lack of prioritization of family-based treatment in staff productivity requirements. Barriers perceived as least impactful were respondent beliefs and attitudes about family-based treatment (e.g., perception of the evidence strength and quality of family-based treatment, interest in implementing family-based treatment) as well as leadership support of family-based treatment approaches. Respondents identified several other gaps in availability of comprehensive treatment services, especially for adolescents (e.g. services that increase social recovery capital). CONCLUSIONS: Family-based treatment opportunities for AYA with OUD in Rhode Island are limited. Affordable and accessible training programs are needed to increase provider familiarity and competency with family-based treatment. Implementation of programming to increase family involvement in treatment (i.e. psychoeducational and skills-based groups for family members) rather than adopting a family-based treatment model may be a more feasible step to better meet the needs of AYA with OUD. TRIAL REGISTRATION: not applicable.

What do you think it means? Using cognitive interviewing to improve measurement in implementation science: description and case example.

Pragmatic measures are essential to evaluate the implementation of evidence-based interventions. Cognitive interviewing, a qualitative method that collects partner feedback throughout measure development, is particularly useful for developing pragmatic implementation measures. Measure developers can use cognitive interviewing to increase a measure's fit within a particular implementation context. However, cognitive interviewing is underused in implementation research, where most measures remain "homegrown" and used for single studies. We provide a rationale for using cognitive interviewing in implementation science studies and illustrate its use through a case example employing cognitive interviewing to inform development of a measurement-based care protocol for implementation in opioid treatment programs. Applications of cognitive interviewing, including developing a common language with partners and collecting multi-level feedback on assessment procedures, to improve measurement in implementation science are discussed.

The "D&I Bridge": introducing a teaching tool to define the D, the I, and the why.

Interest in learning dissemination and implementation (D&I) science is at an all-time high. As founding faculty and fellows of a new center focused on D&I science, we have found that non-specialist researchers and newcomers to D&I science often express confusion around the difference between the D and the I. Relatedly, they struggle to identify what their specific D&I projects target to impact public health within the amorphous "black box" that is the singular, loosely defined "research-to-practice gap." To improve conceptual clarity and enhance engagement with D&I science, we developed a graphic-the D&I Bridge-and an accompanying glossary of terms to use as a teaching and framing tool. The D&I Bridge depicts D&I science as bridging what we know from public health knowledge to what we do in public health practice with intention and equity, and it spans over four distinct, inter-related gaps: the public health supply gap, the public health demand gap, the methodological/scientific gap, and the expertise capacity gap. The public health supply gap is addressed by implementation strategies, whereas the public health demand gap is addressed by dissemination strategies. The methodological/scientific gap is addressed by producing generalizable knowledge about D&I, and the expertise capacity gap is addressed by developing the multi-disciplinary workforce needed to advance D&I. Initial practice feedback about the D&I Bridge has been positive, and this conceptualization of D&I science has helped inform our center's D&I training, D&I project consultations, and strategic planning. We believe the D&I Bridge provides a useful heuristic for helping non-specialists understand the differential scopes of various D&I science projects as well as specific gaps that may be addressed by D&I methods.

Characterizing opioid overdose hotspots for place-based overdose prevention and treatment interventions: A geo-spatial analysis of Rhode Island, USA.

OBJECTIVE: Examine differences in neighborhood characteristics and services between overdose hotspot and non-hotspot neighborhoods and identify neighborhood-level population factors associated with increased overdose incidence. METHODS: We conducted a population-based retrospective analysis of Rhode Island, USA residents who had a fatal or non-fatal overdose from 2016 to 2020 using an environmental scan and data from Rhode Island emergency medical services, State Unintentional Drug Overdose Reporting System, and the American Community Survey. We conducted a spatial scan via SaTScan to identify non-fatal and fatal overdose hotspots and compared the characteristics of hotspot and non-hotspot neighborhoods. We identified associations between census block group-level characteristics using a Besag-York-Mollié model specification with a conditional autoregressive spatial random effect. RESULTS: We identified 7 non-fatal and 3 fatal overdose hotspots in Rhode Island during the study period. Hotspot neighborhoods had higher proportions of Black and Latino/a residents, renter-occupied housing, vacant housing, unemployment, and cost-burdened households. A higher proportion of hotspot neighborhoods had a religious organization, a health center, or a police station. Non-fatal overdose risk increased in a dose responsive manner with increasing proportions of residents living in poverty. There was increased relative risk of non-fatal and fatal overdoses in neighborhoods with crowded housing above the mean (RR 1.19 [95 % CI 1.05, 1.34]; RR 1.21 [95 % CI 1.18, 1.38], respectively). CONCLUSION: Neighborhoods with increased prevalence of housing instability and poverty are at highest risk of overdose. The high availability of social services in overdose hotspots presents an opportunity to work with established organizations to prevent overdose deaths.

Psychometric properties of the family assessment task parental monitoring scenario among adolescents receiving substance use treatment.

INTRODUCTION: The Family Assessment Task (FAsTask) is an observer-rated parent-child interaction task used in adolescent substance use intervention. The parental monitoring component of the FAsTask is thought to provide an objective assessment of parental monitoring that can guide treatment planning and circumvent the potential limitations of self-report measures. Yet, the factor structure, measurement invariance, and concurrent validity of the parental monitoring FAsTask has not been evaluated; doing so is essential to effectively guide clinical care. This study examined if the parental monitoring FAsTask can be reliably administered across adolescent age and sex, and to identify which components of the parental monitoring FAsTask are most consistently associated with adolescent substance use. METHODS: The study pooled data from 388 adolescent-caregiver dyads across six separate clinical trials (adolescents [Mage = 15.7, 57.5% male, 61.9% White, 31.2% Latine]; caregivers [Mage = 42.14, 88.7% female, 72.7% White, 24.2% Latine]). Dyads completed the FAsTask and the Timeline Followback at baseline, prior to randomization. Analyses proceeded in three steps. First, exploratory factor analysis (EFA) was conducted in half of the sample, followed by a confirmatory factor analysis (CFA) in the second half of the sample. Second, measurement invariance was tested as a function of adolescent age and biological sex. Third, a series of structural equation models were used to assess the associations of each factor with alcohol use, binge drinking, and cannabis use. RESULTS: EFA and CFA indicated the presence of four factors (labeled Supervised/Structured, Active Monitoring, Task Engagement, and Parental Rules/Strategies). Evidence of measurement invariance was found across adolescent age and sex. The Supervision/Structure was negatively associated with adolescent alcohol use, binge drinking, and cannabis use. CONCLUSIONS: The parental monitoring FAsTask demonstrates validity and retains its structure across adolescent age and sex. Items focused on parental supervision and structure are most strongly associated with adolescent substance use and may best inform clinical care for adolescent substance use.

Vascular Burden Moderates the Relationship Between ADHD and Cognition in Older Adults.

OBJECTIVES: Recent evidence suggests attention-deficit/hyperactivity disorder (ADHD) is a risk factor for cognitive impairment in later life. Here, we investigated cerebrovascular burden, quantified using white matter hyperintensity (WMH) volumes, as a potential mediator of this relationship. DESIGN: This was a cross-sectional observational study. SETTING: Participants were recruited from a cognitive neurology clinic where they had been referred for cognitive assessment, or from the community. PARTICIPANTS: Thirty-nine older adults with clinical ADHD and 50 age- and gender-matched older adults without ADHD. MEASUREMENTS: A semiautomated structural MRI pipeline was used to quantify periventricular (pWMH) and deep WMH (dWMH) volumes. Cognition was measured using standardized tests of memory, processing speed, visuo-construction, language, and executive functioning. Mediation models, adjusted for sex, were built to test the hypothesis that ADHD status exerts a deleterious impact on cognitive performance via WMH burden. RESULTS: Results did not support a mediated effect of ADHD on cognition. Post hoc inspection of the data rather suggested a moderated effect, which was investigated as an a posteriori hypothesis. These results revealed a significant moderating effect of WMH on the relationship between ADHD memory, speed, and executive functioning, wherein ADHD was negatively associated with cognition at high and medium levels of WMH, but not when WMH volumes were low. CONCLUSIONS: ADHD increases older adults' susceptibility to the deleterious cognitive effects of WMH in the brain. Older adults with ADHD may be at risk for cognitive impairment if they have deep WMH volumes above 61 mm3 and periventricular WMH above 260 mm3.

Direct antigen presentation is the canonical pathway of cytomegalovirus CD8 T-cell priming regulated by balanced immune evasion ensuring a strong antiviral response.

CD8 T cells are important antiviral effectors in the adaptive immune response to cytomegaloviruses (CMV). Naïve CD8 T cells can be primed by professional antigen-presenting cells (pAPCs) alternatively by "direct antigen presentation" or "antigen cross-presentation". In the case of direct antigen presentation, viral proteins are expressed in infected pAPCs and enter the classical MHC class-I (MHC-I) pathway of antigen processing and presentation of antigenic peptides. In the alternative pathway of antigen cross-presentation, viral antigenic material derived from infected cells of principally any cell type is taken up by uninfected pAPCs and eventually also fed into the MHC class-I pathway. A fundamental difference, which can be used to distinguish between these two mechanisms, is the fact that viral immune evasion proteins that interfere with the cell surface trafficking of peptide-loaded MHC-I (pMHC-I) complexes are absent in cross-presenting uninfected pAPCs. Murine cytomegalovirus (mCMV) models designed to disrupt either of the two presentation pathways revealed that both are possible in principle and can substitute each other. Overall, however, the majority of evidence has led to current opinion favoring cross-presentation as the canonical pathway. To study priming in the normal host genetically competent in both antigen presentation pathways, we took the novel approach of enhancing or inhibiting direct antigen presentation by using recombinant viruses lacking or overexpressing a key mCMV immune evasion protein. Against any prediction, the strongest CD8 T-cell response was elicited under the condition of intermediate direct antigen presentation, as it exists for wild-type virus, whereas the extremes of enhanced or inhibited direct antigen presentation resulted in an identical and weaker response. Our findings are explained by direct antigen presentation combined with a negative feedback regulation exerted by the newly primed antiviral effector CD8 T cells. This insight sheds a completely new light on the acquisition of viral immune evasion genes during virus-host co-evolution.

Immunotherapy of cytomegalovirus infection by low-dose adoptive transfer of antiviral CD8 T cells relies on substantial post-transfer expansion of central memory cells but not effector-memory cells.

Cytomegaloviruses (CMVs) are host species-specific in their replication. It is a hallmark of all CMVs that productive primary infection is controlled by concerted innate and adaptive immune responses in the immunocompetent host. As a result, the infection usually passes without overt clinical symptoms and develops into latent infection, referred to as "latency". During latency, the virus is maintained in a non-replicative state from which it can reactivate to productive infection under conditions of waning immune surveillance. In contrast, infection of an immunocompromised host causes CMV disease with viral multiple-organ histopathology resulting in organ failure. Primary or reactivated CMV infection of hematopoietic cell transplantation (HCT) recipients in a "window of risk" between therapeutic hemato-ablative leukemia therapy and immune system reconstitution remains a clinical challenge. Studies in the mouse model of experimental HCT and infection with murine CMV (mCMV), followed by clinical trials in HCT patients with human CMV (hCMV) reactivation, have revealed a protective function of virus-specific CD8 T cells upon adoptive cell transfer (AT). Memory CD8 T cells derived from latently infected hosts are a favored source for immunotherapy by AT. Strikingly low numbers of these cells were found to prevent CMV disease, suggesting either an immediate effector function of few transferred cells or a clonal expansion generating high numbers of effector cells. In the murine model, the memory population consists of resting central memory T cells (TCM), as well as of conventional effector-memory T cells (cTEM) and inflationary effector-memory T cells (iTEM). iTEM increase in numbers over time in the latently infected host, a phenomenon known as 'memory inflation' (MI). They thus appeared to be a promising source for use in immunotherapy. However, we show here that iTEM contribute little to the control of infection after AT, which relies almost entirely on superior proliferative potential of TCM.

Amplifying consumers as partners in dissemination and implementation science and practice.

Background: This Viewpoint argues for consumers (people with lived experience and their families) to be amplified as key partners in dissemination and implementation science and practice. Method: We contend that consumer opinion and consumer demand can be harnessed to influence practitioners and policymakers. Results: Amplifying consumers' voices can improve the fit of evidence-based interventions to the intended end user. We offer recommendations of frameworks to engage consumers in the dissemination and implementation of health interventions. We discuss the primary types of evidence consumers may rely upon, including testimonials and lived experience. Conclusions: Our intention is for this Viewpoint to continue the momentum in dissemination and implementation science and practice of engaging consumers in our work.

Dissemination and implementation science has insufficiently acknowledged the importance of consumers (people with lived experience and their families) as partners in implementation initiatives. In this viewpoint, we highlight the role consumer opinion can play in influencing practitioners' and policymakers' decisions to sustainably implement evidence-based practices. We encourage implementation researchers and practitioners to solicit and respond to consumer perspectives during their implementation efforts.

Integrating long-acting injectable treatment to improve medication adherence among persons living with HIV and opioid use disorder: study protocol.

BACKGROUND: Oral antiretroviral therapy (ART) has been effective at reducing mortality rates of people with HIV. However, despite its effectiveness, people who use drugs face barriers to maintaining ART adherence. Receipt of opioid agonist treatment, in the context of HIV care, is associated with medication adherence and decreased HIV viral loads. Recent pharmacological advancements have led to the development of novel long-acting, injectable, medications for both HIV (cabotegravir co-administered with rilpivirine) and OUD (extended-release buprenorphine). These therapies have the potential to dramatically improve adherence by eliminating the need for daily pill-taking. Despite the extensive evidence base supporting long-acting injectable medications for both HIV and OUD, and clinical guidelines supporting integrated care provision, currently little is known about how these medications may be optimally delivered to this population. This paper presents the study design for the development of a clinical protocol to guide the delivery of combined treatment for HIV and OUD using long-acting injectable medications. METHODS: The study aims are to: (1) develop a clinical protocol to guide the delivery of combined LAI for HIV and OUD by conducting in-depth interviews with prospective patients, clinical content experts, and other key stakeholders; and (2) conduct This single group, open pilot trial protocol to assess feasibility, acceptability, and safety among patients diagnosed with HIV and OUD. Throughout all phases of the study, information on patient-, provider-, and organizational-level variables will be collected to inform future implementation. DISCUSSION: Findings from this study will inform the development of a future study to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation design.

Counseling for opioids prescribed at discharge of hospitalized adolescent trauma patients.

BACKGROUND: Expert consensus recommends prescription opioid safety counseling be provided when prescribing an opioid. This may be especially important for youth with preexistent alcohol and other drug (AOD) use who are at higher risk of developing opioid use disorder. This study examined the frequency that adolescent trauma patients prescribed opioids at hospital discharge received counseling and if this differed by adolescents' AOD use. METHOD: This study was embedded within a larger prospective stepped-wedge type III hybrid implementation study of AOD screening across a national cohort of pediatric trauma centers. Data were collected during 2018-2021 from admitted adolescent trauma patients (12-17 yo) at seven centers. Patient data were extracted from the electronic health record (EHR) on any prescribed discharged opioids, documentation of counseling delivered on prescribed opioid, who delivered counseling, and patients' AOD screening results. Additionally, adolescents received an online survey within 30 days of hospital discharge that included asking about hospital discussions on safe use of prescription pain medication. RESULTS: Of the 247 adolescent trauma patients enrolled, 158 completed the 30-day survey. AOD screening results were documented in the EHR for 139 patients (88%), with 69 (44.1%) screening AOD-positive. Opioids at discharge were prescribed to 86 (54.4%) adolescent patients, with no significant difference between those screened AOD-positive and AOD-negative (42.4% vs. 46.3%, p = 0.89). Counseling was documented in the EHR for 30 (34.9%) of those prescribed an opioid and was not significantly different by sex, age, race, ethnicity or between adolescent patients with documentation of AOD use (29.3%) versus those who did not (33.3%, p = 0.71). According to the adolescent survey, among those prescribed an opioid, 61.2% reported someone had talked with them about safe use of newly prescribed pain medications with again no difference between AOD-positive and AOD-negative screening results (p = 0.34). CONCLUSIONS: Although adolescent trauma patients recalled discussions on safe use of prescribed pain medication more often than was documented in the EHR, these discussions were not universal and did not differ if adolescents had screened positive or negative for AOD use as documented in the EHR. TRIAL REGISTRY: clinicaltrials.gov NCT03297060.

Risk of neurodegenerative disease or dementia in adults with attention-deficit/hyperactivity disorder: a systematic review.

Purpose of review: Several psychiatric disorders have been associated with an increased risk of developing a neurodegenerative disease and/or dementia. Attention-deficit/hyperactivity disorder (ADHD), a neurodevelopmental disorder, has been understudied in relation to dementia risk. We summarized existing literature investigating the risk of incident neurodegenerative disease or dementia associated with ADHD. Recent findings: We searched five databases for cohort, case-control, and clinical trial studies investigating associations between ADHD and neurodegenerative diseases/dementia in May 2023. Study characteristics were extracted by two independent raters, and risk of bias was assessed using the Newcastle Ottawa Scale. Search terms yielded 2,137 articles, and seven studies (five cohort and two case-control studies) ultimately met inclusion criteria. Studies examined the following types of neurodegeneration: all-cause dementia, Alzheimer's disease, Parkinson's and Lewy body diseases, vascular dementia, and mild cognitive impairment. Heterogeneity in study methodology, particularly covariates used in analyses and types of ratios for risk reported, prevented a meta-analysis and data were therefore summarized as a narrative synthesis. The majority of studies (4/7) demonstrated an overall low risk of bias. Summary: The current literature on risk of developing a neurodegenerative disease in ADHD is limited. Although the studies identified present evidence for a link between ADHD and subsequent development of dementia, the magnitude of the direct effect of ADHD on neurodegeneration is yet to be determined and better empirically designed studies are first needed. Furthermore, the mechanism of how or why ADHD is associated with an increased risk of developing a neurocognitive disorder is still unclear and should be explored in future studies. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022348976, the PROSPERO number is CRD42022348976.

Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial.

BACKGROUND: Contingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim). METHODS: Utilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2-3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints. DISCUSSION: Between planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol. TRIAL REGISTRATION: This study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.

Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial.

BACKGROUND: Opioid overdoses have continued to increase since the start of the COVID-19 pandemic. The pathways through which the COVID-19 pandemic has affected trajectories of opioid use and opioid-related problems are largely unknown. Using the Epidemic-Pandemic Impacts Inventory (EPII), a novel instrument that assess pandemic-related impacts across multiple life domains, we tested the hypothesis that COVID-related impacts (on e.g., interpersonal conflict, employment, infection exposure, and emotional health) experienced in the early months of the pandemic would predict changes in opioid use and opioid-related problems at follow-up. METHODS: This analysis was embedded within a cluster randomized type 3 implementation-effectiveness hybrid trial that had enrolled 188 patients across eight opioid treatments prior to the start of the pandemic. Participants had all been recently inducted on medication for opioid use disorder and were actively receiving treatment. Participants reported on their opioid use and opioid-related problems at baseline and 3-, 6-, and 9-month post-baseline assessments. Between May and August 2020, participants were sent an optional invitation to complete the EPII. RESULTS: One hundred thirty-three respondents completed the EPII and 129 had sufficient data to analyze the EPII and at least one subsequent follow-up. In logistic and zero-inflated negative binomial analyses adjusting for covariates, each endorsed pandemic impact in the interpersonal conflict domain was associated with 67% increased odds of endorsement of any opioid use, and each impact in the employment and infection exposure-domains was associated with 25% and 75% increases in number of endorsed opioid-related problems, respectively. CONCLUSIONS: Mitigating the effect of the pandemic on patients' interpersonal relationships and employment, and promoting greater infection control in opioid treatment programs, could be protective against negative opioid-related outcomes. Trial registration The present study describes secondary data analysis on a previously registered clinical trial: clinicaltrials.gov/ct2/show/NCT03931174.

Examining Changes in Pain Interference via Pandemic-Induced Isolation Among Patients Receiving Medication for Opioid Use Disorder: A Secondary Data Analysis.

Background: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. Methods: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. Results: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. Conclusions: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life.