Faculty Bibliography

INTRODUCTION/UNASSIGNED:The COVID-19 pandemic had a devastating impact on people who use drugs (PWUD). Reductions in access to harm reduction tools and treatment services elevated rates of fatal overdose for many. We explore the mechanism through which these factors influenced the rise in overdose mortality during COVID-19 from the perspective of people with overdose encounters. METHODS/UNASSIGNED:We conducted in-depth, semi-structured, 60-minute telephone-based interviews with 43 overdose survivors and witnesses between January and May 2022. Participants were from nine states (ME, MI, MD, NJ, NY, NM, PA, TN, WV) and Washington, DC. Data were analyzed thematically following the Continuum of Overdose Risk. RESULTS/UNASSIGNED:Most reported worsening mental health and increasing substance use during COVID-19. Isolation due to quarantining measures, coping behaviors, despair, and traumatic grief contributed to resumptions in drug use and risky behaviors. Some discussed how these stressors, combined with the rapid availability of financial resources led to increased use. Participants also attributed increased overdose risk to the increasingly toxic drug supply and stifled harm reduction access. Accounts of methadone treatment varied, however several expressed inconsistent access to take-home methadone, potentially contributing to resumed use. CONCLUSIONS/UNASSIGNED:Numerous micro- and macro-social factors, as well as the drug supply and treatment disruptions contributed to the acceleration in overdose risk. Increased funding and policy reform are needed to reduce overdose mortality in future public health emergencies, including improving harm reduction and treatment service adaptations to fit the needs of clients, as well as upholding and expanding novel methadone treatment delivery models.

BACKGROUND:Methadone is a highly effective, strictly regulated medication to treat opioid use disorder. COVID-19 flexibilities allowed for up to 28 days of take-homes versus daily travel to clinics for observed dosing, but receiving take-homes differed widely across clinics and individuals. We examined the relationship between state take-home policies and social vulnerability on take-home methadone receipt and days' supply. METHODS:Data were from the VOICES study, a telephone survey conducted between 1/2023-8/2024 of people who use drugs from Wisconsin, Michigan, New Mexico, and New Jersey. We estimated average marginal effects of state methadone policy (flexibility-adoption vs non-adoption) on methadone take-home receipt and days' supply. Models were fully adjusted for individual sociodemographic characteristics. RESULTS:Most participants were recruited from flexibility-adoption states (n = 285/428, 67%). Over half received take-home methadone (65%; average 3.1 days' supply, SD 6.2); 19% of take-home recipients (n = 54) received ≥3 days' supply. Take-home receipt was higher for participants in flexibility-adoption states (AME 0.52, p < 0.0001). Receiving ≥3 days' supply was lower in people reporting unemployment (vs. employment, AME -0.23, p = 0.0032) and past 30-day drug use (vs. no drug use, AME -0.23, p = 0.0014). CONCLUSIONS:State take-home policy was most strongly associated with take-home methadone receipt. Receiving longer days of take-home supplies remains rare. Take-home eligibility guidelines should be established and consider potential social vulnerability factors to daily on-site dosing.

OBJECTIVE:The CDC recommends initiating opioids for pain treatment at the lowest effective dose and duration. We examine how interactions between dose, duration, and other medication factors (e.g., drug type) influence opioid use disorder (OUD) risk-a gap not considered by CDC guidelines. SUBJECTS/METHODS:Using Medicaid claims data (2016-2019) from 25 states, we analyzed opioid-naïve adults, newly diagnosed with musculoskeletal pain who initiated opioids within three months of diagnosis. A 6-month washout confirmed no prior opioid exposure or musculoskeletal diagnosis. METHODS:Initial opioids were categorized by "dose-days supplied" (low [>0-20 mg MME] to very high [>90 mg MME] dose, and short [1-7 days] to moderate [>7-30 days] supply), and by opioid type; physical therapy (PT) sessions were also recorded. Using Poisson regression models, we estimated the OUD risk associated with dose-days categories, adjusting for baseline demographics, clinical characteristics, and medications. We separately examined opioid dose-days and PT, and assessed PT's moderating effect on dose-days' impact. RESULTS:Among 30,536 patients, half initiated opioids at 20-50 MME for 1-7 days, and 20% received PT. OUD risk was 2-3 times higher for opioids initiated for >7-30 days compared to 1-7 days across doses, and 5.5 times higher for opioids initiated for >7-30 days at > 90 MME versus 1-7 days at < 20 MME. PT alone, neither affected OUD risk nor mitigated the increased risk from longer or higher-dose opioids. CONCLUSIONS:Our findings support the need for careful opioid prescribing and alternative pain management strategies, as the observed associations between initial prescription characteristics and OUD were not mitigated by adjunctive PT. PERSPECTIVE/CONCLUSIONS:This study demonstrated that initial opioid prescriptions of 7-30 days, especially above 90 MME/day, increased OUD risk in opioid-naïve patients with musculoskeletal pain; physical therapy did not mitigate the risk. Different opioids posed varied risks, even at the same dose and duration. Careful prescribing and alternative pain management are essential.

BACKGROUND:Practical and motivational barriers can deter people from engaging in substance use disorder (SUD) treatment, even those who seek treatment. Care navigation is a psychosocial intervention that seeks to facilitate patients' timely access to care by identifying and intervening upon barriers. Few trials have tested the effectiveness of care navigation when embedding in real-world healthcare, and no trials have studied the process of implementing care navigation into clinical practice. This protocol describes a study that will evaluate whether care navigation can increase treatment engagement among patients seeking SUD treatment. METHODS:The Addressing Barriers to Care for Substance Use Disorder (ABC-SUD) study is a hybrid type I cluster-randomized effectiveness-implementation trial. It is conducted in a mental health access center of an integrated healthcare system in Washington state. Within this center, licensed mental health clinicians assess patient needs and use shared decision-making to establish SUD treatment plans for patients (usual care). This study tests whether an added care navigation intervention can improve patient engagement in SUD treatment. Care navigation begins after a treatment plan is made and provides up to 7 weeks of support focused on enhancing patient motivation to initiate and engage in treatment, problem-solving barriers (e.g., transportation logistics), and accommodating patient preferences (e.g., preferred language of care, cultural preferences). This trial uses a two period, two sequence crossover design. Clinicians are randomized to offer care navigation to patients during the first or second study period (i.e., clinicians are assigned to an initial study condition and switch conditions halfway through the trial). Care navigation is implemented with several strategies: leadership engagement, clinical workflow specifications, electronic health record (EHR) tools, training, performance improvement, and electronic learning collaborative. The primary outcome-obtained from EHRs and insurance claims-is engagement in SUD treatment, defined as ≥3 SUD treatment visits within 48 days of a treatment plan. This study uses standardized measures of implementation climate and outcomes to examine mechanisms with which the intervention strategies exert their impact on implementation and effectiveness outcomes. DISCUSSION/CONCLUSIONS:The ABC-SUD study will test whether care navigation improves SUD treatment engagement while concurrently generating information about its implementation in healthcare. TRIAL REGISTRATION/BACKGROUND:This study was prospectively registered at www. CLINICALTRIALS/RESULTS:gov (NCT06729957) on December 9, 2024.

INTRODUCTION/BACKGROUND:In Latin America and the Caribbean (LAC) the response to substance use has primarily been abstinence-based, acute-care-oriented treatments. While harm reduction services (HRS) and interventions have expanded in LAC over the last decade, the research evidence on such programs has been sparse and disjointed. OBJECTIVE:This scoping review will map peer-reviewed literature on HRS and interventions in LAC, and synthesize gaps and opportunities for policy, practice, and research. INCLUSION CRITERIA/METHODS:Studies conducted in LAC. The HRS that will be included in the search are opioid agonist therapy, syringe services programs, drug consumption facilities, safer consumption kits, managed alcohol programs, and drug-checking services. The scoping review will consider peer-reviewed original research, including qualitative, quantitative, and mixed-methods designs. We will exclude studies addressing harms associated with nicotine or tobacco use. We included original research written in English, Spanish, Portuguese, or French published between January 2013 and December 2024. METHODS:We will conduct literature searches in English (PubMed, Scopus, Web of Science), Spanish, Portuguese (SciELO and BIREME), and French (BIREME). Two reviewers will independently screen the literature. Extraction of characteristics of the studies using a template in Covidence. Data on the HRS and interventions studied and implemented in LAC will be summarized and presented in tables, graphs, and a narrative summary. We will use a narrative synthesis approach to summarize implications for policy, research, and practice identified in the literature. The review was registered in Open Science Framework (https://osf.io/qya7c/). DISCUSSION/CONCLUSIONS:The proposed scoping review will provide valuable information regarding the current state of HRS and interventions for PWUD in LAC. This in return can help guide future research for evaluating services that are already being implemented or unveil services needed in the region. To our knowledge, this is the first scoping review to map HRS in LAC using a systematic approach. Furthermore, among the strengths of this review are: the broad number of services, countries, and time, as well as the consultation with experts and knowledge users.

Methadone treatment (MT) for opioid use disorder saves lives, but the US MT system has long been dominated by punitive policies and practices that make MT inaccessible, burdensome, and traumatic for patients. After generations without changes to methadone regulations, a confluence of circumstance-including the COVID-19 pandemic and an overdose crisis that has taken over a million lives-has begun to shift the MT advocacy and political landscape. This commentary describes the building of the "Liberate Methadone" movement; a grassroots effort led by people with lived and living experience with methadone, addiction clinicians, researchers, community leaders, and people with many of these identities. The Liberate Methadone movement is dedicated to building a more accessible, equitable MT system that prioritizes patient health, promotes dignity, and is grounded in evidence. We describe the experience of planning and hosting a national conference and generating proceedings with recommendations for needed incremental and structural reforms within the US MT system. The lessons learned from this movement can motivate others across clinical, research, and policy roles to partner with and learn from patient and community-led groups, guiding needed reforms within systems of care. It is through these joint efforts and listening to those directly impacted groups who have been left out of the conversation for far too long, that we can successfully reduce overdose and suffering, toward better health, dignity, and thriving in our communities.

BACKGROUND:Take-home methadone (THM) flexibility has increased since 2020, representing innovation in opioid use disorder treatment. There are no established approaches to measuring THM using insurance claims data. We proposed and validated candidate measures of THM. METHODS:Using 2020 Medicaid data from 4 states, we constructed treatment episodes for enrollees aged 18-64. Episodes started after July 1, 2020 and lasted at least 60 days. We labelled individuals as receiving THM if they received ≥6 consecutive days of THM in their 2nd month of treatment, as defined by presence of claims with a modifier code indicating THM (the "gold-standard" indicator). We defined 4 candidate indicators of THM based on intervals between in-clinic methadone administrations. We assessed performance of each candidate indicator against the gold-standard. We assessed the extent to which between-program variation explained total variation in measured THM. RESULTS:The study sample included 4836 episodes for 4801 individuals. THM was present in 14 % of episodes. Sensitivity of candidate indicators ranged from 65 to 100 %, with the most sensitive being an indicator that was true if any two adjacent in-clinic service dates had a gap of ≥7 days. Specificity ranged from 80 to 96 %, with the most specific measure being one requiring 2 consecutive intervals of ≥7 days that were of the same length. Between-program variation explained 38.6-48.3 % of variation in THM receipt. CONCLUSIONS:Two indicators of THM using Medicaid data presented excellent performance when evaluated against a gold-standard indicator. Our approach can be used to assess uptake and outcomes of THM.

Amid the ongoing overdose crisis, U.S. lawmakers are considering policy reforms that could significantly change availability and accessibility of methadone treatment (MT) for opioid use disorder (OUD). However, uncertainty remains about which potential changes will lead to the greatest health benefits while minimizing unintended harms. In this protocol, we describe a planned NIH-funded study (R21DA061660) to simulate alternative MT delivery scenarios currently being considered in U.S. policy discussions, and estimate their impact on population-level rates of treatment initiation and retention and opioid overdose across different sociodemographic groups. We will use an agent-based model focused on 16 counties in NY State to simulate two alternative policy scenarios compared to the current status quo of opioid-treatment program (OTP) delivered MT: 1) office-based prescribing by addiction-certified providers with pharmacy and OTP dispensing; and 2) office-based prescribing by general practitioners with pharmacy and OTP dispensing. Agents will represent individuals with OUD and we will simulate access to MT based on alternative policy scenarios (e.g., locations of existing OTPs vs. provider offices and pharmacies). Probabilities of treatment initiation, retention, and opioid overdose will be informed by estimates from the scientific literature and administrative datasets from NY State. Multiple implementation scenarios will be considered to account for potential variation in adoption of office-based methadone by patients, providers, and pharmacies. To ensure relevance to directly impacted communities and policy makers, the study involves a collaboration between academic researchers and NY State government partners and relies on input from an Expert Advisory Board of people with lived and living experience with methadone, addiction medicine, and policy experts. Findings will be disseminated via a public dashboard. This study will inform ongoing policy discussions and shed light on the potential of researcher-policy partnerships to promote evidence-based policies that can reduce overdose and improve population health.