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Implementation Evaluation of a Multicomponent Intervention to Address the Infectious Disease and Overdose Syndemic Among People Who Use Drugs in Rural Settings

Pho, Mai T; Prusaczyk, Beth; Almirol, Ellen; Fletcher, Scott; Nicholson, William; Ezell, Jerel M; Walters, Suzan M; Augustine, Erin; Bolinski, Rebecca R; Bresett, John; Miller, Kyle; Vanham, Brent; Schneider, John A; Kolak, Marynia A; Friedman, Samuel R; Ouellet, Lawrence J; Salisbury-Afshar, Elizabeth; Lee, Karen; Tilmon, Sandra; Johnson, Daniel; Sattovia, Stacy; Han, Heeyoung; Fraase, Karen; Jenkins, Wiley D
OBJECTIVE:To evaluate the effectiveness and implementation of a multicomponent intervention to address the burden of drug use-related infectious diseases and overdose in rural settings. DESIGN/METHODS:Single-arm hybrid implementation-effectiveness design. SETTING/METHODS:Rural area comprising the Illinois counties of the Delta Regional Authority. PARTICIPANTS/METHODS:People who use opioids and/or stimulants nonmedically. INTERVENTION/METHODS:Expansion of community-based harm reduction services, capacity-building for opioid use disorder and hepatitis C treatment. MAIN OUTCOME MEASURES/METHODS:Harm reduction service expansion intervention Reach, Effectiveness (injection equipment sharing), Adoption and Cost (per participant and budget impact analysis). RESULTS:Three hundred six people who use drugs were enrolled. Of the 207 of who were not previously engaged in harm reduction services, 121 (59%) accepted referral and were retained in services at 6 months past study enrollment (intervention reach). In regards to intervention efficacy, among these individuals, 41 (35%) completed follow-up surveys; compared with their baseline self-report, there was a significant increase in obtaining sterile equipment from the harm reduction organization (43.9% vs. 68.3%, P = 0.03) and decrease in sharing injection equipment (46.3%-19.5%, P = .02). The harm reduction organization experienced an increase of approximately 100-550 program participants and an increase in service delivery area coverage from 1258 to 5509 square miles after intervention implementation (adoption). Cost per participant served by the harm reduction organization was $1486 per year, with annual budget impact to the program of $817 295. In regards to treatment capacity building, a total of 80 providers in the study area completed training in opioid use and/or hepatitis C management. CONCLUSION/CONCLUSIONS:The pragmatic evaluation of harm reduction service expansion supported by a suite of implementation strategies serves to inform the practical considerations and decision-making by community-based organizations seeking to increase services in rural areas heavily affected by substance use, overdose, and related infectious diseases.
PMID: 42400411
ISSN: 1550-5022
CID: 6063922

"It's so much easier for them to just come to us": a qualitative study examining the implementation of mobile methadone treatment serving a residential SUD treatment program

Frank, David; Harris, Samantha J; Song, Minna; Miller, Megan; Ruelas-Vargas, Kristianny; O'Rourke, Allison; Jordan, Ashly E; Saloner, Brendan; Krawczyk, Noa
BACKGROUND:Methadone is a highly effective treatment for opioid use disorder (OUD). Yet its impact is constrained by low rates of treatment initiation and retention, driven in part by geographic inequalities in the availability of methadone-providing opioid treatment programs (OTPs) and restrictions on the types of clinical settings where methadone can be dispensed. In response, in July 2021, the Drug Enforcement Administration released a new rule allowing OTPs to dispense medications for OUD-including methadone-through mobile medication units (MMU) without the need for additional treatment waivers. METHODS:We conducted interviews with 11 participants living in a residential substance use treatment facility in NYC and receiving methadone treatment (MT) from an MMU. Interview data were coded using Dedoose software based on a combination of inductive and deductive coding strategies, and guided by a thematic approach to explore patient's treatment experiences and perceptions. RESULTS:Participants described MMU as substantially reducing the logistical burden of treatment while also allowing patients to avoid problems associated with brick-and-mortar OTPs. Some raised minor complaints (i.e., additional waiting time on medication delivery days), yet participants framed these concerns within the context of their overall preference for MMU. Participants also expressed uncertainty about how methadone treatment would continue after leaving residential care, highlighting potential challenges in transitioning from mobile services to traditional clinic settings. DISCUSSION/CONCLUSIONS:Our findings provide qualitative evidence from patients' perspectives on how mobile methadone delivery can potentially reshape the logistical demands, treatment environments, and continuity-of-care challenges associated with methadone treatment in residential settings.
PMID: 42387639
ISSN: 1940-0640
CID: 6063292

How do services offered within opioid treatment programs vary based on state methadone policies?

Lindenfeld, Zoe; Krawczyk, Noa; Taylor, Erin A; Agniel, Denis; Cantor, Jonathan H
INTRODUCTION/BACKGROUND:State regulations governing opioid treatment programs (OTPs) vary widely in their restrictiveness, yet how state policies relate to the availability of services offered within OTPs remains understudied. In this study, we compare the availability of medication for opioid use disorder (MOUD) options, psychosocial services, and housing supports across OTPs operating in states with different levels of OTP policy restrictions. METHODS:We conducted a cross-sectional study of 1501 opioid treatment programs (OTPs) in the United States. Exposures included 11 state-level OTP policies that impose legal or administrative barriers to opening or operating OTPs or to patients' receipt of care (e.g., pharmacy licensure requirements, zoning restrictions, government identification requirements, and administrative discharge for positive drug screenings). Data on OTP service offerings-including buprenorphine, naltrexone, all three medications for opioid use disorder, mental health services, contingency management, trauma-informed counseling, and housing services-and organizational characteristics were obtained from the 2023 Mental Health and Addiction Treatment Tracking Repository, a national longitudinal database of licensed substance use disorder treatment facilities. These data were linked to a previously developed state policy typology using latent class analysis, which categorized states as having low or high OTP restrictiveness. Regression models adjusted for state- and organizational-level characteristics and accounted for clustering within states. RESULTS:In descriptive analyses, OTPs in highly restrictive states were significantly less likely (p < 0.05) to offer all three MOUDs and behavioral health services, including mental health services, trauma-informed counseling, and contingency management, compared with OTPs in low-restrictiveness states. In adjusted Poisson regression models, facilities in highly restrictive states were significantly less likely to offer naltrexone (ARR: 0.73; 95% CI: 0.54-0.97) and all three MOUDs (ARR: 0.70; 95% CI: 0.53-0.92). CONCLUSIONS:Given that OTPs are the only facilities in which methadone can be legally dispensed, these facilities are a critical point of access for individuals in need of evidence-based OUD treatment. However, our findings suggest that states that place additional restrictions on OTPs also offer less services within their OTPs.
PMID: 42385933
ISSN: 2949-8759
CID: 6063192

Study Design, Methods, and Modeling in Networks to Inform HIV Interventions and Policy in Marginalized Populations

Buchanan, Ashley; Pearsall, Claire; Kogut, Stephen; Bratberg, Jeffrey; Hogan, Joseph; Friedman, Samuel R; Katenka, Natallia
The Networks and Causal Inference for Public Health Research (NCIPHER) Lab at the University of Rhode Island (URI) was established in 2018, with an initial pilot project supported by Advance Rhode Island Clinical Translational Research (RI-CTR), to develop methodological and computational approaches for evaluating interventions in real-world settings where individuals are connected in ways that impact their health. Leveraging bioinformatics and high-performance computing resources through Advance RI-CTR, we integrate empirical and simulation methods to estimate causal intervention effects (i.e., change in an outcome caused by a specific intervention) beyond treated individuals, including spillover through social and healthcare networks and clusters. Our work demonstrates that accounting for spillover improves understanding of the effectiveness of HIV and opioid use disorder (OUD) interventions. In the Transmission Reduction Intervention Project Athens, Greece, participants not exposed themselves to community alerts about HIV risk, with 50% of their immediate contacts exposed, reported three fewer unsafe injection behaviors (per 100 participants), compared to those who had 20% of their contacts exposed (95% CI: -7, 0). We also found 26 fewer reports (per 100 persons) at six months under individual treatment with medication for opioid use disorder with 60% of other individuals in the network treated, compared to no treatment with 20% of others treated (95% CI: -38, -13). Understanding effects in networks can improve translation from intervention delivery to population-level impact, supporting evidence-based policy.
PMID: 42348626
ISSN: 2327-2228
CID: 6056152

"How are we going to be able to pull that off?": staff perspectives on the early implementation of mobile medication units in New York State

Miller, Megan; Song, Minna; Bessler, Alexandra; Ruelas-Vargas, Kristianny; Frank, David; Harris, Samantha J; Gibbons, Jason B; Jordan, Ashly E; Krawczyk, Noa; Saloner, Brendan
BACKGROUND:Methadone is the gold standard treatment for opioid use disorder (OUD). In the U.S., methadone is usually only available through licensed opioid treatment programs (OTPs), but a 2021 federal rule provided an opportunity for OTPs to provide methadone on mobile medication units (MMUs). MMUs operate under the license of an OTP and are subject to complex regulatory requirements. New York State provided grant funding to support OTPs to adopt MMUs, aligned with the broader goal to improve methadone access statewide. This study explored barriers and facilitators to MMU implementation across New York State from the perspectives of treatment staff and administrators. METHODS:We conducted semi-structured interviews between June 2024 and June 2025 with 16 staff from four OTPs that adopted MMUs and one residential treatment program served by an MMU. Interviews were audio-recorded, transcribed, and analyzed using a hybrid deductive-inductive thematic analysis approach to identify implementation barriers and facilitators. RESULTS:Staff described a variety of potential models for using MMUs to expand access. In New York City, MMUs were used to serve a residential substance use program. In upstate NY, MMUs were deployed to reduce travel distance in counties with few OTP options. Key facilitators of MMU implementation included leadership persistence in the face of community pushback, creativity and workarounds in the face of logistical hurdles, and support from the state agency. Key barriers included community resistance to MMUs, unclear or inconsistent guidance from the Drug Enforcement Administration, and a variety of operational challenges, such as vehicle maintenance and workforce shortages. Staff generally were positive about the opportunity to use MMUs to address access challenges. CONCLUSIONS:MMUs provide a novel approach to expand methadone access, particularly to populations not currently served by brick-and-mortar OTPs. Early implementers can provide important lessons about how to manage start-up challenges, which can guide later adopters.
PMCID:13308191
PMID: 42343429
ISSN: 1940-0640
CID: 6056012

International cannabis policies and their association with cannabis use, cannabis use disorder, and other psychiatric disorders

Freeman, Tom P; Thorne, Rachel Lees; Wadsworth, Elle; Carney, Tara; Castillo-Carniglia, Alvaro; Cerdá, Magdalena; Kalayasiri, Rasmon; Kilmer, Beau; Lorenzetti, Valentina; Manthey, Jakob; Myran, Daniel T; Rivera-Aguirre, Ariadne; Rychert, Marta; Wilson, Jack; Yimer, Tesfa; Hall, Wayne
Cannabis policies vary from strict prohibition to commercialised legalisation and are rapidly evolving worldwide. Here, we reviewed evidence for associations between international cannabis policy changes from 2000-25 and cannabis use, cannabis use disorder, and other psychiatric disorders. Commercialised legal markets for non-medical use in Canada and the USA were associated with increased prevalence of cannabis use and cannabis use disorder in adults and increases in cannabis potency since legalisation. There was no consistent evidence for associations between policy change and the prevalence or incidence of psychotic disorders. Commercialised legalisation was associated with an increase in hospital admissions for psychosis, and for psychotic disorders comorbid with cannabis use disorder. Poorly regulated legal access to medical cannabis, in the absence of efficacy and safety data, could increase risk of harm. Policies that limit commercialisation, such as strictly regulated legalisation of medical or non-medical supply, were not as strongly associated with cannabis use or psychiatric disorders, but long-term evaluation is needed. There was little evidence that decriminalisation of non-medical cannabis in Europe, Africa, Oceania, and Asia was associated with cannabis use or psychiatric disorders.
PMID: 42309107
ISSN: 2215-0374
CID: 6049962

Mobile but still tied down: Challenges to scaling mobile methadone through a regulatory thicket

Krawczyk, Noa; Miller, Megan; Frank, David; Harris, Samantha J; O'Rourke, Allison; Song, Minna; Ruelas-Vargas, Kristianny; Gibbons, Jason B; Jordan, Ashly; Saloner, Brendan
Methadone is a highly effective treatment for opioid use disorder. However, its public health impact in the U.S. has long been constrained by strict regulations requiring dispensing through specialty opioid treatment programs (OTPs). In 2021, the U.S. Drug Enforcement Administration authorized mobile medication units (MMUs) to dispense methadone in community settings, raising hopes that mobile delivery could expand access for underserved populations. This commentary examines New York State's early experience implementing MMUs as a case study of both the opportunities and persistent challenges associated with this care delivery model in the U.S. We discuss how burdensome methadone requirements, high start-up and operating costs, complex staffing and logistical burdens, community opposition, and a continued emphasis on diversion control over patient access have limited the ability to effectively scale MMUs as a low-threshold treatment option. Although MMUs have and will continue to improve convenience and access for some patients, their potential to substantially improve geographic access, provide lower-threshold care, and deliver comprehensive OUD services is inhibited by the broader U.S. "methadone exceptionalism" framework, which silos methadone as a separate and more restrictive treatment modality requiring excessive vigilance and oversight . We argue that without greater regulatory clarity, flexibility, and alignment with patient-centered care goals, MMUs may likely remain a welcomed but modest, rather than transformative, innovation in addressing methadone gaps in the United States.
PMID: 42275938
ISSN: 1873-4758
CID: 6048702

Emergence of synthetic drugs in South America: insights from Brazil, Chile, and Colombia

Bórquez, Ignacio; Pantaleão, Bruno; Brogim, Gabriela; da Cunha, Ana Paula; Krawczyk, Noa; Bastos, Francisco I
BACKGROUND:The illicit drug landscape in South America is going through a major shift. The appearance of Tusi (or "pink cocaine"), a mixture often containing ketamine and MDMA, along with the growing presence of synthetic opioids like fentanyl and nitazenes, signals a new chapter in the region's drug use, which has been traditionally dominated by alcohol, cannabis, and cocaine. MAIN BODY/METHODS:Drawing on data on seizures, forensic analyses, warning systems, and surveys from Brazil, Chile, and Colombia, this perspective highlights three movements of the drug supply: non-prescribed and synthetic opioids, ketamine, and Tusi. We also elaborate on their unique public health challenges. Brazil and Chile have seen an increase in non-prescribed opioid use, some of them diverted from healthcare, accompanied by seizures of illicit fentanyl and the discovery of nitazene production in Brazil in May 2025. Colombia, while historically experiencing low opioid use, has documented fentanyl analogs in ketamine and MDMA/Ecstasy samples, mixed with various other contaminants, thus increasing risks among people who use them. Concurrently, ketamine and Tusi use are expanding rapidly across all three countries, particularly among nightclub attendees and youth with criminal-legal involvement. Tusi's unpredictable composition poses heightened overdose risks, especially in settings lacking drug-checking and overdose-prevention education and programs. Furthermore, South America has minimal opioid agonist therapy coverage, limited naloxone access, and underdeveloped harm reduction systems. CONCLUSION/CONCLUSIONS:The emergence of synthetic opioids, ketamine, and Tusi signals a new synthetic drug phase in South America's supply. The convergence of traditional drugs with potent new substances poses important health-related harms. Strengthening regional surveillance, toxicological monitoring, and harm reduction services are urgently needed. Coordinated international research and public health responses will be essential to prevent a drug crisis.
PMID: 42243908
ISSN: 1477-7517
CID: 6044572

Changes in community-level pedestrian stops following overdose prevention center implementation in New York City: An augmented synthetic control approach

Bórquez, Ignacio; Allen, Bennett; Basaraba, Cale; Renson, Audrey; Moore, Brandi; Marshall, Brandon D L; Cerdá, Magdalena
BACKGROUND:Overdose prevention centers (OPCs) may reduce public drug use and, with it, policing of people who use drugs in the communities surrounding these sites. We applied an augmented synthetic control method to assess changes in pedestrian stops before and after the November 2021 opening of two OPCs (Washington Heights and East Harlem) in New York City (NYC). METHODS:We retrieved pedestrian stop information from the New York Police Department's (NYPD) Stop, Question, and Frisk, program from January 2017 to December 2024, and created bimonthly averages using five- and ten-minute walking buffers surrounding the OPCs and 57 donor sites (syringe service and opioid treatment programs) as outcomes. Covariates were derived from American Community Survey, NYPD Calls for Services, and SafeGraph pedestrian mobility estimates. RESULTS:The opening of the Washington Heights OPC was associated with a reduction of 2.8 bimonthly average pedestrian stops in the post-intervention period when using five-minute walking buffers, although results were compatible with increases and reductions (95%CI=-9.4, 4.0). For ten-minute walking buffers, results were compatible with a wide range of reductions (ATT=-9.2 [95%CI=-18.3, -1.3]). East Harlem OPC showed larger point estimates when examining both distances (ATT=-8.4 [95%CI=-12.2, -4.5] and ATT=-13.7 [95%CI=-22.1, -4.2] with five- and ten-minute walking buffers, respectively). For both sites, permutation tests suggested that these reductions fell within the range of possible donor-unit placebo effects. CONCLUSIONS:Our study shows limited evidence of an effect of NYC's first two OPCs on pedestrian stops in their immediate vicinity, with a potential decrease concentrated in the first two years at the East Harlem location.
PMID: 42138361
ISSN: 1531-5487
CID: 6037112

Methadone Diversion and Overdose: What Does the Evidence Say? A Narrative Review

Miller, Megan; Krawczyk, Noa
OBJECTIVES/OBJECTIVE:Policy reforms are being considered to increase methadone treatment (MT) access for opioid use disorder in the United States. Proponents of more structured MT reference risks of diversion, including non-prescribed use or redistribution of methadone, and overdose as arguments for limiting access to specialty settings. However, the scientific evidence behind these claims has not been thoroughly reviewed. METHODS:We conducted a narrative review of studies on methadone diversion, diverted methadone-involved overdoses, and how these compare in countries with specialty-care-only policies (methadone dispensed only through regulated treatment programs) versus general physician-prescribing policies (physicians prescribe methadone in office-based settings). A narrative approach was chosen, given substantial heterogeneity in study designs, diversion definitions, outcome measures, and data sources. We synthesize and discuss findings from international papers published before October 2025. RESULTS:We identified 29 articles studying methadone diversion or diverted methadone-involved overdoses in 7 countries. Lifetime methadone diversion occurrence varied between 6% and 68%, and using diverted methadone occurrence varied between 22% and 88%. Diverting methadone was most often done to help sick friends/partners. Common reasons for using diverted methadone were preventing withdrawal and avoiding opioid use. Three studies found no association between self-reported diverted methadone use and increased individual-level risk of overdose. CONCLUSIONS:The link between specialty-care-only policies and lower diversion and overdose risk is not supported by the reviewed literature. Policymakers should weigh diversion risks against benefits of lives saved through expanded MT access. Further research is needed to better understand the circumstances related to diverted methadone and inform policy-making that appropriately mitigates risks.
PMID: 42008827
ISSN: 1935-3227
CID: 6032342