Clinical Research Directory

CytOSorb TreatMent Of Critically Ill PatientS Registry

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

The ENHANCE Project Toolkit

This study will examine the feasibility, appropriateness, and acceptability of a bundle of smartphone-based tools for lowering overdose risk. 40 participants will be enrolled and can expect to be on study for up to 9 months.

Clinician Practice Companion to Address Youth Substance Use

Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States. Many young people who use substances also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care exist, including overdose prevention and safety strategies (such as naloxone) and medications for addiction treatment. These approaches remain adult-oriented, however, unevenly implemented in youth-serving settings, and insufficiently centered on the needs and goals of youth and their families. This study develops and pilot tests a written "practice companion" that helps clinicians and other trusted adults provide developmentally appropriate substance use care to youth ages 14 to 24 in hospital and community settings. The practice companion offers practical, easy-to-use guidance organized by substance and by pattern of use. It addresses cannabis and other substances that youth commonly use and that clinicians frequently seek support with, alongside a strong focus on overdose prevention through its core elements: naloxone, other safety strategies, overdose prevention and safety education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how poverty, housing instability, and other social circumstances shape substance use and access to care. The research team will first interview youth who use substances, their families and caregivers, and clinicians to learn how each element of care should be adapted for young people. The team will then produce the practice companion and pilot test it with 60 youth across three sites, in British Columbia, Québec, and Massachusetts. After receiving care guided by the practice companion, youth will complete an interview about whether the care was relevant, useful, appropriate, and acceptable. Families and clinicians will also be interviewed to assess how feasible, sustainable, and faithful to its design the practice companion is in practice. Throughout the study, the team will work closely with youth and families who have lived experience through a community-based participatory research approach that includes Community Advisory Boards. Findings will guide a larger future study of the practice companion's effectiveness.

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

This study will test the effectiveness, implementation outcomes, and cost effectiveness of a locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of overdoses, hepatitis C, and injection-related infections.

Behavioral Safety and Fentanyl Education: BSAFE

BSAFE is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among people who use stimulants who may have unintentional fentanyl use (UFU). It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of BSAFE vs attention-control.

A Setting Focus Overdose Prevention Intervention

A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).

Justice Community Overdose Innovation Network II TCU Hub

The current study proposes to use a Hybrid Type 3 implementation research strategy to: 1) Significantly enhance our understanding of public health outcomes \[e.g., overdose incidents and substance-use (SU)-related Emergency Medical Service (EMS) contacts\] and public safety outcomes (e.g., drug-related arrests) associated with Deflection and Pre-Arrest Diversion initiatives (DPAD, hereafter referred to as Deflection); and 2) Create a lasting contribution to the fields of research focused on SU and the criminal legal system (CLS) by advancing knowledge of effective implementation strategies involving the critical role of community engagement in Deflection. The highly experienced team of Multiple PIs, senior-level collaborators from both Deflection and Community Behavioral Health (CBH), state-level evaluation partners, a national stakeholder advisory group, and CLS and behavioral health partners within each community have teamed up to carry out the proposed project. The study approach uses a hybrid implementation-effectiveness design to examine strategies to improve opioid and stimulant relevant outcomes, and specifically proposes to test the implementation-effectiveness of 2 strategy bundles to promote Deflection models through a CORE community engagement bundle (designed to facilitate community stakeholder engagement) and ENHANCED community engagement bundle (CORE plus a component to systematically involve community advocates) on improving implementation as well as public safety and health outcomes. The proposed randomized control trial includes a total of 20 geographically distinct clinical research performance sites (i.e., 20 communities spanning 5 states; New Mexico, Illinois, Wisconsin, Colorado, and Pennsylvania), with 3-5 communities per state and the inclusion of key CLS and CBH stakeholders within each site. The large scope of the project will maximize potential generalizability of study results and sustainability of implementation strategies.

Preventing Overdose Using Information and Data From the Environment

The objectives of this project are to leverage surveillance data to predict future overdose outbreaks, and to evaluate the impact of a randomized, statewide, community-level intervention trial to target overdose prevention programs to neighborhoods at highest risk of future overdose deaths. This study develops and tests an opioid overdose forecasting tool, which will allow other states to identify and deploy interventions to communities at highest risk of opioid-related death. The findings from this study have the potential to significantly improve the allocation of resources to curb the opioid overdose epidemic in the United States.

Social Network Overdose Prevention and Education Intervention

The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs).

Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning

This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.