Naloxone

Opioid overdose deaths have reached record highs in the United States, especially among patients discharged from emergency departments (ED). This research aims to evaluate a bundled intervention combining telehealth, peer support, buprenorphine treatment, and linkage to addiction programs to increase treatment uptake, reduce repeat opioid overdoses, and lower mortality in patients with opioid use disorder (OUD) after ED discharge. The study is supported by the HEAL Initiative and focuses on patients with recent opioid overdoses who face barriers to treatment after leaving the ED. The study includes two phases. In phase 1, 30 patients discharged from the ED will receive daily peer support via telehealth during the first week, then less frequently over 12 weeks, alongside buprenorphine prescribed by physicians. In phase 2, about 160 participants will be randomized to either the same bundled intervention or usual care, which includes ED-initiated buprenorphine and referral lists but no ongoing peer support. The intervention lasts 3 months post-ED discharge, and participants in all groups will complete follow-up surveys at 1 and 3 months. Participants will be involved in baseline assessments, receive the intervention or usual care after ED discharge, and complete self-report questionnaires through electronic surveys at 1 and 3 months. Peer supporters will remind participants to complete surveys. The study will measure treatment retention, adherence to buprenorphine, and successful linkage to addiction treatment programs at 1 and 3 months after ED discharge. These outcomes will help assess the feasibility and impact of this bundled approach to reduce opioid overdose risks and improve care continuity.

Opioid overdose causes significant global health problems, and while prevention and treatment programs exist, more efforts are needed to reduce deaths and complications. This research evaluates a novel smartphone-based volunteer first responder system integrated with national emergency call services to assist suspected opioid overdoses. The system aims to alert trained volunteers equipped with naloxone, an opioid antidote, to provide early treatment before emergency medical services arrive, potentially saving lives by reducing the time to naloxone administration. Volunteer responders, called naloxone-responders, will complete training in opioid overdose recognition, naloxone use, and first aid based on European and Swedish guidelines. They will also learn low-arousal communication techniques for interacting with overdose victims. Each responder receives a kit with two doses of nasal naloxone and will be registered on a dedicated responder smartphone app. The study includes a two-year pilot phase with one-year follow-up per participant, along with multiple sub-studies examining feasibility, safety, acceptability, mortality, and experiences of responders and overdose survivors. Participants will be monitored through questionnaires, app data, and medical records from dispatchers, paramedics, and hospitals. The primary outcomes include the number of successful naloxone responder alerts, responder acceptability, clinical outcomes of overdose victims, and safety experiences during alerts. Mortality rates before and after the trial will also be analyzed. The study runs from September 2025 to August 2027, assessing both short- and long-term effects of integrating volunteer responders with emergency medical dispatch.

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Adolescent overdose deaths are a leading cause of death among youth aged 10 to 19 in the United States, with numbers continuing to rise. Researchers are evaluating a brief overdose prevention education intervention designed for youth in primary care settings. This pilot study aims to assess how feasible and acceptable this intervention is for both healthcare providers and young patients, addressing a gap as there are currently no recommended overdose prevention programs specifically for youth in healthcare. In this two-arm cluster randomized controlled trial, pediatric and family medicine providers are randomly assigned to either deliver the brief overdose prevention education or provide usual care. Providers in the intervention group receive a 45-minute training, conducted in person or via Zoom, which covers overdose prevention education, intervention delivery, practice, and fidelity checklist completion. The intervention includes informing youth about overdose risk factors, safety strategies, recognizing and responding to overdoses, and naloxone use, with naloxone kits offered to take home. Youth participants aged 13 to 26 scheduled for a comprehensive physical exam with participating providers complete assessments at baseline, 2 weeks, and 6 months. Researchers will measure the feasibility and acceptability of the intervention by providers and youth, as well as youth knowledge and skills related to overdose risk, recognition, and response. The study excludes youth unable to consent or with cognitive limitations or acute medical/psychiatric distress. Participation is tracked over six months to evaluate the intervention's impact and acceptability.

Researchers are evaluating the effects of an emergency department community health worker-peer recovery specialist program called the Substance Misuse Assistance Response Team (SMART) on people with substance use disorders. This observational, prospective case-control study aims to understand participant experiences with SMART, evaluate its effectiveness on recovery outcomes and linkage to treatment, and assess program implementation over time. The study focuses on improving recovery service connections for patients after substance use-related emergency visits, a critical time when the risk of death is elevated. The study compares two groups: patients who receive SMART services and those who do not. SMART provides personalized support, short-term case management, and navigation to social services, harm reduction, recovery, and addiction treatment both inside and outside the emergency department. Services include assistance with buprenorphine initiation, behavioral counseling, and help accessing housing, transportation, and other social resources. Patients not receiving SMART services receive usual care with referral at the emergency department team's discretion. Participants will complete surveys at enrollment, and again at 3 and 6 months after their initial emergency visit. Researchers will link survey data with state administrative databases to measure outcomes such as addiction treatment engagement, recovery capital, social services use, acute care visits, repeat hospitalizations and overdoses, mortality, employment changes, and criminal justice encounters. The study will provide important information about how SMART impacts patient outcomes and program delivery, with follow-up through October 2026.

This research aims to improve the use of naloxone, a medication that can reverse opioid overdoses, among opioid users discharged from the emergency department. It focuses on increasing the rate at which patients fill their naloxone rescue kit prescriptions, especially those at high risk who have visited the emergency department due to opioid overdose. The trial compares two education approaches to see which better encourages patients to fill their prescriptions and retain important knowledge about naloxone use. Participants will be randomly assigned to one of two groups. One group receives standard education consisting of written instructions delivered through their MyChart account covering key facts about opioid overdose and naloxone use. The other group receives enhanced overdose education (EOE), which includes a concise one-page pamphlet and a four-minute video shown with the participant and a support person before discharge. The EOE emphasizes understanding naloxone's importance and instructs both the patient and their support network on how to use the rescue kit. During the study, researchers will monitor if participants fill their naloxone prescription within one month after discharge. They will also assess how well participants and their support individuals remember the education content about naloxone. Data collection includes surveys and qualitative exploration of reasons why the prescription was or was not filled. The goal is to gather preliminary information that may help reduce opioid overdose deaths by improving naloxone availability.

Researchers are evaluating a clinician-targeted behavioral nudge intervention embedded in the Electronic Health Record (EHR) to help identify patients at higher risk for opioid overdose using a machine-learning based risk prediction model. This trial aims to improve opioid prescribing safety and reduce overdose risk by comparing usual care to enhanced care with flags and behavioral nudges for clinicians in primary care settings. The study includes three groups: one receiving usual care without changes, one with an elevated-risk flag displayed in the EHR during patient encounters, and one with the flag combined with best practice alerts or behavioral nudges triggered under specific conditions. These nudges encourage safer prescribing, such as prescribing naloxone or providing justification for high opioid doses or overlapping prescriptions. Participants are patients who have received an opioid prescription and visited a primary care practice in the last year. Researchers will assess prescribing practices at 4 and 6 months after enrollment, including measures like naloxone prescriptions, opioid dosage, and overlapping medications. The study will monitor emergency department or inpatient visits for overdose and overall visits to evaluate the intervention's impact on patient safety and prescribing behavior.

This research aims to evaluate the effects of harm reduction initiatives on overdose and other health outcomes among people experiencing homelessness in New York City shelters. The study uses mixed methods, including analysis of administrative homeless services and Medicaid data, as well as in-depth interviews and focus groups. It focuses on the implementation and impact of a Harm Reduction Strategic Plan (HRSP) within the NYC single-adult shelter system. The study involves analyzing data from individuals in the NYC single-adult homeless services system from 2021 to 2026. It also conducts qualitative interviews and focus groups with homeless services providers, administrators, clients who have received HRSP interventions, and stakeholders involved in planning and implementing these interventions. These activities aim to capture diverse perspectives on the HRSP's effects. Participants' involvement includes data analysis without direct contact for some aims, and interviews or focus groups for others. Researchers will assess outcomes such as the incidence of fatal and non-fatal overdoses, substance use disorder treatment initiation, and health services use. The study will monitor these measures using administrative data, while qualitative sessions explore personal experiences. The total study period spans several years, allowing for comprehensive evaluation over time.

Researchers are evaluating if the UnityPhilly overdose prevention app can encourage people to respond and prevent opioid overdoses in Philadelphia. This behavioral clinical trial focuses on how different groups of individuals use the app, along with training and naloxone provision, to react to overdoses and reduce opioid-related harm. The study will enroll participants from various backgrounds, such as active opioid users, people in recovery, caregivers, and concerned community members. Participants will receive the UnityPhilly app and training on its use and how to respond to opioid overdoses using naloxone. All 450 enrolled participants will use the app over a 12-month period, and the study will track their responses and experiences. Additionally, 3,000 community volunteers will be engaged over two years to assess the app's sustainability and community reach. During the study, participants will complete surveys and interviews about their experiences with the app and overdose response. Researchers will collect data on overdose alerts, responses, and reversals, examining these outcomes over time. The study will also evaluate the app's adoption and effectiveness across different user groups and neighborhoods, with a total follow-up duration extending up to two years.

Researchers are evaluating the Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES), a community-based program designed to support youths with opioid use disorder (OUD). The study aims to compare how different approaches affect engagement and retention in treatment, while understanding the rates of opioid overdoses and OUD among youth in Houston. This non-randomized cohort study involves youths aged 13 to 17 who have experienced opioid dependence or overdose. The study provides treatment involving same-day induction into medication for opioid use disorder (MOUD) using an 8mg buprenorphine/2mg naloxone combination, combined with behavioral counseling, peer recovery support, and assertive outreach by a paramedic and peer coach. Participants receive ongoing maintenance treatment, referrals to youth-focused support groups, and long-term MOUD provider referrals. Weekly outreach efforts support youths after opioid overdoses to encourage treatment initiation. Participants will be assessed on engagement and retention in outpatient treatment 30 days after enrollment, along with opioid abstinence. Researchers also monitor quality of life, relapse rates, and frequency of opioid emergencies over an average of three years. Assessments include drug screening and medical evaluations, while peer support is available 24/7. Participation involves signing informed consent and assent, with monitoring of safety and treatment adherence throughout the study period ending in August 2030.