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Naloxone clinical trials explore its use primarily in emergency and preventive care related to opioid overdose. These studies assess various administration methods, dosing strategies, and safety profiles to optimize the effectiveness and accessibilit...

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Found 8 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 19Years +All GendersPhase 1Phase 2
1 location
F

Actively Recruiting

Healthy Volunteer

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.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

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.

Age: 75Years +All GendersPhase Not Applicable
1 location
E

Actively Recruiting

Healthy Volunteer

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 teams 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.

Age: 18Years +All Genders
1 location
U

Actively Recruiting

This clinical trial focuses on patients at risk of opioid overdose identified through a machine-learning based risk prediction model. The study aims to evaluate a behavioral nudge intervention delivered via the Electronic Health Record EHR to improve opioid prescribing safety and reduce overdose risk. The trial compares usual care to interventions involving an elevated-risk flag and behavioral nudges targeted at clinicians in primary care settings. Participants are divided into three groups usual care without changes, an elevated-risk flag displayed in the EHR during patient encounters, and an elevated-risk flag combined with best practice alerts or behavioral nudges that prompt clinicians under specific conditions. These nudges encourage safer prescribing behaviors such as naloxone prescription and require clinicians to justify certain opioid-related orders. During the study, participants are monitored through primary care visits where the EHR interventions are applied. Outcomes include composite scores of prescribing practices assessed at 4 and 6 months after enrollment, as well as measures such as naloxone prescriptions, opioid dosage levels, overlapping prescriptions, and emergency visits related to overdose. The researchers will evaluate changes in clinician prescribing behavior and patient safety over the course of the trial.

Age: 18Years +All GendersPhase Not Applicable
1 location
E

Actively Recruiting

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 HRSPs 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.

Age: 18Years +All Genders
1 location
E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the UnityPhilly app, which aims to help citizen responders prevent opioid overdoses in Philadelphia. This behavioral clinical trial focuses on how different groups of people use the app to signal overdoses and respond with naloxone, a medication that can reverse overdoses. The study includes people who use opioids non-medically, those on prescription opioids, individuals in recovery, caregivers, and concerned community members to understand app effectiveness in various settings. All participants will receive training on how to use the UnityPhilly app and respond to overdoses with naloxone. The study enrolls 450 participants over 9 months from three Philadelphia neighborhoods, who will use the app and be followed for 12 months to measure outcomes such as overdose signaling and response rates. Additionally, 3,000 resident volunteers will download and use the app over two years to assess its sustainability and community reach. Participants will be involved in training, using the app, and completing follow-up surveys about their experiences. Data collected includes app usage logs, survey responses, and interviews to evaluate how well the app helps prevent overdoses and how widely it is adopted. The study will measure the rates of overdoses signaled and reversed over two years, with ongoing assessments to understand the apps long-term impact and effectiveness.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

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 buprenorphine2mg 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 247. Participation involves signing informed consent and assent, with monitoring of safety and treatment adherence throughout the study period ending in August 2030.

Age: 13Years - 17YearsAll GendersPhase 4
1 location

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