Quantitative Xylazine Measurement in ED

March 24, 2026 updated by: Jennifer Love, Icahn School of Medicine at Mount Sinai

Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose Patients in the Emergency Department

Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose (OD) Patients in the Emergency Department (ED)

Study Overview

Status

Completed

Conditions

Detailed Description

Xylazine, a veterinary medication and alpha-2 agonist drug with clinical effects including prolonged sedation and skin/soft tissue wounds, has been increasingly detected with fentanyl in the illicit opioid supply. Due to its rapid emergence, limited knowledge exists regarding xylazine's health effects. In this proposed research, Dr. Love will measure xylazine and its metabolites in blood and urine samples using laboratory and point-of-care assays. Working at two New York City emergency departments, Dr. Love will collect waste serum and urine from opioid overdose patients to measure xylazine and its metabolite concentrations. The researcher will also perform qualitative assessment of urine samples with xylazine test strips to characterize urine xylazine detection using a harm reduction tool.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Elmhurst, New York, United States, 11373
        • NYC Health + Hospitals/Elmhurst
      • New York, New York, United States, 10029
        • Icahn School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participating sites will enroll all opioid ODs presenting to Mount Sinai Hospital and Elmhurst Hospital Emergency Departments, regardless of whether or not a consultation by a medical toxicologist was requested (i.e., all consecutive opioid ODs).

Description

Inclusion Criteria:

  • ED patient
  • Opioid OD (both NPS and non-NPS)
  • Availability of waste blood specimens for analysis
  • Availability of waste urine specimens for analysis

Exclusion Criteria:

- Children under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suspected Opioid Overdose
Individuals presenting to the ED with a suspected Opioid Overdose with Xylazine exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xylazine Concentration in Blood
Time Frame: 6 months
Concentration of Xylazine in blood as determined by lab.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xylazine Strip Specificity and Sensitivity
Time Frame: 6 months
Measuring Xylazine test strip specificity and sensitivity using excess urine samples.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Jennifer Love, MD, MS, Icahn School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-24-01068
  • 5R25DA058490-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not a clinical trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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