Quantitative Xylazine Measurement in ED

NCT ID: NCT06949605

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-02-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Opioid Overdose Substance Use Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Suspected Opioid Overdose

Individuals presenting to the ED with a suspected Opioid Overdose with Xylazine exposure.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Love

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Love, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine

Locations

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NYC Health + Hospitals/Elmhurst

Elmhurst, New York, United States

Site Status RECRUITING

Icahn School of Medicine

New York, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Jonathan Berger, MPH

Role: CONTACT

212-824-8046

Other Identifiers

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5R25DA058490-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-24-01068

Identifier Type: -

Identifier Source: org_study_id

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