NCT06949605

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

April 22, 2025

Last Update Submit

March 24, 2026

Conditions

Opioid OverdoseSubstance Use Disorders

Keywords

OpioidXylazineSubstance Use

Outcome Measures

Primary Outcomes (1)

  • Xylazine Concentration in Blood

    Concentration of Xylazine in blood as determined by lab.

    6 months

Secondary Outcomes (1)

  • Xylazine Strip Specificity and Sensitivity

    6 months

Study Arms (1)

Suspected Opioid Overdose

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • \- Children under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYC Health + Hospitals/Elmhurst

Elmhurst, New York, 11373, United States

Location

Icahn School of Medicine

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine and Waste Blood/Serum

MeSH Terms

Conditions

Opiate OverdoseSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Drug OverdosePrescription Drug MisuseDrug MisuseChemically-Induced DisordersOpioid-Related DisordersNarcotic-Related DisordersMental Disorders

Study Officials

  • Jennifer Love, MD, MS

    Icahn School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

April 1, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Not a clinical trial

Locations

US(2)