Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT06949605
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2025-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative Xylazine Measurement in ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083682', 'term': 'Opiate Overdose'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine and Waste Blood/Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Xylazine Concentration in Blood', 'timeFrame': '6 months', 'description': 'Concentration of Xylazine in blood as determined by lab.'}], 'secondaryOutcomes': [{'measure': 'Xylazine Strip Specificity and Sensitivity', 'timeFrame': '6 months', 'description': 'Measuring Xylazine test strip specificity and sensitivity using excess urine samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid', 'Xylazine', 'Substance Use'], 'conditions': ['Opioid Overdose', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose (OD) Patients in the Emergency Department (ED)', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ED patient\n* Opioid OD (both NPS and non-NPS)\n* Availability of waste blood specimens for analysis\n* Availability of waste urine specimens for analysis\n\nExclusion Criteria:\n\n\\- Children under 18'}, 'identificationModule': {'nctId': 'NCT06949605', 'briefTitle': 'Quantitative Xylazine Measurement in ED', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Quantitative Xylazine Measurement Among Non-Fatal Opioid Overdose Patients in the Emergency Department', 'orgStudyIdInfo': {'id': 'STUDY-24-01068'}, 'secondaryIdInfos': [{'id': '5R25DA058490-02', 'link': 'https://reporter.nih.gov/quickSearch/5R25DA058490-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected Opioid Overdose', 'description': 'Individuals presenting to the ED with a suspected Opioid Overdose with Xylazine exposure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11373', 'city': 'Elmhurst', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYC Health + Hospitals/Elmhurst', 'geoPoint': {'lat': 40.73649, 'lon': -73.87791}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jonathan Berger, MPH', 'role': 'CONTACT', 'email': 'jonathan.berger@mountsinai.org', 'phone': '212-824-8046'}], 'overallOfficials': [{'name': 'Jennifer Love, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not a clinical trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Love', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}