Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression

Официальное название

Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Pediatric Patients Visiting Emergency Departments for Acute Cannabis-induced CNS Depression

Обзор

This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of pediatric patients who visit the emergency department due to acute cannabis-induced CNS depression.

Подробное описание

This is a multi-center, prospective, cross-sectional observational study to determine the concentrations of tetrahydrocannabinol (THC) and its metabolites (and/or other cannabinoids) in the plasma of pediatric patients admitted to emergency departments with acute cannabis-induced CNS depression. .The study will explore the relationships between these concentrations and parameters such as demographics, symptom severity, time to symptom resolution, and clinical outcomes.

Samples will be collected as part of standard clinical procedure without requiring study participants to spend additional time in the hospital.

Первичные конечные точки

• Plasma Concentration of delta-9 tetrahydrocannabinol (THC) [Срок оценки: Day 1]

Вторичные конечные точки (10)

• Demographics [Срок оценки: Baseline]
• Cannabis Exposure [Срок оценки: Baseline]
• Cannabis-Related Symptoms [Срок оценки: Baseline, 30 minutes, 1 hour, 6 hours]
• Richmond Agitation and Sedation (RASS) Score [Срок оценки: Baseline, 30 minutes, 1 hour, 6 hours]
• Glasgow Coma Scale (GCS) Score [Срок оценки: Baseline, 30 minutes, 1 hour, 6 hours]
• Caregiver Global Impression of Change (CaGI-C) [Срок оценки: Baseline, 6 hours]
• Hospital or Intensive Care Unit Admission [Срок оценки: From Enrollment Through Time of Discharge, up to 24 hours]
• Time to Discharge [Срок оценки: From Enrollment Through Time of Discharge, up to 24 hours]
• Need for Positive Pressure Ventilation [Срок оценки: From Enrollment Through Time of Discharge, up to 24 hours]
• Occurrence of Seizures Requiring Intervention [Срок оценки: From Enrollment Through Time of Discharge, up to 24 hours]

Критерии участия

Критерии включения

• Inclusion Criteria:The patient is younger than 18 years old.
• The patient visits the ED with signs and symptoms of suspected acute cannabis-induced CNS depression, as evidenced by the patient suffering from clinically significant CNS depression combined with the following criteria:

a) Exposure to cannabis or cannabis-derived products, or other products containing any CB1 agonist (such as Δ8-THC, HHC) within the last 12 hours, confirmed through one or more of the following: i. Positive toxicology testing, or ii. Other clinical evidence, such as reliable collateral history (e.g., from caregivers, EMS personnel, or witnesses), physical evidence (e.g., product packaging), or a consistent self-report.

AND EITHER

b) Symptoms are associated with cannabis exposure and developed during, or shortly after, cannabis exposure;

OR

c) In the judgment of investigator or designated clinician, the presentation includes symptoms consistent with acute cannabis-induced CNS depression (e.g. respiratory rate depression, increased sedative effects).

• Blood samples are taken as part of routine clinical procedures, or the patient has an IV line through which blood can be taken.
• The LAR is willing and able to provide consent.
• The patient is willing and able to provide assent, if applicable and feasible, based on age and clinical condition.

Критерии исключения

A potential patient who meets any of the following criteria will be excluded from participation in this study:

• Anything that, in the opinion of the PI, would place the patient at increased risk or preclude the patient's compliance with or completion of the study.
• Patient is presenting with signs or symptoms that are better explained by another medical condition or mental disorder, exposure to a drug other than cannabis, and, at the PI's discretion, are not induced by acute cannabis exposure.
• Patient presenting with cannabis use disorder (CUD), cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS)
• Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• University of Massachusetts Memorial Children's Medical Center — Worcester
• Cincinnati Children's Hospital — Cincinnati
• Oregon Health and Sciences University — Portland

Идентификаторы

NCT: NCT06017622 · AN01AC01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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