Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Pediatric Patients Visiting Emergency Departments for Acute Cannabis-induced CNS Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •b) Symptoms are associated with cannabis exposure and developed during, or shortly after, cannabis exposure;
- •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.
排除标准
- •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).
研究组 & 干预措施
All subjects
There is a single group consisting of all subjects who meet the eligibility criteria
结局指标
主要结局
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
时间窗: Day 1
Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabis induced CNS depression.
次要结局
- Demographics(Baseline)
- Cannabis Exposure(Baseline)
- Cannabis-Related Symptoms(Baseline, 30 minutes, 1 hour, 6 hours)
- Richmond Agitation and Sedation (RASS) Score(Baseline, 30 minutes, 1 hour, 6 hours)
- Glasgow Coma Scale (GCS) Score(Baseline, 30 minutes, 1 hour, 6 hours)
- Caregiver Global Impression of Change (CaGI-C)(Baseline, 6 hours)
- Hospital or Intensive Care Unit Admission(From Enrollment Through Time of Discharge, up to 24 hours)
- Time to Discharge(From Enrollment Through Time of Discharge, up to 24 hours)
- Need for Positive Pressure Ventilation(From Enrollment Through Time of Discharge, up to 24 hours)
- Occurrence of Seizures Requiring Intervention(From Enrollment Through Time of Discharge, up to 24 hours)