Acute Cannabis-induced CNS Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Anebulo Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria:The patient is younger than 18 years old. 2. 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). 3. Blood samples are taken as part of routine clinical procedures, or the patient has an IV line through which blood can be taken. 4. The LAR is willing and able to provide consent. 5. The patient is willing and able to provide assent, if applicable and feasible, based on age and clinical condition.
Exclusion criteria
A potential patient who meets any of the following criteria will be excluded from participation in this study: 1. 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. 2. 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. 3. Patient presenting with cannabis use disorder (CUD), cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS) 4. Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of delta-9 tetrahydrocannabinol (THC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Baseline | Describe the demographics of patients with acute cannabis-induced CNS depression |
| Cannabis Exposure | Baseline | Dose of cannabis ingested |
| Cannabis-Related Symptoms | Baseline, 30 minutes, 1 hour, 6 hours | Clinical symptoms resulting from cannabis exposure |
| Richmond Agitation and Sedation (RASS) Score | Baseline, 30 minutes, 1 hour, 6 hours | The RASS evaluates a patient's level of agitation or sedation on a 10-point scale ranging from +4 (combative) to -5 (unarousable) with zero representing a calm, alert state |
| Glasgow Coma Scale (GCS) Score | Baseline, 30 minutes, 1 hour, 6 hours | The GCS assesses a patient's level of consciousness based on eye opening, verbal response, and motor response. The total score ranges from 3 (deep unconsciousness to 15 (fully alert) |
| Caregiver Global Impression of Change (CaGI-C) | Baseline, 6 hours | The CaGI-C is completed by the caregiver or legally authorized representative and captures their overall impression of how the child's condition has changed since arrival at the emergency department. It will be measured using a 7-point Likert scale ranging from 1 (very much improved) to 7 (very much worse) |
| Hospital or Intensive Care Unit Admission | From Enrollment Through Time of Discharge, up to 24 hours | This assesses whether the subject was admitted to the hospital or intensive care unit. It is a binary measure and can be yes or no. |
| Time to Discharge | From Enrollment Through Time of Discharge, up to 24 hours | This assesses the time from arrival at the emergency department until the subject is released. It is measured in minutes. |
| Need for Positive Pressure Ventilation | From Enrollment Through Time of Discharge, up to 24 hours | This is a binary assessment (yes or no) and captures whether the subject required ventilation assistance due to the cannabinoid exposure. |
| Occurrence of Seizures Requiring Intervention | From Enrollment Through Time of Discharge, up to 24 hours | This is a binary assessment (yes or no) and captures whether the subject experienced seizures which required intervention during the visit to the emergency department. |
Countries
United States
Contacts
CONTACTLinda Klumpers, PhD
CONTACTKen Cundy, PhD
STUDY_DIRECTORKen Cundy, PhD
Anebulo Pharmaceuticals Inc.
Outcome results
None listed