RecruitingNCT06017622
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Pediatric Patients Visiting Emergency Departments for Acute Cannabis-induced CNS Depression
Sponsor
Anebulo Pharmaceuticals
Enrollment
36 participants
Start Date
Jun 1, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria5
- 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).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06017622