NCT06017622 Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
| NCT ID | NCT06017622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anebulo Pharmaceuticals |
| Condition | Acute Cannabis-induced CNS Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-12-30 |
Trial Parameters
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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.
Eligibility Criteria
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 depressi
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