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

Recruiting now

Conditions studied: Acute Cannabis-induced CNS Depression

In brief

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.

Key facts

Study ID

NCT06017622

Run by

Anebulo Pharmaceuticals

People needed

36

Starts

2023-06-01

Expected to finish

2026-12-30

Last updated by the study team

2026-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Massachusetts Memorial Children's Medical Center — Worcester, Massachusetts, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Sciences University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.