Observing THC Levels in Patients with Acute Cannabinoid Intoxication

Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Pediatric Patients Visiting Emergency Departments for Acute Cannabis-induced CNS Depression

This study is trying to see how much THC is in the blood of people who go to the emergency room after using too much cannabis and how it relates to their symptoms and recovery.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Sex: All
• Sponsor: Anebulo Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Worcester, Massachusetts)
• Trial ID: NCT06017622 on ClinicalTrials.gov

What this trial studies

This observational study aims to measure the plasma concentrations of tetrahydrocannabinol (THC) and its metabolites in patients who visit emergency departments due to acute cannabinoid intoxication. It is a multi-center, prospective, cross-sectional study that will analyze the relationship between THC levels and various factors such as demographics, symptom severity, and clinical outcomes. Samples will be collected as part of standard clinical procedures, ensuring minimal disruption to patient care.

Who should consider this trial

Good fit: Ideal candidates are individuals who have recently used cannabis and are experiencing acute intoxication symptoms.

Not a fit: Patients who do not exhibit acute cannabinoid intoxication or have not used cannabis recently will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of THC's effects and improve clinical management of cannabinoid intoxication.

How similar studies have performed: While there have been studies on cannabinoid effects, this specific observational approach to THC concentration in acute intoxication is relatively novel.

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 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).

Where this trial is running

Worcester, Massachusetts

• University of Massachusetts Memorial Children's Medical Center — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Linda Klumpers, PhD

Conditions Acute Cannabis-induced CNS Depression