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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Linda Klumpers, PhD; Phone Number: 512-598-0931; Email: linda@anebulo.com
• Study Contact Backup: Name: Ken Cundy, PhD; Phone Number: 512-598-0931; Email: ken@anebulo.com

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • University of Massachusetts Memorial Children's Medical Center
      • Contact: Zachary W. Binder, MD; Phone Number: 508-334-6090; Email: Zachary.binder@umassmemorial.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of pediatric patients under 18 years of age who present to an emergency department with acute cannabis-induced CNS depression .

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All subjects; There is a single group consisting of all subjects who meet the eligibility criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Describe the demographics of patients with acute cannabis-induced CNS depression	Baseline
Cannabis Exposure	Dose of cannabis ingested	Baseline
Cannabis-Related Symptoms	Clinical symptoms resulting from cannabis exposure	Baseline, 30 minutes, 1 hour, 6 hours
Richmond Agitation and Sedation (RASS) Score	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	Baseline, 30 minutes, 1 hour, 6 hours
Glasgow Coma Scale (GCS) Score	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)	Baseline, 30 minutes, 1 hour, 6 hours
Caregiver Global Impression of Change (CaGI-C)	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)	Baseline, 6 hours
Hospital or Intensive Care Unit Admission	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.	From Enrollment Through Time of Discharge, up to 24 hours
Time to Discharge	This assesses the time from arrival at the emergency department until the subject is released. It is measured in minutes.	From Enrollment Through Time of Discharge, up to 24 hours
Need for Positive Pressure Ventilation	This is a binary assessment (yes or no) and captures whether the subject required ventilation assistance due to the cannabinoid exposure.	From Enrollment Through Time of Discharge, up to 24 hours
Occurrence of Seizures Requiring Intervention	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.	From Enrollment Through Time of Discharge, up to 24 hours

Collaborators and Investigators

• Sponsor: Anebulo Pharmaceuticals
• Investigators: Study Director: Ken Cundy, PhD, Anebulo Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AN01AC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No