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NCT Number: NCT06017622

Observational Study of THC Concentrations in 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Massachusetts Memorial Children's Medical Center, Worcester, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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).

Treatment and study plan

Primary outcomes

  1. Plasma Concentration of delta-9 tetrahydrocannabinol (THC)

    Time frame: Day 1

    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.

Secondary outcomes

  1. Demographics

    Time frame: Baseline

    Describe the demographics of patients with acute cannabis-induced CNS depression

  2. Cannabis Exposure

    Time frame: Baseline

    Dose of cannabis ingested

  3. Cannabis-Related Symptoms

    Time frame: Baseline, 30 minutes, 1 hour, 6 hours

    Clinical symptoms resulting from cannabis exposure

  4. Richmond Agitation and Sedation (RASS) Score

    Time frame: Baseline, 30 minutes, 1 hour, 6 hours

    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

  5. Glasgow Coma Scale (GCS) Score

    Time frame: Baseline, 30 minutes, 1 hour, 6 hours

    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)

  6. Caregiver Global Impression of Change (CaGI-C)

    Time frame: Baseline, 6 hours

    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)

  7. Hospital or Intensive Care Unit Admission

    Time frame: From Enrollment Through Time of Discharge, up to 24 hours

    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.

  8. Time to Discharge

    Time frame: From Enrollment Through Time of Discharge, up to 24 hours

    This assesses the time from arrival at the emergency department until the subject is released. It is measured in minutes.

  9. Need for Positive Pressure Ventilation

    Time frame: From Enrollment Through Time of Discharge, up to 24 hours

    This is a binary assessment (yes or no) and captures whether the subject required ventilation assistance due to the cannabinoid exposure.

  10. Occurrence of Seizures Requiring Intervention

    Time frame: From Enrollment Through Time of Discharge, up to 24 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ken Cundy, PhD

CONTACT

[email protected]

512-598-0931

Linda Klumpers, PhD

CONTACT

[email protected]

512-598-0931

Sponsors and collaborators

Lead sponsor

Anebulo Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.