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

NCT06017622 | Recruiting

• 1 other identifier: AN01AC01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cannabis-induced CNS Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Demographics

  Baseline

• Cannabis Exposure

  Baseline

• Cannabis-Related Symptoms

  Baseline, 30 minutes, 1 hour, 6 hours

• Richmond Agitation and Sedation (RASS) Score

  Baseline, 30 minutes, 1 hour, 6 hours

• Glasgow Coma Scale (GCS) Score

  Baseline, 30 minutes, 1 hour, 6 hours

Study Arms (1)

All subjects

There is a single group consisting of all subjects who meet the eligibility criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Anebulo Pharmaceuticals: lead

Study Sites (1)

University of Massachusetts Memorial Children's Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for measurement of cannabinoid and metabolite concentrations in plasma.

Study Officials

• Ken Cundy, PhD

  Anebulo Pharmaceuticals Inc.

  STUDY DIRECTOR

Central Study Contacts

Linda Klumpers, PhD

CONTACT

512-598-0931; linda@anebulo.com

Ken Cundy, PhD

CONTACT

512-598-0931; ken@anebulo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)