Recruiting

Observational Study

Sponsor:

Anebulo Pharmaceuticals

Code:

NCT06017622

Conditions

Acute Cannabis-induced CNS Depression

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06017622

Start date

Jun 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

All subjects

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

Primary outcome measure

  • Plasma Concentration of delta-9 tetrahydrocannabinol (THC) [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

University of Massachusetts Memorial Children's Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Principal Investigator:

Zachary W. Binder, MD

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Melinda Mahabee-Gittens, MD, PhD

513-636-7966Melinda.Mahabeegittens@cchmc.org

Principal Investigator:

Melinda Mahabee-Gittens, MD, PhD

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97329

Contacts

Robert G. Hendrickson, MD, FACMT

503-494-9495hendriro@ohsu.edu

Principal Investigator:

Robert G. Hendrickson, MD, FACMT

More Information

Sponsor

Anebulo Pharmaceuticals

Last update posted

Jul 30, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anebulo Pharmaceuticals on 2026-07-30.