Observational Study of THC Concentrations in Acute Cannabinoid Intoxication

Recruiting

• Conditions: Acute Cannabinoid Intoxication

• Registration Number: NCT06017622
• Lead Sponsor: Anebulo Pharmaceuticals

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 subjects who visit the emergency department due to acute cannabinoid intoxication.

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 subjects admitted to emergency departments with acute cannabinoid intoxication 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 Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Subject visits emergency department for acute cannabinoid intoxication as evidenced by the following criteria:

   1. Recent cannabis use within the last 12 hours
   2. Clinically significant physiological abnormalities associated with cannabis use or problematic behavioral or psychological changes (e.g., altered perception, impaired motor coordination, euphoria, anxiety, a sensation of slowed time, impaired judgment, social withdrawal) that developed during, or shortly after, cannabis use

2. Subject (and/or parent/LAR when required) has the ability to communicate with comprehension with the study personnel at the time of consent/assent and the gathering of data other than plasma samples.

3. Subject (and/or parent/LAR when required) is willing and able to provide informed consent/assent.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
2. Individuals under the age of 18 who do not have a parent or legal representative present during the time at the ED.
3. Patients presenting with signs or symptoms attributable to another medical condition or better explained by another mental disorder.
4. Patient presenting with cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS)
5. Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)	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 cannabinoid intoxication.

Trial Locations

Locations (4)

Oakland University William Beaumont School of Medicine; 🇺🇸 Royal Oak, Michigan, United States

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States