Clinical trial NCT06017622: Observational Study of THC Concentrations in Acute Cannabinoid Intoxication
Official title: Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Subjects Visiting Emergency Departments for Acute Cannabinoid Intoxication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Cannabinoid Intoxication
Lead sponsor: Anebulo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients of any age and sex who present to an emergency department with acute cannabinoid intoxication.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Oakland University William Beaumont School of Medicine
state: Michigan
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Anebulo Pharmaceuticals Inc.
name: Ken Cundy, PhD
role: STUDY_DIRECTOR
References: