Status:
ACTIVE_NOT_RECRUITING
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
Lead Sponsor:
Anebulo Pharmaceuticals
Conditions:
Acute Cannabinoid Intoxication
Eligibility:
All Genders
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject visits emergency department for acute cannabinoid intoxication as evidenced by the following criteria:
- Recent cannabis use within the last 12 hours
- 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
- 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.
- 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:
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Individuals under the age of 18 who do not have a parent or legal representative present during the time at the ED.
- Patients presenting with signs or symptoms attributable to another medical condition or better explained by another mental disorder.
- Patient presenting with 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).
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06017622
Start Date
June 1 2023
End Date
June 30 2026
Last Update
October 20 2025
Active Locations (4)
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1
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
3
Oakland University William Beaumont School of Medicine
Royal Oak, Michigan, United States, 48073
4
University of Vermont Medical Center
Burlington, Vermont, United States, 05401