ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multi-center Observational Study of Plasma Concentrations of THC and Its Metabolites in Pediatric Patients Visiting Emergency Departments for Acute Cannabis-induced CNS Depression

Quick Facts

Study Start:2023-06-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06017622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.
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).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Ken Cundy, PhD

STUDY_DIRECTOR

Anebulo Pharmaceuticals Inc.

Study Locations (Sites)

University of Colorado School of Medicine

Aurora, Colorado, 80045

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Oakland University William Beaumont School of Medicine

Royal Oak, Michigan, 48073

United States

University of Vermont Medical Center

Burlington, Vermont, 05401

United States

Collaborators and Investigators

Sponsor: Anebulo Pharmaceuticals

Ken Cundy, PhD, STUDY_DIRECTOR, Anebulo Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Acute Cannabinoid Intoxication