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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study measures THC and the substances the body makes as it breaks down THC in blood samples. THC is a chemical in cannabis. The study is for children and teens in the emergency room with suspected cannabis effects that slow brain activity, such as extreme sleepiness or slow breathing.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The patient is younger than 18.
  • The patient comes to the emergency room with serious slowing of brain activity thought to be caused by cannabis.
  • The patient had cannabis or a product with similar effects, such as delta-8 THC or HHC, within the past 12 hours. This is supported by a drug test or other reliable evidence, such as a caregiver’s report or product packaging.
  • Symptoms started during or soon after cannabis exposure and are linked to it, OR the study clinician judges that the symptoms fit sudden cannabis-related slowing of brain activity.
  • Blood is being drawn for regular care, or the patient has an IV line that can be used to draw blood.
  • A person legally allowed to give permission for the patient is willing and able to do so.
  • The patient agrees to join if their age and health allow them to do so.

Who can't join

  • The study leader believes something would raise the patient’s risk or keep them from following or finishing the study.
  • Another health condition, mental health condition, or drug better explains the symptoms, and the study leader judges that recent cannabis exposure did not cause them.
  • The patient has cannabis use disorder, meaning trouble controlling cannabis use.
  • The patient has cannabis hyperemesis syndrome, which causes repeated vomiting linked to cannabis use.
  • The patient has cannabis withdrawal syndrome, meaning symptoms from stopping or cutting back on cannabis.
  • The patient is brought in by police, such as after a vehicle crash involving driving under the influence of cannabis.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

MA

OH

OR