Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression (NCT06017622) | Clinical Trial Compass
RecruitingNot Applicable
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
United States36 participantsStarted 2023-06-01
Plain-language 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 pediatric patients who visit the emergency department due to acute cannabis-induced CNS depression.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Inclusion Criteria:The patient is younger than 18 years old.
. 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:
. Blood samples are taken as part of routine clinical procedures, or the patient has an IV line through which blood can be taken.
. The LAR is willing and able to provide consent.
. The patient is willing and able to provide assent, if applicable and feasible, based on age and clinical condition.
Exclusion criteria
. 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.
. 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.
. Patient presenting with cannabis use disorder (CUD), cannabis hyperemesis syndrome (CHS) or cannabis withdrawal syndrome (CWS)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)