Acute Cannabis-induced CNS DepressionNCT06017622
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
An observational study of Acute Cannabis-induced CNS Depression, run by Anebulo Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Cannabis-induced CNS Depression
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of pediatric patients under 18 years of age who present to an emergency department with acute cannabis-induced CNS depression .
Who may be able to join
- 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:
- 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
- Symptoms are associated with cannabis exposure and developed during, or shortly after, cannabis exposure;
- OR
Show all 10Show fewer
- 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).
- 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.
Who cannot join
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- 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)
- Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Melinda Mahabee-Gittens, MD, PhD, 513-636-7966, Melinda.Mahabeegittens@cchmc.org
Melinda Mahabee-Gittens, MD, PhD
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97329
Robert G. Hendrickson, MD, FACMT, 503-494-9495, hendriro@ohsu.edu
Robert G. Hendrickson, MD, FACMT
- Recruiting
University of Massachusetts Memorial Children's Medical Center
Worcester, Massachusetts, 01605
Zachary W. Binder, MD, (508) 334-6090, Zachary.binder@umassmemorial.org
Zachary W. Binder, MD
About this study
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
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.
Read the 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 pediatric patients admitted to emergency departments with acute cannabis-induced CNS depression. .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.
- Conditions
- Acute Cannabis-induced CNS Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | There is a single group consisting of all subjects who meet the eligibility criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabis induced CNS depression.
Measured: Day 1
Secondary outcomes (10)
Demographics
Describe the demographics of patients with acute cannabis-induced CNS depression
Measured: Baseline
Cannabis Exposure
Dose of cannabis ingested
Measured: Baseline
Cannabis-Related Symptoms
Clinical symptoms resulting from cannabis exposure
Measured: Baseline, 30 minutes, 1 hour, 6 hours
Richmond Agitation and Sedation (RASS) Score
The RASS evaluates a patient's level of agitation or sedation on a 10-point scale ranging from +4 (combative) to -5 (unarousable) with zero representing a calm, alert state
Measured: Baseline, 30 minutes, 1 hour, 6 hours
Glasgow Coma Scale (GCS) Score
The GCS assesses a patient's level of consciousness based on eye opening, verbal response, and motor response. The total score ranges from 3 (deep unconsciousness to 15 (fully alert)
Measured: Baseline, 30 minutes, 1 hour, 6 hours
Caregiver Global Impression of Change (CaGI-C)
The CaGI-C is completed by the caregiver or legally authorized representative and captures their overall impression of how the child's condition has changed since arrival at the emergency department. It will be measured using a 7-point Likert scale ranging from 1 (very much improved) to 7 (very much worse)
Measured: Baseline, 6 hours
Hospital or Intensive Care Unit Admission
This assesses whether the subject was admitted to the hospital or intensive care unit. It is a binary measure and can be yes or no.
Measured: From Enrollment Through Time of Discharge, up to 24 hours
Time to Discharge
This assesses the time from arrival at the emergency department until the subject is released. It is measured in minutes.
Measured: From Enrollment Through Time of Discharge, up to 24 hours
Need for Positive Pressure Ventilation
This is a binary assessment (yes or no) and captures whether the subject required ventilation assistance due to the cannabinoid exposure.
Measured: From Enrollment Through Time of Discharge, up to 24 hours
Occurrence of Seizures Requiring Intervention
This is a binary assessment (yes or no) and captures whether the subject experienced seizures which required intervention during the visit to the emergency department.
Measured: From Enrollment Through Time of Discharge, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cannabis-induced CNS DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anebulo Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Cundy, PhD, Study director, Anebulo Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017622
- Sponsor's protocol ID
- AN01AC01
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06017622
- Acronym / sponsor ID
- AN01AC01
- Conditions
- Acute Cannabis-induced CNS Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Anebulo PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pediatric patients admitted to emergency departments with acute cannabis-induced CNS depression. .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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | –There is a single group consisting of all subjects who meet the eligibility criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of pediatric patients under 18 years of age who present to an emergency department with acute cannabis-induced CNS depression .
Key inclusion criteria (10 listed)
- 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:
- AND EITHER
- OR
- Blood samples are taken as part of routine clinical procedures, or the patient has an IV line through which blood can be taken.
Key exclusion criteria (5 listed)
- A potential patient who meets any of the following criteria will be excluded from participation in this study:
- 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)
- Patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma Concentration of delta-9 tetrahydrocannabinol (THC)
Time frame: Day 1
Concentration of THC and THC metabolites (11-OH-THC and THC-COOH) in plasma of subjects admitted to emergency departments due to acute cannabis induced CNS depression.
10 secondary outcomes
Demographics
Time frame: Baseline
Cannabis Exposure
Time frame: Baseline
Cannabis-Related Symptoms
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Richmond Agitation and Sedation (RASS) Score
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Glasgow Coma Scale (GCS) Score
Time frame: Baseline, 30 minutes, 1 hour, 6 hours
Caregiver Global Impression of Change (CaGI-C)
Time frame: Baseline, 6 hours
Hospital or Intensive Care Unit Admission
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Time to Discharge
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Need for Positive Pressure Ventilation
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Occurrence of Seizures Requiring Intervention
Time frame: From Enrollment Through Time of Discharge, up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ken Cundy, PhD study director
Anebulo Pharmaceuticals Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cannabis-induced CNS Depression, run by Anebulo Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Klumpers, PhD (512-598-0931, linda@anebulo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of delta-9 tetrahydrocannabinol (THC) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.