Drug OverdoseNCT04070521
EEG Monitoring in the Emergency Department
An observational study of Drug Overdose and Substance Abuse, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Overdose, Substance Abuse, Alcohol Abuse
- What is being tested?
- Observational EEG Monitoring
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse.
Who may be able to join
- Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse
Who cannot join
- Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient
- The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead
- The patient has dermatological issues or skin conditions on the forehead
- The patient has known dementia and/or mental impairment
- The patient is a prisoner
- The patient is an employee or student at one of the study sites.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Observational Study of EEG Monitoring of Patients in the Emergency Department
This study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.
- Conditions
- Drug Overdose, Substance Abuse, Alcohol Abuse
- Being tested
- Observational EEG Monitoring
- Keywords
- Electroencephalogram, Opioids, Alcohol, Benzodiazepines, Alpha-2 agonists, Propofol, Ketamine, Marijuana, Neuromechanisms of intoxicants
- Medical subject headings
- Drug Overdose, Substance-Related Disorders, Alcoholism, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational EEG MonitoringOther
Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose
| Study group | Role | What they receive |
|---|---|---|
| Observational EEG Monitoring | Not described Receives: Other: Observational EEG Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG)
Subject EEG activity following arrival to Emergency Department with suspected overdose, including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start6 Sep 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug OverdoseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Patrick L. Purdon, Massachusetts General Hospital
- Investigators
- Patrick L Purdon, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070521
- Sponsor's protocol ID
- 2018P002483
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of EEG Monitoring of Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT04070521
- Acronym / sponsor ID
- 2018P002483
- Conditions
- Drug Overdose, Substance Abuse, Alcohol Abuse
- Keywords
- Electroencephalogram, Opioids, Alcohol, Benzodiazepines, Alpha-2 agonists, Propofol, Ketamine, Marijuana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 28 Aug 2019 (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 study seeks to investigate whether drug effects in suspected overdose patients could be identified using the electroencephalogram (EEG). From previous work it is known that different classes of anesthetic drugs have specific "EEG signatures" related to the drug mechanisms. Many of the drugs of abuse that are frequently encountered in overdose patients are similar or identical to anesthetic drugs. The hypothesis for this study is that the EEG could be used to characterize the brain effects of intoxicants using EEG in the ED setting. Such monitoring could one day help clinicians and first responders at the point-of-care make more informed decisions to improve the care of overdose patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational EEG Monitoring | – | Other: Observational EEG Monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse.
Key inclusion criteria (1 listed)
- Adult patients aged 18 years and older who present to the ED with suspected use of a potential drug of abuse
Key exclusion criteria (6 listed)
- Hemodynamic instability or other acute medical condition for which the primary treating team does not thing it would be appropriate or safe for the study staff to approach the patient
- The patient has an overt head trauma or deformity of the face which would preclude application of the forehead EEG monitoring lead
- The patient has dermatological issues or skin conditions on the forehead
- The patient has known dementia and/or mental impairment
- The patient is a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational EEG MonitoringSubjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose | Other | Observational EEG Monitoring |
Primary outcome
Electroencephalogram (EEG)
Time frame: 24 hours
Subject EEG activity following arrival to Emergency Department with suspected overdose, including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
Related trials for Drug Overdose
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
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. This study is not recruiting at the moment.
Patrick L Purdon, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Overdose and Substance Abuse, run by Massachusetts General Hospital at 1 site 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram (EEG) (time frame: 24 hours). 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 1 Aug 2023.