- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06699953
Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
May 6, 2026 updated by: Patrick Purdon, Stanford University
The goal of this study is to characterize an electroencephalogram (EEG) biomarker for fentanyl and understand where this signal is coming from in the brain.
The investigators also aim to understand how this EEG biomarker is connected to patient perception to drug liking.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford Hospital
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patients scheduled for general surgical procedures under general anesthesia
Description
Inclusion Criteria:
- 18 years old or above (male and female)
- American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- Candidates scheduled for general surgical procedures under general anesthesia and receive fentanyl for surgery
Exclusion Criteria:
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- Body mass index above 45 kg/m2
- Allergies to fentanyl
- History of obstructive sleep apnea requiring CPAP
- History of obstructive or restrictive lung disease
- Opiate use within 24 hours
- History of opiate abuse within the last 3 years
- Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
- MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Source Localization of Fentanyl EEG Signature
Time Frame: 15 minutes prior to surgery
|
The investigators will perform high density electroencephalogram to estimate the power and source localization of canonical (delta, theta, alpha, gamma and beta) bands power to determine the likely generators for the fentanyl EEG signature.
|
15 minutes prior to surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration
Time Frame: 15 minutes prior to surgery
|
The investigators will use a linear mixed-effects model to characterize the relationship between the fentanyl EEG signature and fentanyl predicted effect site concentrations derived from pharmacokinetic models.
|
15 minutes prior to surgery
|
|
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature
Time Frame: 15 minutes before the surgery
|
The investigators will use a linear mixed-effects model to characterize the relationship between the VAS (0 - 100) liking rating and the fentanyl EEG signature.
|
15 minutes before the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
February 4, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
November 19, 2024
First Submitted That Met QC Criteria
November 19, 2024
First Posted (Actual)
November 21, 2024
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-77223
- R01DA056593 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Activity Related to Opioid Administration
-
University of ZurichETH Zurich, Human Nutrition LaboratoryCompletedStudy Not Related to a Disease. Nutrition Study Without Drug Administration.Switzerland
-
University of California, San DiegoNot yet recruitingPain Related to Local Anesthetic Administration for Nexplanon Placement
-
University Hospital, Basel, SwitzerlandCompletedShoulder Injury Related to Vaccine Administration | Erosion, LocalizedSwitzerland
-
University of ThessalyGeneral Hospital of Larissa; General Hospital of Trikala; National Organization... and other collaboratorsRecruitingIncarceration | Non-communicable Diseases (NCD) | Addiction to Opioids | Opioid-use DisordersGreece
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Columbia University; Weill Medical College... and other collaboratorsEnrolling by invitationOpioid Use | Opioid Court Model | Medication to Treat Opioid Use DisorderUnited States
-
Indivior Inc.Completed
-
Royal Victoria Hospital, CanadaNot yet recruitingModerate to Severe Opioid Use DisorderCanada
-
Indivior Inc.CompletedModerate to Severe Opioid-use DisorderUnited States, Canada
-
NYU Langone HealthNational Institutes of Health (NIH)RecruitingProblems Related to Social EnvironmentUnited States
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)Enrolling by invitationCarrying Naloxone/Narcan on Their Person or in Their Vehicle | Being Trained to Respond to an Opioid OverdoseUnited States
Clinical Trials on Observational study in patients receiving fentanyl for surgery
-
University Hospital Schleswig-HolsteinCompleted
-
Johnson & Johnson Taiwan LtdCompleted
-
Karolinska University HospitalKarolinska InstitutetCompletedInflammation | Surgery
-
Ferring PharmaceuticalsCompleted
-
Imperial College LondonActive, not recruitingCardiomyopathies | Implantable Defibrillator User | ICDUnited Kingdom
-
Maxima Medical CenterRadboud University Medical Center; Catharina Ziekenhuis Eindhoven; The Netherlands... and other collaboratorsRecruitingOvarian Cancer | Ovarian TumorNetherlands
-
Rambam Health Care CampusUnknownDetecting Abnormal Fetal Karyotype by the Electronic Nose
-
First Affiliated Hospital Xi'an Jiaotong UniversityActive, not recruiting
-
Beth Israel Deaconess Medical CenterBrigham and Women's HospitalActive, not recruitingAortic Valve Disease | Aortic Valve Insufficiency | Aortic Aneurysm | Aortic Diseases | Aortic Valve Calcification | Calcific Aortic Stenosis | Calcific Aortic Stenosis - Bicuspid Valve | Aortic Valve Cusp Abnormality | Aortic Valve Disease MixedUnited States
-
Western Regional Medical CenterUnknownEsophageal CancerUnited States