Brain Activity Related to Opioid AdministrationNCT06699953
Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
An observational study of Brain Activity Related to Opioid Administration and Brain Activity Related to Drug Liking, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Activity Related to Opioid Administration, Brain Activity Related to Drug Liking
- What is being tested?
- Observational study in patients receiving fentanyl for surgery
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for general surgical procedures under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Observational study in patients receiving fentanyl for surgery
- Keywords
- opioid crisis, neuroscience, EEG, drug liking, fentanyl, anesthesia, general anesthesia, opioids, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study in patients receiving fentanyl for surgeryOther
This observational study enrolls patients receiving fentanyl, a drug routinely administered during surgery under general anesthesia. The primary difference in the investigators' research protocol is the inclusion of a 5-minute interval between fentanyl administration and the induction of general anesthesia. Fentanyl will be given in two boluses of 2 mcg/kg (ideal body weight), spaced 2 minutes apart, totaling 4 mcg/kg. If the participant remains conscious, an additional 2 mcg/kg bolus will be administered after 2 minutes. Additionally, participants will complete a drug-liking questionnaire before the first bolus and every 30 seconds until anesthesia induction, rating how much they "liked" the drug on a 0-100 scale.
What is being measured
The primary outcome is the main question the study is designed to answer.
Source Localization of Fentanyl EEG Signature
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.
Measured: 15 minutes prior to surgery
Secondary outcomes (2)
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration
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.
Measured: 15 minutes prior to surgery
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature
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.
Measured: 15 minutes before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start4 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Activity Related to Opioid AdministrationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Patrick Purdon, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699953
- Sponsor's protocol ID
- IRB-77223
- Other IDs
- R01DA056593
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balanza GA, Bharadwaj KM, Mullen AC, Beck AM, Work EC, McGovern FJ, Houle TT, Eric TP, Purdon PL. An electroencephalogram biomarker of fentanyl drug effects. PNAS Nexus. 2022 Aug 30;1(4):pgac158. doi: 10.1093/pnasnexus/pgac158. eCollection 2022 Sep.
PubMed 36329725
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the EEG Signature of Fentanyl and Its Association With Drug Liking
- ClinicalTrials.gov ID
- NCT06699953
- Acronym / sponsor ID
- IRB-77223
- Keywords
- opioid crisis, neuroscience, EEG, drug liking, fentanyl, anesthesia, general anesthesia, opioids
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for general surgical procedures under general anesthesia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 study in patients receiving fentanyl for surgeryThis observational study enrolls patients receiving fentanyl, a drug routinely administered during surgery under general anesthesia. The primary difference in the investigators' research protocol is the inclusion of a 5-minute interval between fentanyl administration and the induction of general anesthesia. Fentanyl will be given in two boluses of 2 mcg/kg (ideal body weight), spaced 2 minutes apart, totaling 4 mcg/kg. If the participant remains conscious, an additional 2 mcg/kg bolus will be administered after 2 minutes. Additionally, participants will complete a drug-liking questionnaire before the first bolus and every 30 seconds until anesthesia induction, rating how much they "liked" the drug on a 0-100 scale. | Other | – |
Primary outcome
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.
2 secondary outcomes
Relationship Between Fentanyl EEG Signature and Fentanyl Effect Site Concentration
Time frame: 15 minutes prior to surgery
Relationship Between Visual Analog Scale Liking Rating and Fentanyl EEG Signature
Time frame: 15 minutes before the surgery
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 8 May 2026.
- Background: PubMed 36329725Balanza GA, Bharadwaj KM, Mullen AC, Beck AM, Work EC, McGovern FJ, Houle TT, Eric TP, Purdon PL. An electroencephalogram biomarker of fentanyl drug effects. PNAS Nexus. 2022 Aug 30;1(4):pgac158. doi: 10.1093/pnasnexus/pgac158. eCollection 2022 Sep.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Activity Related to Opioid Administration and Brain Activity Related to Drug Liking, run by Stanford University 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 3 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 8 May 2026. 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?
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?
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?
Source Localization of Fentanyl EEG Signature (time frame: 15 minutes prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06699953, which also lists 1 linked publication.
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 8 May 2026.