Drug LikingEarly Phase 1NCT07015528
Assessment of Drug Liking In Peri-procedural Clinical Settings
A Early Phase 1 study testing Droperidol in people with Drug Liking, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Liking
- What is being tested?
- Droperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 30 Sep 2027
- Phase
- Early Phase 1
- 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
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- Candidates who are expected to receive fentanyl up to 3 mcg/kg IBW for their scheduled for surgery or procedure
Who cannot join
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- Allergies or hypersensitivities to droperidol or fentanyl
- Clinically significant pulmonary disease, such as chronic obstructive lung disease requiring long-term oxygen therapy, or other conditions that, in the study team's judgment, may increase the risk of severe respiratory depression with opioid administration
- History of long QT syndrome
Show all 27Show fewer
- History of Torsades de Pointes
- History of psychosis
- History of movement disorders e.g. Parkinson's Disease
- Past chronic use of anti-psychotics
- Current use of droperidol, levodopa, lithium, clozapine, metoclopramide, benzodiazepines
- Current use of opioids
- 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
- History of pheochromocytoma
- History of concomitant prolactin-dependent tumors e.g. prolactinoma, breast cancer
- Pregnancy or nursing
- Current use of antiemetic medication (i.e., 5HT or dopamine antagonists)
- Active seizure disorder
- Active mental health disorders resulting in functional impairment
- Current use of psychostimulant medications (Adderall)
- Current use of CNS depressants (e.g., barbiturates, benzodiazepines)
- Severe renal insufficiency (Stage 4 or 5)
- Impaired cognitive function
- Regular Cannabis use (2+ times per week)
- Current history of substance abuse disorder.
- Failure to satisfy the investigator of fitness to participate for any other reason
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 purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
Read the detailed description
Specifically, we aim to measure differences in drug liking with a VAS (0 - 100) questionnaire. Additionally, we will monitor neural activity recording a frontal electroencephalogram (EEG) to detect changes in brain signals associated with opioid drug effects. By comparing behavioral and neurophysiological data across treatment and control groups, this study seeks to explore the therapeutic potential of this medication.
- Conditions
- Drug Liking
- Being tested
- Droperidol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroperidolDrug
Medication administered as a single intravenous dose.
PlaceboDrug
Matching Placebo given by single intravenous (IV) administration.
| Study group | Role | What they receive |
|---|---|---|
| Droperidol | Experimental | Participants receive study drug prior to fentanyl administration before their procedure. Receives: Drug: Droperidol |
| Placebo | Placebo comparator | Participants receive placebo prior to fentanyl administration before their procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drug Liking Rating
Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
Measured: One minute before and 1, 3, and 5 minutes after fentanyl administration
Secondary outcomes (2)
EEG band power
Assessment of the change in power of the frontal EEG canonical frequency bands measured in decibeles (dB).
Measured: From administration of the study drug to about 1 hour after.
Change in Sedation Rating
Change in self-reported sedation rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
Measured: One minute before and 1, 3, and 5 minutes after fentanyl administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug LikingStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Purdon, Stanford University
- Investigators
- Patrick L Purdon, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015528
- Sponsor's protocol ID
- IRB-74179
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Drug Liking In Peri-procedural Clinical Settings
- ClinicalTrials.gov ID
- NCT07015528
- Acronym / sponsor ID
- IRB-74179
- Conditions
- Drug Liking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Jun 2025 (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 purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
Detailed description
Specifically, we aim to measure differences in drug liking with a VAS (0 - 100) questionnaire. Additionally, we will monitor neural activity recording a frontal electroencephalogram (EEG) to detect changes in brain signals associated with opioid drug effects. By comparing behavioral and neurophysiological data across treatment and control groups, this study seeks to explore the therapeutic potential of this medication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Droperidol | Experimental | Drug: DroperidolParticipants receive study drug prior to fentanyl administration before their procedure. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo prior to fentanyl administration before their procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- Candidates who are expected to receive fentanyl up to 3 mcg/kg IBW for their scheduled for surgery or procedure
Key exclusion criteria (27 listed)
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- Allergies or hypersensitivities to droperidol or fentanyl
- Clinically significant pulmonary disease, such as chronic obstructive lung disease requiring long-term oxygen therapy, or other conditions that, in the study team's judgment, may increase the risk of severe respiratory depression with opioid administration
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 |
|---|---|---|
| DroperidolMedication administered as a single intravenous dose. | Drug | Droperidol |
| PlaceboMatching Placebo given by single intravenous (IV) administration. | Drug | Placebo |
Primary outcome
Change in Drug Liking Rating
Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration
Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
2 secondary outcomes
EEG band power
Time frame: From administration of the study drug to about 1 hour after.
Change in Sedation Rating
Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration
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 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Patrick L Purdon, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Droperidol in people with 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 2 inclusion and 27 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 30 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Drug Liking Rating (time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration). 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 Sep 2026.