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Enrolling by invitationNCT07015528Updated Sep 30, 2026

Assessment of Drug Liking In Peri-procedural Clinical Settings

An Early Phase 1 interventional study of Droperidol and Placebo in Drug Liking, sponsored by Stanford University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Stanford University · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Drug Liking
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
04

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Droperidol

    Participants receive study drug prior to fentanyl administration before their procedure.

    Drug: Droperidol

  • Placebo comparator
    Placebo

    Participants receive placebo prior to fentanyl administration before their procedure.

    Drug: Placebo

Interventions

  • DrugDroperidol

    Medication administered as a single intravenous dose.

  • DrugPlacebo

    Matching Placebo given by single intravenous (IV) administration.

05

What researchers measure

Primary outcomes

  1. 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".

    Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration

Secondary outcomes

  1. EEG band power

    Assessment of the change in power of the frontal EEG canonical frequency bands measured in decibeles (dB).

    Time frame: From administration of the study drug to about 1 hour after.

  2. 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".

    Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration

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Study locations

1 site
  • Stanford Hospital
    Palo Alto, California 94304, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07015528
Lead sponsor
Stanford University
Responsible party
Patrick Purdon (Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University) — Principal investigator
First posted
Jun 11, 2025
Start date
Sep 30, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Patrick L Purdon, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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