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Enrolling by Invitation

NCT Number: NCT07015528

Assessment of Drug Liking In Peri-procedural Clinical Settings

The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.

Enrolling by Invitation

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Droperidol

Drug

Medication administered as a single intravenous dose.

Placebo

Drug

Matching Placebo given by single intravenous (IV) administration.

Primary outcomes

  1. 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".

Secondary outcomes

  1. EEG band power

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

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

  2. Change in Sedation Rating

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

    Change in self-reported sedation rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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