Assessment of Drug Liking In Peri-procedural Clinical Settings

Early Phase 1

Not yet recruiting

• Conditions: Drug Liking
• Interventions: Drug: Droperidol; Drug: Placebo; Drug: Anti-dopaminergic Medication

• Registration Number: NCT07015528
• Lead Sponsor: Stanford University

Brief Summary

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-27
• Study Start: 2025-09-01
• Primary Completion: 2026-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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
• Failure to satisfy the investigator of fitness to participate for any other reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Droperidol	Droperidol	Participants receive study drug prior to fentanyl administration before their procedure.
Placebo	Placebo	Participants receive placebo prior to fentanyl administration before their procedure.
Antiemetic Medication	Anti-dopaminergic Medication	Participants receive antiemetic treatment prior to fentanyl administration before their procedure.
Placebo	Placebo	Participants receive placebo prior to fentanyl administration before their procedure.

Primary Outcome Measures

Name	Time	Method
Change in Drug Liking Rating	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 Outcome Measures

Name	Time	Method
EEG band power	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).
Change in Sedation Rating	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".

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Palo Alto, California, United States