Assessment of Drug Liking In Peri-procedural Clinical Settings

NCT07015528 | Enrolling By Invitation Early Phase 1 FDA Drug

• 1 other identifier: IRB-74179
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Liking

Outcome Measures

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".

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

Secondary Outcomes (2)

• EEG band power

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

• Change in Sedation Rating

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

Study Arms (2)

Droperidol

EXPERIMENTAL

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

Drug: Droperidol

Placebo

PLACEBO COMPARATOR

Participants receive placebo prior to fentanyl administration before their procedure.

Drug: Placebo

Interventions

Droperidol DRUG

Medication administered as a single intravenous dose.

Droperidol

Placebo DRUG

Matching Placebo given by single intravenous (IV) administration.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Droperidol

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Patrick L Purdon, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)