Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings

NCT ID: NCT07348172

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-03-31

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.

Conditions

Drug Liking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Drug

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

Group Type: EXPERIMENTAL

Amisulpride

Intervention Type: DRUG

Medication administered as a single intravenous dose.

Placebo

Participants receive placebo prior to fentanyl administration before their procedure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo given by single intravenous (IV) administration.

Interventions

Amisulpride

Medication administered as a single intravenous dose.

Intervention Type: DRUG

Placebo

Matching Placebo given by single intravenous (IV) administration.

Intervention Type: DRUG

Eligibility Criteria

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 amisulpride 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
• Any heart rhythm other than normal sinus rhythm (including but not limited to atrial fibrillation, atrial flutter, paced rhythms, ventricular tachycardia, or any supraventricular tachycardia)
• 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 amisulpride, 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Purdon

Professor of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Hospital

Palo Alto, California, United States

Countries

United States

Central Contacts

Patrick L Purdon, PhD

Role: CONTACT

ppurdon@stanford.edu

6507367331

Facility Contacts

Patrick Principal Investigator

Role: primary

ppurdon@stanford.edu

6179706739

Other Identifiers

IRB-80824

Identifier Type: -

Identifier Source: org_study_id