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

Stanford University

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Drug Liking

Treatments: Drug: Placebo; Drug: Amisulpride

Study type: Interventional

Funder types: Other

Identifiers

NCT07348172

IRB-80824

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Description:

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

Treatment:

Drug: Amisulpride

Placebo

Placebo Comparator group

Description:

Participants receive placebo prior to fentanyl administration before their procedure.

Treatment:

Drug: Placebo