Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amisulpride, Placebo.
- Who it may be relevant to
- Registry conditions: Drug Liking. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Amisulpride
Medication administered as a single intravenous dose. - Drug Placebo
Matching Placebo given by single intravenous (IV) administration.
Primary outcome measures
- Change in Drug Liking Rating [Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration]
Secondary outcome measures (2)
- EEG band power [Time frame: From administration of the study drug to about 1 hour after.]
- Change in Sedation Rating [Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Stanford Hospital — Palo Alto
Identifiers
NCT: NCT07348172 · IRB-80824