Assessment of Drug Liking In Peri-procedural Clinical Settings

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Droperidol
  Medication administered as a single intravenous dose.
• Препарат Placebo
  Matching Placebo given by single intravenous (IV) administration.

Первичные конечные точки

• Change in Drug Liking Rating [Срок оценки: One minute before and 1, 3, and 5 minutes after fentanyl administration]

Вторичные конечные точки (2)

• EEG band power [Срок оценки: From administration of the study drug to about 1 hour after.]
• Change in Sedation Rating [Срок оценки: One minute before and 1, 3, and 5 minutes after fentanyl administration]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Current use of antiemetic medication (i.e., 5HT or dopamine antagonists)
• Active seizure disorder
• Active mental health disorders resulting in functional impairment
• Current use of psychostimulant medications (Adderall)
• Current use of CNS depressants (e.g., barbiturates, benzodiazepines)
• Severe renal insufficiency (Stage 4 or 5)
• Impaired cognitive function
• Regular Cannabis use (2+ times per week)
• Current history of substance abuse disorder.
• Failure to satisfy the investigator of fitness to participate for any other reason

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Stanford Hospital — Palo Alto

Идентификаторы

NCT: NCT07015528 · IRB-74179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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