Drug Liking
Conditions
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.
Interventions
DRUGDroperidol
Medication administered as a single intravenous dose.
DRUGPlacebo
Matching Placebo given by single intravenous (IV) administration.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drug Liking Rating | One minute before and 1, 3, and 5 minutes after fentanyl administration | Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG band power | From administration of the study drug to about 1 hour after. | Assessment of the change in power of the frontal EEG canonical frequency bands measured in decibeles (dB). |
| Change in Sedation Rating | One minute before and 1, 3, and 5 minutes after fentanyl administration | Change in self-reported sedation rating (0-100), anchored by divert "not at all=0" and "as much as possible=100". |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPatrick L Purdon, PhD
Stanford University
Outcome results
None listed