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Enrolling By Invitation
NCT07015528
Assessment of Drug Liking In Peri-procedural Clinical Settings
Conditions: Drug Liking
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 130
Sponsor: Stanford University
Location: Stanford Hospital Palo Alto California
Summary
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
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 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
Source: ClinicalTrials.gov (NCT07015528). StuddyBuddy aggregates publicly available trial information.