Assessment of Drug Liking In Peri-procedural Clinical Settings
Early Phase 1
Not yet recruiting
- Conditions
- Drug Liking
- Interventions
- Drug: Anti-dopaminergic MedicationDrug: Placebo
- Registration Number
- NCT07015528
- Lead Sponsor
- Stanford University
- Brief Summary
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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 (for example, endoscopies)
Exclusion Criteria.
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- 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 cardiac conduction disorders
- History of psychosis
- History of movement disorders e.g. Parkinson's Disease
- Past chronic use of anti-psychotics
- Current use of 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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiemetic Medication Anti-dopaminergic Medication Participants receive antiemetic treatment prior to fentanyl administration before their procedure. Placebo Placebo Participants receive placebo prior to fentanyl administration before their procedure.
- Primary Outcome Measures
Name Time Method Change in Drug Liking Rating Baseline (pre-intervention), and 1, 3, and 5 minutes following fentanyl administration Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford Hospital
🇺🇸Palo Alto, California, United States
Stanford Hospital🇺🇸Palo Alto, California, United States