Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2023-04-05
2023-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Order 1
Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm.
Pitocin
At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
Order 2
Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm.
Pitocin
At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
Interventions
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Pitocin
At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
Eligibility Criteria
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Inclusion Criteria
2. Fluent in English
3. Healthy
Exclusion Criteria
5. Acute or chronic pain
6. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
7. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
8. Unstable psychiatric conditions
9. Needle phobia or history of fainting
10. Current use of opiate medication(s)
11. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
12. Currently pregnant or pregnant within the last two years
13. Currently nursing or lactating
14. Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
15. Past or current history of hyponatremia or at risk for hyponatremia
16. Current use of thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, selective serotonin reuptake inhibitors, monoamine oxidase inhibitora, or the recreational drug ecstasy
17. Latex allergy
18 Years
65 Years
ALL
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Laura Case
Assistant Professor
Locations
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ACTRI
La Jolla, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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802467
Identifier Type: -
Identifier Source: org_study_id