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Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling | Clinical Trials | Clareo Health

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Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling

The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling

NCT05219604•Dent Neuroscience Research Center

View on ClinicalTrials.gov

Summary

This study seeks to explore the magnitude and duration of central nervous system effects and pharmacokinetics after intravenous infusion of diphenhydramine.

Eligibility

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Medically-stable volunteers of either gender between 35 and 50 years old or over the age of 65
•2. No medication changes anticipated for the duration of the study except as defined in protocol

Exclusion Criteria

•1. Insulin-dependent diabetes
•2. Psychiatric or neurologic disease affecting cognition in a way that may interfere with study outcomes in the opinion of the investigator
•3. Unstable Coronary Artery Disease (active angina, MI within 6 months, stent placement within 6 months, cardiac surgery within 6 months)
•4. Estimated CrCl \< 30 mL/min using the Cockroft-Gault equation based on ideal body weight or total body weight
•5. Any malignancy actively being treated or not in remission
•6. Currently taking any CNS stimulant or depressant medications that may interfere with study outcomes in the opinion of the investigator unless using as defined in the protocol
•7. Positive toxicology test for marijuana at screening visit or visit 2 or using marijuana not as defined in the protocol
•8. Active or recent history of a substance use disorder within one year
•9. Any medical condition that in the opinion of the investigator would disqualify the subject from participation in the study
•10. Female subjects who are pregnant, planning to become pregnant, or breastfeeding on any study day
+5 more criteria

Locations (1)

Dent Neurologic Institute

Amherst, New York, United States

Key Dates

Start Date

March 15, 2022

Primary Completion Date

October 4, 2022

Completion Date

October 4, 2022

Last Updated

January 22, 2026

Enrollment

ACTUAL participants

Conditions

Central Nervous System Effects of DiphenhydraminePharmacokinetics of Diphenhydramine

Interventions

DiphenhydrAMINE Injectable Solution

DRUG