Clinical trial NCT05219604: Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Official title: The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Central Nervous System Effects of Diphenhydramine
Pharmacokinetics of Diphenhydramine
Lead sponsor: Dent Neuroscience Research Center
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 3
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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
11. Female subjects of childbearing potential unwilling to use acceptable method of contraception during the study as defined in the protocol
12. Contraindication, known allergy, or suspected intolerability to study medication
13. Receipt of an antihistamine within 5 half-lives prior to the start of study visit 1 or study visit 2, as determined by the investigator
14. Positive toxicology test for a drug that is inconsistent with permitted medication use (defined in the protocol) as interpreted by the investigator
15. Participation in any other investigational drug study during the study or within 4 weeks prior to screening

Primary outcomes:
measure: Change in score of battery of cognitive function tests
timeFrame: Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)
Secondary outcomes:
measure: Elderly vs. adult score of battery of cognitive function tests at specified time points
timeFrame: Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)
measure: Elderly vs. adult diphenhydramine AUC
timeFrame: Immediately after diphenhydramine administration to 480 minutes after diphenhydramine administration
measure: Elderly vs. adult change in score of battery of cognitive function tests after diphenhydramine
timeFrame: After diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
Study officials:
affiliation: Dent Neurologic Institute
name: Michelle Rainka, PharmD
role: PRINCIPAL_INVESTIGATOR
References: