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

Phase 4

Terminated

• Conditions: Central Nervous System Effects of Diphenhydramine; Pharmacokinetics of Diphenhydramine

• Registration Number: NCT05219604
• Lead Sponsor: Dent Neuroscience Research Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-02
• Study Start: 2022-03-15
• Primary Completion: 2022-10-04
• Study Completion: 2022-10-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in score of battery of cognitive function tests	Change from before to after diphenhydramine administration (30, 60, 210, 240, 450, and 480 minutes after diphenhydramine)	Change in the results of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation after diphenhydramine administration compared to baseline

Secondary Outcome Measures

Name	Time	Method
Elderly vs. adult change in score of battery of cognitive function tests after diphenhydramine	After diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)	Change in the score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration) compared to baseline.
Elderly vs. adult score of battery of cognitive function tests at specified time points	Before and after diphenhydramine administration (30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)	Score of the CANTAB battery of cognitive function tests (reaction time, rapid visual information processing, paired associates learning, spatial working memory, digit span) and visual analog scale for sedation in elderly subjects aged 65+ compared to adult subjects aged 35 to 50 at specified time points (0, 30, 60, 210, 240, 450, 480 minutes after diphenhydramine administration)
Elderly vs. adult diphenhydramine AUC	Immediately after diphenhydramine administration to 480 minutes after diphenhydramine administration	Difference between diphenhydramine pharmacokinetic area under the curve (AUC) in elderly subjects aged 65+ vs. adult subjects aged 35 to 50

Trial Locations

Locations (1)

Dent Neurologic Institute; 🇺🇸 Amherst, New York, United States