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

NCT ID: NCT05219604

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-10-04

Brief Summary

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

Conditions

Central Nervous System Effects of Diphenhydramine; Pharmacokinetics of Diphenhydramine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

DiphenhydrAMINE Injectable Solution

Intravenous infusion of diphenhydramine 50 mg.

Intervention Type: DRUG

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dent Neuroscience Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Rainka, PharmD

Role: PRINCIPAL_INVESTIGATOR

Dent Neurologic Institute

Locations

Dent Neurologic Institute

Amherst, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DIP-PKPD

Identifier Type: -

Identifier Source: org_study_id