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

• Sponsor: Dent Neuroscience Research Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05219604
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Anticipated Duration (Months): 11.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Effects of Diphenhydramine; Pharmacokinetics of Diphenhydramine	Drug: DiphenhydrAMINE Injectable Solution	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dent Neurologic Institute	Amherst	New York	United States	14226

Sponsors and Collaborators

• Dent Neuroscience Research Center

Investigators

• Principal Investigator: Michelle Rainka, PharmD, Dent Neurologic Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dent Neuroscience Research Center
• ClinicalTrials.gov Identifier: NCT05219604
• Other Study ID Numbers: DIP-PKPD
• First Posted: Feb 2, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Diphenhydramine; Promethazine

Study Results

No Results Posted as of Mar 18, 2022