Benadryl brain study halted after just 3 volunteers

NCT ID NCT05219604

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study aimed to measure how a single IV dose of diphenhydramine (Benadryl) affects thinking, memory, and alertness over time. Researchers planned to compare effects in middle-aged and older adults. However, the study was terminated early after enrolling only 3 participants, so the findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diphenhydramine (Benadryl)
What this could lead to
If successful, this could help doctors better understand how antihistamines like diphenhydramine affect thinking and alertness, especially in older adults.
What could go wrong
The study was terminated early and only enrolled 3 people, so results are very limited and may not apply to the general population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States