Benadryl brain study halted after just 3 volunteers
NCT ID NCT05219604
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
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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 Hide 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
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Dent Neurologic Institute
Amherst, New York, 14226, United States