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Antihistamine

Diphenhydramine for Heat Stroke (BENEXE2022 Trial)

Phase 4
Waitlist Available
Led By Nicholas Ravanelli, PhD
Research Sponsored by Lakehead University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
Awards & highlights

BENEXE2022 Trial Summary

This trial will investigate if taking antihistamine medication, like Benadryl®, can put people at increased risk of heat-related illness.

Eligible Conditions
  • Heat Stroke
  • Hyperhidrosis
  • Allergy or Hay Fever
  • Hyperthermia
  • Anticholinergic Syndrome

BENEXE2022 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sweating
Secondary outcome measures
Change in rectal temperature

BENEXE2022 Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention Order (Placebo - Diphenhydramine)Experimental Treatment2 Interventions
On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (~1.75 liters of oxygen consumption per minute) in ~28°C and 30% relative humidity
Group II: Intervention Order (Diphenhydramine -Placebo)Experimental Treatment2 Interventions
On separate days, participants will march on a treadmill for 60 minutes at a fixed rate of oxygen consumption (~1.75 liters of oxygen consumption per minute) in ~28°C and 30% relative humidity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
2002
Completed Phase 4
~1170
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Lakehead UniversityLead Sponsor
25 Previous Clinical Trials
4,073 Total Patients Enrolled
Nicholas Ravanelli, PhDPrincipal InvestigatorLakehead University
~8 spots leftby May 2025
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