Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Study Overview
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Brief Summary
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RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

Detailed Description
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OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.

Official Title
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Absorption of ABH Gel (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: lorazepam
* Drug: diphenhydramine hydrochloride
* Drug: haloperidol
* Other: questionnaire administration
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed a medical screening questionnaire English speaking No allergies to the drugs Able to complete the forms If a woman of childbearing age, agree to use contraception Exclusion Criteria: History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age) Use of any medication that would contraindicate benzodiazepine administration Pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. | Drug: lorazepam<br>* Given topically<br>* Other names: Ativan;Drug: diphenhydramine hydrochloride<br>* Given topically<br>* Other names: SK-Diphenhydramine;Drug: haloperidol<br>* Given topically<br>* Other names: R-1625;Other: questionnaire administration<br>* Ancillary studies<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lorazepam, Diphenyhydramine, Haloperidol Absorption | Level of lorazepam absorption measured by the serum concentration of the drug | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, no evidence of disease