Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

N/ACompletedNCT01204255

Virginia Commonwealth University11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

lorazepamDRUG

Given topically

diphenhydramine hydrochlorideDRUG

Given topically

haloperidolDRUG

Given topically

questionnaire administration

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Lorazepam, Diphenyhydramine, Haloperidol Absorption

Level of lorazepam absorption measured by the serum concentration of the drug

Time frame: 4 hours

Secondary Outcomes

Side Effects

Time frame: 3 months

Data from ClinicalTrials.gov

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