Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Healthy

Treatments

Drug: lorazepam

Other: questionnaire administration

Drug: haloperidol

Other: laboratory biomarker analysis

Drug: diphenhydramine hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01204255

PEP-10-174-1-PCSM (Other Grant/Funding Number)

MCC-13108

NCI-2010-01968 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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