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OpenTrials
Completed

NCT Number: NCT01204255

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorazepam

Drug

Given topically

Other names: Ativan

Diphenhydramine hydrochloride

Drug

Given topically

Other names: Benadryl, Bendylate, Eldadryl, SK-Diphenhydramine

Haloperidol

Drug

Given topically

Other names: Haldol, McN-JR-1625, R-1625

Questionnaire Administration

Other

Ancillary studies

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Lorazepam, Diphenyhydramine, Haloperidol Absorption

    Time frame: 4 hours

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

Secondary outcomes

  1. Side Effects

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Cancer Society, Inc.
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2010
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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