Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

October 16, 2017 updated by: Virginia Commonwealth University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Other: laboratory biomarker analysis
Correlative studies
Other: questionnaire administration
Ancillary studies
Drug: lorazepam
Given topically
Other Names:
  • Ativan
Drug: diphenhydramine hydrochloride
Given topically
Other Names:
  • Benadryl
  • Bendylate
  • Eldadryl
  • SK-Diphenhydramine
Drug: haloperidol
Given topically
Other Names:
  • Haldol
  • McN-JR-1625
  • R-1625

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Side Effects
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

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

Investigators

  • Principal Investigator: Thomas Smith, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2010

Primary Completion (Actual)

April 18, 2011

Study Completion (Actual)

May 17, 2011

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-13108
  • NCI-2010-01968 (Registry Identifier: CTRP)
  • PEP-10-174-1-PCSM (Other Grant/Funding Number: American Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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