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Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society, Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01204255
First received: September 15, 2010
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.
 Drug: lorazepam
Drug: diphenhydramine hydrochloride
Drug: haloperidol
Other: questionnaire administration
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Lorazepam, Diphenyhydramine, Haloperidol Absorption [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Level of lorazepam absorption measured by the serum concentration of the drug


Secondary Outcome Measures:
  • Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
 Drug: lorazepam
Given topically
Other Name: 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
Other: questionnaire administration
Ancillary studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204255

Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
American Cancer Society, Inc.
Investigators
Principal Investigator: Thomas Smith Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01204255     History of Changes
Other Study ID Numbers: MCC-13108, NCI-2010-01968, PEP-10-174-1-PCSM
Study First Received: September 15, 2010
Results First Received: July 11, 2011
Last Updated: April 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
healthy, no evidence of disease

Additional relevant MeSH terms:
Diphenhydramine
Haloperidol
Lorazepam
Promethazine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on May 23, 2013