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Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01204255
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : August 5, 2011
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society, Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: lorazepam Drug: diphenhydramine hydrochloride Drug: haloperidol Other: questionnaire administration Other: laboratory biomarker analysis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : November 15, 2010
Actual Primary Completion Date : April 18, 2011
Actual Study Completion Date : May 17, 2011


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Lorazepam, Diphenyhydramine, Haloperidol Absorption [ Time Frame: 4 hours ]
    Level of lorazepam absorption measured by the serum concentration of the drug


Secondary Outcome Measures :
  1. Side Effects [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01204255     History of Changes
Other Study ID Numbers: MCC-13108
NCI-2010-01968 ( Registry Identifier: CTRP )
PEP-10-174-1-PCSM ( Other Grant/Funding Number: American Cancer Society )
First Posted: September 17, 2010    Key Record Dates
Results First Posted: August 5, 2011
Last Update Posted: November 17, 2017
Last Verified: October 2017

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

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