Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
Information source: Virginia Commonwealth University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.
Intervention: lorazepam (Drug); diphenhydramine hydrochloride (Drug); haloperidol (Drug); questionnaire administration (Other); laboratory biomarker analysis (Other)
Sponsored by: Virginia Commonwealth University
Official(s) and/or principal investigator(s):
Thomas Smith, Principal Investigator, Affiliation: Virginia Commonwealth University
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.
Official title: Absorption of "ABH Gel" (AtivanŽ, Lorazepam; BenadrylŽ, Diphenhydramine; and HaldolŽ, Haloperidol Gel) From the Skin of Normal Volunteers
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Lorazepam, Diphenyhydramine, Haloperidol Absorption
Secondary outcome: Side Effects
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia 23298, United States
Starting date: November 2010
Last updated: April 26, 2013