Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
Information source: Virginia Commonwealth University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy, no Evidence of Disease; Nausea and Vomiting
Intervention: lorazepam (Drug); diphenhydramine hydrochloride (Drug); haloperidol (Drug); questionnaire administration (Other); laboratory biomarker analysis (Other)
Status: Not yet recruiting
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: Level of drug absorption measured by the serum concentration of the drug
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.
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
Locations and Contacts
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia 23298, United States
Starting date: September 2010
Last updated: September 15, 2010