Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: lorazepam; Drug: diphenhydramine hydrochloride; Drug: haloperidol; Other: questionnaire administration; Other: laboratory biomarker analysis

• Registration Number: NCT01204255
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-17
• Study Start: 2010-11-15
• Primary Completion: 2011-04-18
• Study Completion: 2011-05-17
• Results First Submitted: 2011-07-11
• Results First Submitted QC: 2011-07-11
• Results First Posted: 2011-08-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	laboratory biomarker analysis	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Arm I	diphenhydramine hydrochloride	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Arm I	questionnaire administration	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Arm I	lorazepam	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Arm I	haloperidol	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.

Primary Outcome Measures

Name	Time	Method
Lorazepam, Diphenyhydramine, Haloperidol Absorption	4 hours	Level of lorazepam absorption measured by the serum concentration of the drug

Secondary Outcome Measures

Name	Time	Method
Side Effects	3 months

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States