Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01204255
• Collaborator: National Cancer Institute (NCI) (NIH), American Cancer Society, Inc. (Other)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• 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: Nov 15, 2010
• Actual Primary Completion Date: Apr 18, 2011
• Actual Study Completion Date: May 17, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.	Drug: lorazepam; Given topically; Other Names: 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

Outcome Measures

Primary Outcome Measures

1. Lorazepam, Diphenyhydramine, Haloperidol Absorption [4 hours]

   Level of lorazepam absorption measured by the serum concentration of the drug

Secondary Outcome Measures

1. Side Effects [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01204255
• Other Study ID Numbers: MCC-13108; NCI-2010-01968; PEP-10-174-1-PCSM
• First Posted: Sep 17, 2010
• Last Update Posted: Nov 17, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Virginia Commonwealth University: healthy, no evidence of disease
• Additional relevant MeSH terms: Diphenhydramine; Promethazine; Lorazepam; Haloperidol; Haloperidol decanoate

Study Results

Participant Flow

Arm/Group Title	Arm I
Arm/Group Description	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Period Title: Overall Study
STARTED	11
COMPLETED	10
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Arm I
Arm/Group Description	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.7 (13.5)
Sex: Female, Male (Count of Participants)
Female	9 81.8%
Male	2 18.2%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Lorazepam, Diphenyhydramine, Haloperidol Absorption
Description	Level of lorazepam absorption measured by the serum concentration of the drug
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Application of Lorazepam, Diphenhydramine, Haloperidol
Arm/Group Description	Topical application of lorazepam, diphenhydramine, haloperidol
Measure Participants	10
lorazepam absorption	0 (0)
diphenhydramine absorption	.08 (.12)
haloperidol absorption	0 (0)

2. Secondary Outcome

Title	Side Effects
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Application of Lorazepam, Diphenhydramine, Haloperidol
Arm/Group Description	Topical application of lorazepam, diphenhydramine, haloperidol
Measure Participants	10
Number [Total number of side effects]	0

Adverse Events

Time Frame	4 hours
Arm/Group Title	Arm I
Arm/Group Description	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
All Cause Mortality
	Arm I
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm I
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Arm I
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.