Healthy
Conditions
Keywords
healthy, no evidence of disease
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.
Interventions
DRUGlorazepam
Given topically
Given topically
DRUGhaloperidol
Given topically
OTHERquestionnaire administration
Ancillary studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
American Cancer Society, Inc.
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lorazepam, Diphenyhydramine, Haloperidol Absorption | 4 hours | Level of lorazepam absorption measured by the serum concentration of the drug |
Secondary
| Measure | Time frame |
|---|---|
| Side Effects | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Arm I |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 37.7 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Lorazepam, Diphenyhydramine, Haloperidol Absorption
Level of lorazepam absorption measured by the serum concentration of the drug
Time frame: 4 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Application of Lorazepam, Diphenhydramine, Haloperidol | Lorazepam, Diphenyhydramine, Haloperidol Absorption | lorazepam absorption | 0 ng/ml | Standard Deviation 0 |
| Application of Lorazepam, Diphenhydramine, Haloperidol | Lorazepam, Diphenyhydramine, Haloperidol Absorption | diphenhydramine absorption | .08 ng/ml | Standard Deviation 0.12 |
| Application of Lorazepam, Diphenhydramine, Haloperidol | Lorazepam, Diphenyhydramine, Haloperidol Absorption | haloperidol absorption | 0 ng/ml | Standard Deviation 0 |
Secondary
Side Effects
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Application of Lorazepam, Diphenhydramine, Haloperidol | Side Effects | 0 Total number of side effects |