Evidence of Haloperidol Absorption After Topical Administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

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This will be a blinded study to compare the absorption of topical haloperidol with placebo

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Detailed Description

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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intravenous haloperidol

intravenous haloperidol pharmacokinetics

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

0.5 mg iv x one dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.5 mg iv , one dose

Interventions

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Haloperidol

0.5 mg iv x one dose

Intervention Type DRUG

Placebo

0.5 mg iv , one dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: patient must be 18 years or older and less than 70 years of age.
* Provision of informed consent
* No previous adverse reaction to haloperidol
* No current use of haloperidol
* Good health
* No alcohol within 24 hours of the study
* No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
* Normal neurologic exam

Exclusionary Criteria

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
* Recent cerebral trauma
* Study will exclude women who are pregnant and/or nursing
* Women who are of child bearing potential must have a negative urine pregnancy test.
* History of seizures
* Taking medications that can interact with haloperidol
* Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes