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Evidence of Haloperidol Absorption After Topical Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684969
Recruitment Status : Withdrawn (lack of accrual and funding is about to expire.)
First Posted : September 13, 2012
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Eric E. Prommer, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Haloperidol Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Haloperidol: Evidence of Absorption After Topical Administration
Study Start Date : March 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: intravenous haloperidol
intravenous haloperidol pharmacokinetics
Drug: Haloperidol
0.5 mg iv x one dose

Placebo Comparator: Placebo Drug: Placebo
0.5 mg iv , one dose

Primary Outcome Measures :
  1. To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration. [ Time Frame: baseline to 240 minutes after administration. ]
    Measuring either the presence of absence of haloperidol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684969

Sponsors and Collaborators
Eric E. Prommer
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Principal Investigator: Eric Prommer, MD Mayo Clinic

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Responsible Party: Eric E. Prommer, Assistant Professor of Medicine, College of Medicine, Mayo Clinic Identifier: NCT01684969    
Other Study ID Numbers: 11-005661
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Eric E. Prommer, Mayo Clinic:
gastrointestinal symptoms
palliative care
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents