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Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

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: NCT00338546
Recruitment Status : Withdrawn
First Posted : June 20, 2006
Last Update Posted : January 16, 2019
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is to improve the scientific understanding of the cardiovascular actions of cocaine, in particular the ability of cocaine to increase blood pressure.

Condition or disease Intervention/treatment Phase
Cocaine Induced Sympathoexciation and Vasoconstriction Drug: Cocaine hydrochloride Drug: Dexmedetomidine Procedure: Microneurography Procedure: Laser doppler velocimetry Phase 1

Detailed Description:
Cocaine abuse has emerged as a major cause of life-threatening cardiovascular emergencies but our understanding of the underlying mechanisms mediating the adverse effects of cocaine is far from complete. Our previous studies in cocaine-naive human subjects have demonstrated that intranasal cocaine acutely stimulates the human cardiovascular system by a novel central mechanism of action.We are currently investigating a central sympatholytic drug,dexmedetomidine, in reversing the sympathomimetic effects (increase in blood pressure, heart rate and coronary vasoconstriction) of intranasal cocaine.This drug may be a new pharmacologic agent in the treatment of acute cocaine intoxication in humans.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cocaine and Sympathetic Nerve Activity in Humans

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Blood pressure
  2. Heart rate
  3. Skin sympathetic nerve activity
  4. Skin blood flow
  5. Coronary blood flow

Secondary Outcome Measures :
  1. Sedation status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Cocaine naive healthy volunteers

Exclusion Criteria:

  • Any evidence of cardiopulmonary disease by history or physical examination
  • History of hypertension or 24 hour blood pressure averaging >135/85 mmHg
  • Any history of substance abuse (other than tobacco)
  • Diabetes mellitus or other systemic illness
  • Individuals with a history of pseudocholinesterase deficiency
  • Pregnancy

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): NCT00338546

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United States, Texas
Univ of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Ronald G Victor, MD Univ of Texas Southwestern Medical Center
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00338546    
Other Study ID Numbers: 2RO1DA01006409
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by University of Texas Southwestern Medical Center:
Sympathetic nerve activity
Blood pressure
Cutaneous vasoconstriction
Coronary vasoconstriction
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents