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Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00338546
First Posted: June 20, 2006
Last Update Posted: May 21, 2009
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Texas Southwestern Medical Center
  Purpose
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 Intervention Phase
Cocaine Induced Sympathoexciation and Vasoconstriction Drug: Cocaine hydrochloride Drug: Dexmedetomidine Procedure: Microneurography Procedure: Laser doppler velocimetry Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Cocaine and Sympathetic Nerve Activity in Humans

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Blood pressure
  • Heart rate
  • Skin sympathetic nerve activity
  • Skin blood flow
  • Coronary blood flow

Secondary Outcome Measures:
  • Sedation status

Estimated Enrollment: 440
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00338546


Contacts
Contact: Wapen Vongpatanasin, MD 214-648-9078 wanpen.vongpatanasin@utsouthwestern.edu
Contact: Dileep V Menon, MD 214-648-7941 dileep.menon@utsouthwestern.edu

Locations
United States, Texas
Univ of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Wanpen Vongpatanasin, MD    214-648-9078    wanpen.vongpatanasin@utsouthwestern.edu   
Contact: Dileep V Menon, MD    214-648-7941    dileep.menon@utsouthwestern.edu   
Principal Investigator: Ronald G Victor, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ronald G Victor, MD Univ of Texas Southwestern Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00338546     History of Changes
Other Study ID Numbers: 2RO1DA01006409
First Submitted: June 16, 2006
First Posted: June 20, 2006
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by University of Texas Southwestern Medical Center:
Cocaine
Sympathetic nerve activity
Blood pressure
Cutaneous vasoconstriction
Coronary vasoconstriction

Additional relevant MeSH terms:
Dexmedetomidine
Cocaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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
Anesthetics
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents