Text Size

Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00338546
First received: June 16, 2006
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cocaine and Sympathetic Nerve Activity in Humans

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00338546     History of Changes
Other Study ID Numbers: 2RO1DA01006409
Study First Received: June 16, 2006
Last Updated: May 19, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cocaine
Dexmedetomidine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 16, 2013