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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
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: June 16, 2006
Last updated: May 19, 2009
Last verified: May 2009
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-Blind
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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00338546

Contact: Wapen Vongpatanasin, MD 214-648-9078
Contact: Dileep V Menon, MD 214-648-7941

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00338546     History of Changes
Other Study ID Numbers: 2RO1DA01006409
Study First Received: June 16, 2006
Last Updated: May 19, 2009

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

Additional relevant MeSH terms:
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 processed this record on May 22, 2017