Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

This study is currently recruiting participants.

Verified by University of Texas Southwestern Medical Center, May 2009

First Received: June 16, 2006 Last Updated: May 19, 2009 History of Changes

Sponsors and Collaborators:	University of Texas Southwestern Medical Center National Institute on Drug Abuse (NIDA)
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00338546

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Cocaine and Sympathetic Nerve Activity in Humans

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Dexmedetomidine Dexmedetomidine hydrochloride

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:

Vongpatanasin W, Mansour Y, Chavoshan B, Arbique D, Victor RG. Cocaine stimulates the human cardiovascular system via a central mechanism of action. Circulation. 1999 Aug 3;100(5):497-502.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Menon DV, Wang Z, Fadel PJ, Arbique D, Leonard D, Li JL, Victor RG, Vongpatanasin W. Central sympatholysis as a novel countermeasure for cocaine-induced sympathetic activation and vasoconstriction in humans. J Am Coll Cardiol. 2007 Aug 14;50(7):626-33. Epub 2007 Jul 30.

Study ID Numbers:	2RO1DA01006409
Study First Received:	June 16, 2006
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00338546 History of Changes
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

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Adrenergic Agonists
Anesthetics, Local

Dopamine
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Vasoconstrictor Agents
Dopamine Agents
Analgesics
Dexmedetomidine
Peripheral Nervous System Agents
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Adrenergic Agonists
Pharmacologic Actions

Anesthetics, Local
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Vasoconstrictor Agents
Dopamine Agents
Analgesics
Peripheral Nervous System Agents
Dexmedetomidine
Cocaine
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009