Clinical trial NCT00338546: Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine
Official title: Cocaine and Sympathetic Nerve Activity in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cocaine Induced Sympathoexciation and Vasoconstriction
Keywords: Cocaine
Sympathetic nerve activity
Blood pressure
Cutaneous vasoconstriction
Coronary vasoconstriction
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Blood pressure
measure: Heart rate
measure: Skin sympathetic nerve activity
measure: Skin blood flow
measure: Coronary blood flow
Secondary outcomes:
measure: Sedation status
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Univ of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Univ of Texas Southwestern Medical Center
name: Ronald G Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/01.cir.100.5.497.
citation: Kontak AC, Victor RG, Vongpatanasin W. Dexmedetomidine as a novel countermeasure for cocaine-induced central sympathoexcitation in cocaine-addicted humans. Hypertension. 2013 Feb;61(2):388-94. doi: 10.1161/HYPERTENSIONAHA.112.203554. Epub 2013 Jan 2.
citation: 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. doi: 10.1016/j.jacc.2007.03.060. Epub 2007 Jul 30.