Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

Cocaine Induced Sympathoexciation and Vasoconstriction Clinical Trial

Official title:

Cocaine and Sympathetic Nerve Activity in Humans

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00338546
• Other study ID #: 2RO1DA01006409
• Status: Withdrawn
• Phase: Phase 1

Study information

• Verified date: January 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Induced Sympathoexciation and Vasoconstriction

Intervention

Drug:
• Cocaine hydrochloride

• Dexmedetomidine

Procedure:
• Microneurography

• Laser doppler velocimetry

Locations

Country	Name	City	State
United States	Univ of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure
Primary	Heart rate
Primary	Skin sympathetic nerve activity
Primary	Skin blood flow
Primary	Coronary blood flow
Secondary	Sedation status