Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cocaine Induced Sympathoexciation and Vasoconstriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cocaine hydrochloride

Intervention Type DRUG

Dexmedetomidine

Intervention Type DRUG

Microneurography

Intervention Type PROCEDURE

Laser doppler velocimetry

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes