NCT01927640

Dexmedetomidine for Reversal of Cocaine's Effects on the Heart

Study of Dexmedetomidine for the Reversal of Cocaine's Effects on Myocardial Perfusion

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will use myocardial contrast echocardiography performed during a continuous intravenous infusion of Definity microbubbles (Perflutren lipid microbubbles) to determine if dexmedetomidine (an intravenous central sympatholytic drug) can reverse all the cardiovascular effects of low-dose intranasal cocaine-including vasoconstriction in the coronary microcirculation-both in cocaine-naïve and non-treatment seeking cocaine-addicted subjects.

Detailed description

Each subject will be participating in three study visits: Screening Visit, Visit 1: a low-dose dobutamine visit and Visit 2: a low-dose cocaine visit. At the dobutamine visit, the subject will only receive low-dose dobutamine, which will be used as an internal inotropic/vasodilator control for cocaine. At the cocaine visit, the subject will receive low-dose intranasal cocaine followed by either the active study drug (dexmedetomidine) or an inactive placebo (saline). Both cocaine and dobutamine will increase myocardial contractility and oxygen demand, thereby stimulating metabolic vasodilation. If, as predicted, cocaine also causes α-adrenergic agonist in the coronary microcirculation, then myocardial blood flow should increase less with cocaine then with dobutamine for a given level of myocardial oxygen demand. We will study if dexmedetomidine, a central sympatholytic, can normalize this cocaine effect. We previously have used dobutamine as a comparator for cocaine in our research. At both visits, myocardial contrast echocardiography will be used to measure regional myocardial perfusion.

Conditions

• Chest Pain
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Dexmedetomidine (0.3-0.6 mcg/kg) infusion.
DRUG	Normal Saline	Normal saline infusion (10 cc)
DRUG	Intranasal cocaine	Intranasal cocaine (2 mg/kg)

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-01-15
• Completion: 2014-01-15
• First posted: 2013-08-22
• Last updated: 2020-01-14

Locations

1 site across 1 country: United States