NCT01927640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2013

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2014

Completed
Last Updated

January 14, 2020

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

August 19, 2013

Last Update Submit

January 10, 2020

Conditions

Chest PainAcute Coronary Syndrome

Keywords

CocaineDexmedetomidineMyocardial Contrast Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Myocardial Perfusion

    Myocardial perfusion will be measured by myocardial contrast echocardiography after dexmedetomidine administration and compared to baseline. There will be no repeat dosing of dexmedetomidine. No longer term outcomes are measured.

    Baseline and Immediately after acute administration of study drug (Day 1)

Study Arms (2)

Dexmedetomidine and intranasal cocaine

EXPERIMENTAL

Intranasal cocaine administration (2 mg/kg) then Dexmedetomidine (0.3-0.6 mcg/kg) infusion

Drug: DexmedetomidineDrug: Intranasal cocaine

Normal saline and intranasal cocaine

PLACEBO COMPARATOR

Intranasal cocaine administration (2 mg/kg) then Saline (over 10 minutes I.V. infusion)

Drug: Normal SalineDrug: Intranasal cocaine

Interventions

DexmedetomidineDRUG

Dexmedetomidine (0.3-0.6 mcg/kg) infusion.

Also known as: Precedex
Dexmedetomidine and intranasal cocaine
Normal SalineDRUG

Normal saline infusion (10 cc)

Normal saline and intranasal cocaine
Intranasal cocaineDRUG

Intranasal cocaine (2 mg/kg)

Dexmedetomidine and intranasal cocaineNormal saline and intranasal cocaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult subjects ages of 18-65 years without any history of substance abuse (other than tobacco), including narcotics, abuse of prescription painkillers, cocaine or any other recreational drug

You may not qualify if:

  • Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts or detected by screening echocardiogram performed prior to I.V. infusion of Definity microbubbles
  • Hypersensitivity or prior reactions to Definity microbubbles
  • Pregnant or nursing women
  • Any evidence of cardiopulmonary disease by history or physical examination, including subjects who are taking any cardiovascular medications of any sort
  • History of hypertension or BP at time of consent \> 140/90 mm Hg
  • Any history of substance abuse (other than tobacco), including narcotics, prescription painkillers, cocaine or any other recreational drug (any person that says they have EVER tried these drugs will be excluded from this study)
  • Subjects reporting alcohol intake of more than 2 drinks/day
  • Severe psychiatric illness (e.g., schizophrenia, suicidal depression) in addition to drug dependence, which may signify a high risk of addiction
  • Diabetes mellitus or any other systemic illness
  • Individuals with a history of pseudocholinesterase deficiency
  • Hypersensitivity to dexmedetomidine or lorazepam
  • The presence of alcohol by breathalyzer
  • Subjects who have poor echocardiography images will be screen failed.
  • Persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps (MRI only).
  • Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged (MRI only).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

Related Publications (6)

  • 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.

    PMID: 23283356BACKGROUND

  • 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.

    PMID: 17692748BACKGROUND

  • Tuncel M, Wang Z, Arbique D, Fadel PJ, Victor RG, Vongpatanasin W. Mechanism of the blood pressure--raising effect of cocaine in humans. Circulation. 2002 Mar 5;105(9):1054-9. doi: 10.1161/hc0902.104714.

    PMID: 11877354BACKGROUND

  • Crandall CG, Vongpatanasin W, Victor RG. Mechanism of cocaine-induced hyperthermia in humans. Ann Intern Med. 2002 Jun 4;136(11):785-91. doi: 10.7326/0003-4819-136-11-200206040-00006.

    PMID: 12044126BACKGROUND

  • 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.

    PMID: 10430763BACKGROUND

  • Jacobsen TN, Grayburn PA, Snyder RW 2nd, Hansen J, Chavoshan B, Landau C, Lange RA, Hillis LD, Victor RG. Effects of intranasal cocaine on sympathetic nerve discharge in humans. J Clin Invest. 1997 Feb 15;99(4):628-34. doi: 10.1172/JCI119205.

    PMID: 9045864BACKGROUND

MeSH Terms

Conditions

Chest PainAcute Coronary Syndrome

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ronald G Victor, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 22, 2013

Study Start

February 1, 2013

Primary Completion

January 15, 2014

Study Completion

January 15, 2014

Last Updated

January 14, 2020

Record last verified: 2018-04

Locations

US(1)