NCT00338546

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

First QC Date

June 16, 2006

Last Update Submit

January 15, 2019

Conditions

Cocaine Induced Sympathoexciation and Vasoconstriction

Keywords

CocaineSympathetic nerve activityBlood pressureCutaneous vasoconstrictionCoronary vasoconstriction

Outcome Measures

Primary Outcomes (5)

  • Blood pressure

  • Heart rate

  • Skin sympathetic nerve activity

  • Skin blood flow

  • Coronary blood flow

Secondary Outcomes (1)

  • Sedation status

Interventions

Cocaine hydrochlorideDRUG
DexmedetomidineDRUG
MicroneurographyPROCEDURE
Laser doppler velocimetryPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Cocaine naive healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (3)

  • 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: 10430763RESULT

  • 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: 23283356DERIVED

  • 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: 17692748DERIVED

MeSH Terms

Interventions

CocaineDexmedetomidineLaser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

TropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingImidazolesAzolesHeterocyclic Compounds, 1-RingDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRheologyInvestigative Techniques

Study Officials

  • Ronald G Victor, MD

    Univ of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)