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Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine

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ClinicalTrials.gov Identifier: NCT00338546
Recruitment Status : Withdrawn
First Posted : June 20, 2006
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 16, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
  • Blood pressure
  • Heart rate
  • Skin sympathetic nerve activity
  • Skin blood flow
  • Coronary blood flow
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
Sedation status
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Improve Scientific Understanding of the Cardiovascular Actions of Cocaine
Official Title  ICMJE Cocaine and Sympathetic Nerve Activity in Humans
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cocaine Induced Sympathoexciation and Vasoconstriction
Intervention  ICMJE
  • Drug: Cocaine hydrochloride
  • Drug: Dexmedetomidine
  • Procedure: Microneurography
  • Procedure: Laser doppler velocimetry
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 15, 2019)
0
Original Enrollment  ICMJE
 (submitted: June 16, 2006)
440
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00338546
Other Study ID Numbers  ICMJE 2RO1DA01006409
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Ronald G Victor, MD Univ of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP