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Interactions Between Cocaine and Ethanol and Disulfiram - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00094289
Recruitment Status : Unknown
Verified July 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2004
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE October 15, 2004
First Posted Date  ICMJE October 15, 2004
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Safety assessments
  • Psychological effects
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00094289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interactions Between Cocaine and Ethanol and Disulfiram - 1
Official Title  ICMJE Interactions Between IV Cocaine and Ethanol and Oral Disulfiram
Brief Summary The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.
Detailed Description This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol-Related Disorders
  • Cocaine-Related Disorders
Intervention  ICMJE Drug: Disulfiram
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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 Unknown status
Enrollment  ICMJE
 (submitted: July 26, 2005)
16
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
18
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
  • Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.

Exclusion Criteria:

  • Please contact site for more information.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00094289
Other Study ID Numbers  ICMJE NIDA-MDS-0003-1
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 National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Roache, Ph.D. University of Texas Health Sci Cntr, San Antonio
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date July 2005

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