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IV Cocaine Abuse: A Laboratory Model - 2

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: NCT00000213
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : August 28, 2015
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Columbia University
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date August 28, 2015
Study Start Date  ICMJE April 1990
Actual Primary Completion Date April 1991   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Direct cocaine effects
  • Interaction of cocaine/fluox. on cardio measures
  • Interaction of cocaine/fluox. on coc's subjective
  • Effects of fluoxetine on cocaine craving
  • Drug use during outpatient fluoxetine maintenance
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 IV Cocaine Abuse: A Laboratory Model - 2
Official Title  ICMJE IV Cocaine Abuse: A Laboratory Model
Brief Summary The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Fluoxetine
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 Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		 0
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1991
Actual Primary Completion Date April 1991   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Please contact site for information.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT00000213
Other Study ID Numbers  ICMJE NIDA-06234-2
R01DA006234 ( U.S. NIH Grant/Contract )
R01-06234-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party New York State Psychiatric Institute
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE New York State Psychiatric Institute
Original Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Columbia University
Investigators  ICMJE
Principal Investigator: Richard Foltin, Ph.D. Columbia University
PRS Account New York State Psychiatric Institute
Verification Date December 2012

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