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Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 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: NCT00000309
Recruitment Status : Terminated (Unable to recruit adequate number of subjects)
First Posted : September 21, 1999
Last Update Posted : July 24, 2015
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
VA Boston Healthcare System
Information provided by (Responsible Party):
Lawrence H. Price, Butler Hospital

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date July 24, 2015
Study Start Date  ICMJE August 1994
Actual Primary Completion Date January 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Analog mood scales
  • POMS
  • EPS sx
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 Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1
Official Title  ICMJE Serotonin/Dopamine Antagonism of Cocaine Effect
Brief Summary The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Risperidone
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 Terminated
Enrollment  ICMJE
 (submitted: June 23, 2005)
0
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2000
Actual Primary Completion Date January 2000   (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 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 NCT00000309
Other Study ID Numbers  ICMJE NIDA-09330-1
R01DA009330 ( U.S. NIH Grant/Contract )
R01-09330-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lawrence H. Price, Butler Hospital
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Butler Hospital
Original Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • VA Boston Healthcare System
Investigators  ICMJE
Principal Investigator: Lawrence Price, M.D. Brown University
PRS Account Butler Hospital
Verification Date July 2015

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