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Gepirone vs Placebo in Treatment of Cocaine Dependence - 3

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: NCT00000189
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
James Cornish, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 20, 1999
First Posted Date  ICMJE September 21, 1999
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE January 1990
Actual Primary Completion Date February 1991   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
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 Gepirone vs Placebo in Treatment of Cocaine Dependence - 3
Official Title  ICMJE Gepirone vs Placebo in Treatment of Cocaine Dependence
Brief Summary The purpose of this study is to test antidepressant medication, gepirone, as a pharmacotherapy for cocaine dependent subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Gepirone
Study Arms  ICMJE Not Provided
Publications * Jenkins SW, Warfield NA, Blaine JD, Cornish J, Ling W, Rosen MI, Urschel H 3rd, Wesson D, Ziedonis D. A pilot trial of gepirone vs. placebo in the treatment of cocaine dependency. Psychopharmacol Bull. 1992;28(1):21-6.

*   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
Actual Enrollment  ICMJE
 (submitted: March 1, 2013)		 41
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		 0
Actual Study Completion Date  ICMJE February 1991
Actual Primary Completion Date February 1991   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Please contact site for information.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older 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 NCT00000189
Other Study ID Numbers  ICMJE NIDA-00144-3
3R01DA012268 ( U.S. NIH Grant/Contract )
K20-00144-3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party James Cornish, University of Pennsylvania
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: James Cornish, M.D. University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date May 2015

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