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Assessment of Potential Interactions Between Cocaine and Tolcapone - 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: NCT00033059
Recruitment Status : Unknown
Verified August 2003 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2002
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE April 5, 2002
First Posted Date  ICMJE April 8, 2002
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE July 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Safety
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 Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
Official Title  ICMJE Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone
Brief Summary The purpose of this study is to assess the potential interactions between intravenous (IV) cocaine and tolcapone.
Detailed Description Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Tolcapone
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: June 23, 2005)
16
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence

Exclusion Criteria:

Additional criteria available during screening at the site

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 NCT00033059
Other Study ID Numbers  ICMJE NIDA-CTO-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: Thomas Newton, M.D. National Institute on Drug Abuse (NIDA)
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date August 2003

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