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Assessment of Interactions Between Methamphetamine and Aripiprazole - 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: NCT00089440
Recruitment Status : Unknown
Verified July 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2004
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE August 5, 2004
First Posted Date  ICMJE August 6, 2004
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Adverse effect measures
  • pharmacokinetic assessment
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 Interactions Between Methamphetamine and Aripiprazole - 1
Official Title  ICMJE Assessment of Interactions Between IV Methamphetamine and Aripiprazole
Brief Summary The purpose of this study is to assess the interactions between intravenous methamphetamine and aripiprazole.
Detailed Description This is a double-blind, placebo-controlled human laboratory clinical pharmacology study to assess potential interactions between intravenous d-methamphetamine infusion and treatment with oral aripiprazole.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Amphetamine-Related Disorders
Intervention  ICMJE Drug: Aripiprazole
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)
17
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
16
Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must meet DSM-4 criteria for methamphetamine abuse or dependence and are non-treatment seeking.
  • Ability to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.

Exclusion Criteria:

  • Please contact the site for more 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 NCT00089440
Other Study ID Numbers  ICMJE NIDA-MDS-0002-1
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. University of California, Los Angeles
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