Back to resultsAssessment of Interactions Between Methamphetamine and Aripiprazole - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders
Eligibility Criteria
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.
Sites / Locations
- UCLA Integrated Substance Abuse Program
- New York University, School of Medicine
Outcomes
Primary Outcome Measures
Adverse effect measures
pharmacokinetic assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00089440
First Posted
August 5, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00089440
Brief Title
Assessment of Interactions Between Methamphetamine and Aripiprazole - 1
Official Title
Assessment of Interactions Between IV Methamphetamine and Aripiprazole
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
17 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Adverse effect measures
Title
pharmacokinetic assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Newton, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
New York University, School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Interactions Between Methamphetamine and Aripiprazole - 1
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