Back to resultsAssessment of Potential Interactions Between Methamphetamine and Selegiline - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Selegiline
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Volunteers who meet DSM-4 criteria for methamphetamine abuse or dependence; non-treatment seeking individuals Be able to verbalize understanding of consent form; provide written informed consent Exclusion Criteria: Please contact site for more information
Sites / Locations
- UCLA Integrated Substance Abuse Program
Outcomes
Primary Outcome Measures
safety of selegiline
pharmacokinetic assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00033072
First Posted
April 5, 2002
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00033072
Brief Title
Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1
Official Title
Assessment of Potential Interactions Between Intravenous Methamphetamine and Oral Selegiline
Study Type
Interventional
2. Study Status
Record Verification Date
November 2003
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (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 potential interactions between intravenous methamphetamine and oral selegiline.
Detailed Description
To determine the safety of the selegiline concurrent with d-methamphetamine challenges of 15mg & 30mg i.v. with the focus being on cardiovascular responses (HR,BP) to the i.v. methamphetamine challenges. This is a randomized, single-blind, placebo-controlled, two-arm study design to evaluate the safety of selegiline treatment, compared to placebo treatment, concurrent with i.v. methamphetamine challenges.
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
Masking
Single
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Selegiline
Primary Outcome Measure Information:
Title
safety of selegiline
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:
Volunteers who meet DSM-4 criteria for methamphetamine abuse or dependence; non-treatment seeking individuals
Be able to verbalize understanding of consent form; provide written informed consent
Exclusion Criteria:
Please contact 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
12. IPD Sharing Statement
Learn more about this trial
Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1
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