- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033072
Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1
January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
Assessment of Potential Interactions Between Intravenous Methamphetamine and Oral Selegiline
The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral selegiline.
Study Overview
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.
Study Type
Interventional
Enrollment
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- UCLA Integrated Substance Abuse Program
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
pharmacokinetic assessment
|
safety of selegiline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Newton, M.D., University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion
October 1, 2002
Study Registration Dates
First Submitted
April 5, 2002
First Submitted That Met QC Criteria
April 5, 2002
First Posted (Estimate)
April 8, 2002
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
November 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Amphetamine-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Neuroprotective Agents
- Protective Agents
- Psychotropic Drugs
- Antidepressive Agents
- Monoamine Oxidase Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Selegiline
Other Study ID Numbers
- NIDA-CTO-0004-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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