- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00051896
Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1
January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.
Study Overview
Detailed Description
This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.
Study Type
Interventional
Enrollment
24
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
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Maryland
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Bethesda, Maryland, United States, 20814 4799
- Uniformed Services University of Health Science
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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:
- Must understand study procedures and provide written informed consent
- For additional inclusion criteria information, please contact study site for more information.
Exclusion Criteria:
- Please contact study 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
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetic parameter comparison
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louis Cantilena, M.D., Uniformed Services University of Health Science
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
August 1, 2002
Study Registration Dates
First Submitted
January 17, 2003
First Submitted That Met QC Criteria
January 17, 2003
First Posted (Estimate)
January 20, 2003
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
March 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Vanoxerine
Other Study ID Numbers
- NIDA-CPU-0002-1
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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