Back to resultsAssessment of the Potential Interactions Between Cocaine and GBR 12909 - 1
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBR 12909
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
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.
Sites / Locations
- Uniformed Services University of Health Science
Outcomes
Primary Outcome Measures
Pharmacokinetic parameter comparison
Secondary Outcome Measures
Full Information
NCT ID
NCT00051896
First Posted
January 17, 2003
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00051896
Brief Title
Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1
Official Title
Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (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 iv cocaine and GBR 12909.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Primary Outcome Measure Information:
Title
Pharmacokinetic parameter comparison
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Cantilena, M.D.
Organizational Affiliation
Uniformed Services University of Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of Health Science
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814 4799
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1
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