Back to resultsAssessment of Potential Interactions Between GBR 12909 and Cocaine - 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 focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Must be within 20% ideal body weight and must weigh at least 45 kg. Must understand the study procedures and provide written informed consent. Must meet DSM-4 criteria and are non-treatment seeking at time of study. Exclusion Criteria: Please contact study site for more information
Sites / Locations
- U of Texas Medical Branch Galveston
Outcomes
Primary Outcome Measures
Heart rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00100113
First Posted
December 22, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00100113
Brief Title
Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1
Official Title
Study of Interactions Between GBR 12909 and Cocaine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 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 potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.
Detailed Description
This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Primary Outcome Measure Information:
Title
Heart rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be within 20% ideal body weight and must weigh at least 45 kg.
Must understand the study procedures and provide written informed consent.
Must meet DSM-4 criteria and are non-treatment seeking at time of study.
Exclusion Criteria:
Please contact study site for more information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Cunningham, Ph.D.
Organizational Affiliation
University of Texas Medical Branch - Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of Texas Medical Branch Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555 1031
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1
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