Back to resultsAssessment of Potential Interactions Between Cocaine and RPR 102681 - 1
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cocaine-Related Disorders
Sponsored by
About this trial
This is an interventional diagnostic trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Includes but is not limited to: Non-treatment seekers DSM-IV criteria for cocaine abuse or dependence Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements Exclusion Criteria: Please contact site for more information.
Sites / Locations
- Uniformed Services University of Health Science
Outcomes
Primary Outcome Measures
Hemodynamic response to cocaine and subjective response to cocaine
Secondary Outcome Measures
Full Information
NCT ID
NCT00067535
First Posted
August 21, 2003
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00067535
Brief Title
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1
Official Title
Potential Interactions Between IV Cocaine and RPR 102681
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
June 2005 (Actual)
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 iv Cocaine and RPR 102681
Detailed Description
Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential Interactions Between Intravenous Cocaine and RPR 102681
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
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cocaine-Related Disorders
Primary Outcome Measure Information:
Title
Hemodynamic response to cocaine and subjective response to cocaine
Time Frame
3x / 30 days
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:
Includes but is not limited to:
Non-treatment seekers
DSM-IV criteria for cocaine abuse or dependence
Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements
Exclusion Criteria:
Please contact 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 Potential Interactions Between Cocaine and RPR 102681 - 1
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