Back to resultsAssessment of Potential Interactions Between Cocaine and Tolcapone - 1
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tolcapone
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence Exclusion Criteria: Additional criteria available during screening at the site
Sites / Locations
- UCLA Integrated Substance Abuse Program
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00033059
First Posted
April 5, 2002
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00033059
Brief Title
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
Official Title
Assessment of Potential Interactions Between Intravenous Cocaine and Tolcapone
Study Type
Interventional
2. Study Status
Record Verification Date
August 2003
Overall Recruitment Status
Unknown status
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (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 intravenous (IV) cocaine and tolcapone.
Detailed Description
Double-blind, inpatient study by screening responses to cocaine infusions of 20 and 40 mg i.v. subjects into 1 of 2 treatment groups to assess potential interactions between i.v. cocaine infusion and treatment with tolcapone.
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
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tolcapone
Primary Outcome Measure Information:
Title
Safety
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:
Volunteers dependent on cocaine and are non-treatment seeking; between 18-45 yrs of age; DSM-4 criteria for cocaine abuse or dependence
Exclusion Criteria:
Additional criteria available during screening at the site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Newton, M.D.
Organizational Affiliation
National Institute on Drug Abuse (NIDA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
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