Back to resultsEvaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
Primary Purpose
Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements. Exclusion Criteria: Additional criteria available during screening at the site
Sites / Locations
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
pharmacokinetic parmaters at steady state
BP, HR
Secondary Outcome Measures
Full Information
NCT ID
NCT00033046
First Posted
April 5, 2002
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00033046
Brief Title
Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
Official Title
Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Unknown status
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 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 evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
Detailed Description
Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Modafinil
Primary Outcome Measure Information:
Title
pharmacokinetic parmaters at steady state
Title
BP, HR
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:
Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.
Exclusion Criteria:
Additional criteria available during screening at the site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Malcolm, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425 742
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
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