Back to resultsModafinil for the Treatment of Cocaine Dependence - 1
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Sponsored by
About this trial
This is an interventional diagnostic trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID. Must be seeking treatment for cocaine dependence. Must be able to understand and provide written informed consent. Exclusion Criteria: Please contact the study site for more information.
Sites / Locations
- Boston University Medical Center
- New York VA Medical Center
- Cincinnati Addiction Research Center
- Western Psychiatric Institute & Clinic
- RHD Professional Plaza 4
- UTHSCSA
Outcomes
Primary Outcome Measures
Cocaine abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00100100
First Posted
December 22, 2004
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00100100
Brief Title
Modafinil for the Treatment of Cocaine Dependence - 1
Official Title
Modafinil for the Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (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 the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.
Detailed Description
This is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.
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 2
Enrollment
210 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Modafinil
Primary Outcome Measure Information:
Title
Cocaine abstinence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID.
Must be seeking treatment for cocaine dependence.
Must be able to understand and provide written informed consent.
Exclusion Criteria:
Please contact the study site for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenic Ciraulo, M.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
New York VA Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Cincinnati Addiction Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220 2272
Country
United States
Facility Name
Western Psychiatric Institute & Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213 2593
Country
United States
Facility Name
RHD Professional Plaza 4
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Modafinil for the Treatment of Cocaine Dependence - 1
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