Back to resultsSerotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2
Primary Purpose
Cocaine-Related Disorders
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Cocaine abuse or dependence Exclusion Criteria: Dependence on other drugs. Major psychiatric illness
Sites / Locations
- Brown University School of Medicine
Outcomes
Primary Outcome Measures
Urine toxicology for cocaine
Analog mood scales
POMS
EPS sx
Secondary Outcome Measures
Full Information
NCT ID
NCT00000310
First Posted
September 20, 1999
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
VA Boston Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00000310
Brief Title
Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2
Official Title
Serotonin/Dopamine Antagonism of Cocaine Effect
Study Type
Interventional
2. Study Status
Record Verification Date
January 1996
Overall Recruitment Status
Terminated
Study Start Date
January 1996 (undefined)
Primary Completion Date
March 1996 (Actual)
Study Completion Date
March 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
VA Boston Healthcare System
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.
Detailed Description
Risperidone in low doses is compared with placebo in a 6-week randomized trial. Subjects also receive supportive counseling. Outcome measure include rating of behavior, mood, drug abuse, global function, and urine toxicology.
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 2
Masking
Double
Allocation
Randomized
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
Urine toxicology for cocaine
Title
Analog mood scales
Title
POMS
Title
EPS sx
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cocaine abuse or dependence
Exclusion Criteria:
Dependence on other drugs. Major psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Price, M.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
2906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2
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