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NCT00000310 Clinical Trial

Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

Cocaine-Related Disorders Clinical Trial

Official title:
Serotonin/Dopamine Antagonism of Cocaine Effect

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00000310
Other study ID # NIDA-09330-2
Secondary ID R01-09330-2
Status Terminated
Phase Phase 2
First received September 20, 1999
Last updated January 13, 2017
Start date January 1996
Est. completion date March 1996

Study information
Verified date January 1996
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date March 1996
Est. primary completion date March 1996
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

Cocaine abuse or dependence

Exclusion Criteria:

Dependence on other drugs. Major psychiatric illness

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Risperidone

Locations
Country Name City State
United States Brown University School of Medicine Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine toxicology for cocaine
Primary Analog mood scales
Primary POMS
Primary EPS sx
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