Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 16, 2005

Start Date ^ICMJE

January 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Urine toxicology for cocaine
Analog mood scales
POMS
EPS sx

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000310 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

Official Title ^ICMJE

Serotonin/Dopamine Antagonism of Cocaine Effect

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Risperidone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cocaine abuse or dependence

Exclusion Criteria:

Dependence on other drugs. Major psychiatric illness

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000310

Responsible Party

Study ID Numbers ^ICMJE

NIDA-09330-2, R01-09330-2

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

VA Boston Healthcare System

Investigators ^ICMJE

Principal Investigator:

Lawrence Price, M.D.

Brown University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 1996

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP