Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

This study has been terminated.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) VA Boston Healthcare System
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000310

Purpose

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.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Risperidone	Phase II

Drug Information available for: Risperidone Dopamine Dopamine hydrochloride 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Serotonin/Dopamine Antagonism of Cocaine Effect

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Urine toxicology for cocaine
Analog mood scales
POMS
EPS sx

Estimated Enrollment:	0
Study Start Date:	January 1996

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cocaine abuse or dependence

Exclusion Criteria:

Dependence on other drugs. Major psychiatric illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000310

Locations

United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 2906

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

VA Boston Healthcare System

Investigators

Principal Investigator:

Lawrence Price, M.D.

Brown University

More Information

Study ID Numbers:	NIDA-09330-2, R01-09330-2
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000310
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders
Risperidone

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009