Risperidone for the Treatment of Cocaine Dependence - 7 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

July 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Risperidone for the Treatment of Cocaine Dependence - 7

Official Title ^ICMJE

Risperidone for the Treatment of Cocaine Dependence

Brief Summary

The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical side-effects.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control, Parallel Assignment

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

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Gender

Both

Ages

21 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

NCT00000342

Responsible Party

Study ID Numbers ^ICMJE

NIDA-3-0010-7, Y01-3-0010-7

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

June 1997

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