- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000342
Risperidone for the Treatment of Cocaine Dependence - 7
January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)
Risperidone for the Treatment of Cocaine Dependence
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Friends Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1996
Primary Completion (Actual)
August 1, 1997
Study Completion (Actual)
September 1, 1997
Study Registration Dates
First Submitted
September 20, 1999
First Submitted That Met QC Criteria
September 20, 1999
First Posted (Estimate)
September 21, 1999
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
June 1, 1997
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- NIDA-3-0010-7
- Y01-3-0010-7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cocaine-Related Disorders
-
Tonix Pharmaceuticals, Inc.National Institute on Drug Abuse (NIDA); PremierNot yet recruitingCocaine Use | Cocaine Abuse | Cocaine Adverse Reaction | Cocaine Intoxication | Cocaine Toxicity
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Columbia UniversityNot yet recruitingCocaine Use Disorder | Cocaine Dependence | Cocaine Use | Cocaine Use Disorder, Moderate | Cocaine Use Disorder, Severe
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Temple UniversityNational Institute on Drug Abuse (NIDA); University of PennsylvaniaCompletedCocaine-Related Disorders | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingCocaine Dependence | Cocaine Use | Cocaine Abuse | NeurotropismItaly
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
-
Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
Clinical Trials on Risperidone
-
Rovi Pharmaceuticals LaboratoriesCompletedAcute SchizophreniaUnited States, Ukraine
-
Northwestern UniversityOrtho-McNeil Janssen Scientific Affairs, LLCCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Rovi Pharmaceuticals LaboratoriesCompletedSchizophrenia | Schizoaffective DisorderSpain, South Africa, Russian Federation, Croatia
-
Zogenix, Inc.CompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Zogenix, Inc.Completed
-
Janssen-Cilag S.p.A.CompletedSchizophrenia | Schizoaffective Disorder
-
Rovi Pharmaceuticals LaboratoriesRecruiting
-
Xijing HospitalUnknown
-
Hoffmann-La RocheCompleted
-
Janssen Korea, Ltd., KoreaCompleted