- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033085
Ondansetron for the Treatment of Cocaine Dependence - 1
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence
The purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.
Study Type
Interventional
Enrollment
60
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
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Texas
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San Antonio, Texas, United States, 78284 7828
- University of Texas Hlth Sci Ctr San Ant
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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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking Treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control
Exclusion Criteria:
Additional criteria available during screening at the site.
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cocaine use
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John Roache, Ph.D., University of Texas
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
May 1, 2001
Study Completion
December 1, 2002
Study Registration Dates
First Submitted
April 5, 2002
First Submitted That Met QC Criteria
April 5, 2002
First Posted (Estimate)
April 8, 2002
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
July 1, 2008
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
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- NIDA-CTO-0005-1
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
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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
-
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
-
Tonix Pharmaceuticals, Inc.National Institute on Drug Abuse (NIDA); PremierNot yet recruitingCocaine Use | Cocaine Abuse | Cocaine Adverse Reaction | Cocaine Intoxication | Cocaine Toxicity
-
Temple UniversityNational Institute on Drug Abuse (NIDA); University of PennsylvaniaCompletedCocaine-Related Disorders | 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
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingCocaine Dependence | Cocaine Use | Cocaine Abuse | NeurotropismItaly
-
University of VirginiaRecruitingCocaine Use Disorder | Cocaine Dependence | Ultrasound | Cocaine AbuseUnited States
-
University Hospital Center of MartiniqueUnknown
Clinical Trials on Ondansetron
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Merck Sharp & Dohme LLCCompletedChemotherapy-Induced Nausea and Vomiting
-
Seoul National University Bundang HospitalRecruiting
-
Tanta UniversityRecruitingCaesarean Section | Postoperative Nausea and Vomiting | Ondansetron LozengeEgypt
-
Halozyme TherapeuticsCompleted
-
Aquestive TherapeuticsCompleted
-
Washington University School of MedicineCompleted
-
General Hospital of Ningxia Medical UniversityCompleted
-
Merck Sharp & Dohme LLCCompletedChemotherapy-Induced Nausea and Vomiting