Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ondansetron for the Treatment of Methamphetamine Dependence - 1

This study has been completed.
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: June 18, 2002
Last updated: July 21, 2008
Last verified: July 2008
The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

Condition Intervention Phase
Amphetamine-Related Disorders
Drug: Ondansetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Clinicial improvement

Estimated Enrollment: 154
Study Start Date: June 2002
Study Completion Date: February 2004
Detailed Description:
This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00040053

United States, California
South Bay Treatment Center
Chula Vista, California, United States, 91911
Matrix Institute on Addictions
Costa Mesa, California, United States, 92627
United States, Hawaii
John A. Burns School of Medicine
Honolulu, Hawaii, United States, 96813
United States, Iowa
Powell Chemical Dependency Center
Des Moines, Iowa, United States, 50316
United States, Missouri
University of Missouri - Kansas City
Kansas City, Missouri, United States, 64108
United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77225
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Texas
Principal Investigator: Thomas Newton, M.D. National Institute on Drug Abuse (NIDA)
  More Information Identifier: NCT00040053     History of Changes
Other Study ID Numbers: NIDA-CTO-0011-1 
Study First Received: June 18, 2002
Last Updated: July 21, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents processed this record on October 28, 2016