Ondansetron for the Treatment of Methamphetamine Dependence - 1

This study has been completed.

First Received: June 18, 2002 Last Updated: July 21, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Texas
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00040053

Purpose

The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Ondansetron hydrochloride Ondansetron Amphetamine Methamphetamine

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040053

Locations

United States, California
Matrix Institute on Addictions
Costa Mesa, California, United States, 92627
South Bay Treatment Center
Chula Vista, California, United States, 91911
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

Investigators

Principal Investigator:

Thomas Newton, M.D.

National Institute on Drug Abuse (NIDA)

More Information

No publications provided

Study ID Numbers:	NIDA-CTO-0011-1
Study First Received:	June 18, 2002
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00040053 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Antiemetics
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Antipruritics

Ondansetron
Dermatologic Agents
Tranquilizing Agents
Sympathomimetics
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Antipsychotic Agents
Pharmacologic Actions
Methamphetamine
Serotonin Agents
Autonomic Agents
Amphetamine-Related Disorders
Anti-Anxiety Agents
Dopamine Agents

ClinicalTrials.gov processed this record on February 08, 2010