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NCT00040053 Clinical Trial

Ondansetron for the Treatment of Methamphetamine Dependence - 1

Amphetamine-Related Disorders Clinical Trial

Official title:
Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00040053
Other study ID # NIDA-CTO-0011-1
Secondary ID
Status Completed
Phase Phase 2
First received June 18, 2002
Last updated January 11, 2017
Start date June 2002
Est. completion date February 2004

Study information
Verified date July 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ondansetron

Locations
Country Name City State
United States South Bay Treatment Center Chula Vista California
United States Matrix Institute on Addictions Costa Mesa California
United States Powell Chemical Dependency Center Des Moines Iowa
United States John A. Burns School of Medicine Honolulu Hawaii
United States University of Texas Health Science Center Houston Texas
United States University of Missouri - Kansas City Kansas City Missouri

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) University of Texas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinicial improvement
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