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Completed

NCT Number: NCT00033085

Ondansetron for the Treatment of Cocaine Dependence - 1

The purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.

Completed

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Drug Administration Schedule Mental Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Hlth Sci Ctr San Ant

San Antonio, Texas, 78284 7828, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

Primary outcomes

  1. Cocaine use

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • University of Texas

Registry information

Official study title

Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence

Important dates

Study start
2001
Study completion
2002
First posted
Apr 8, 2002
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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