Ondansetron for the Treatment of Cocaine Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Drug Administration Schedule; Cocaine-Related Disorders

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00033085

NIDA-CTO-0005-1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind