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NCT00100100 Clinical Trial

Modafinil for the Treatment of Cocaine Dependence - 1

Cocaine-Related Disorders Clinical Trial

Official title:
Modafinil for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00100100
Other study ID # NIDA-MDS-0004-1
Secondary ID
Status Completed
Phase Phase 2
First received December 22, 2004
Last updated January 11, 2017
Start date October 2004
Est. completion date December 2006

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Description:

This is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID.

- Must be seeking treatment for cocaine dependence.

- Must be able to understand and provide written informed consent.

Exclusion Criteria:

- Please contact the study site for more information.

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Modafinil

Locations
Country Name City State
United States Boston University Medical Center Boston Massachusetts
United States Cincinnati Addiction Research Center Cincinnati Ohio
United States RHD Professional Plaza 4 Dallas Texas
United States New York VA Medical Center New York New York
United States Western Psychiatric Institute & Clinic Pittsburgh Pennsylvania
United States UTHSCSA San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cocaine abstinence
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