Modafinil for the Treatment of Cocaine Dependence - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00100100
• Collaborator: (none)
• Enrollment: 210
• Locations: 6
• Duration (Months): 26
• Patients Per Site: 35
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders	Drug: Modafinil	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Primary Purpose: Diagnostic
• Official Title: Modafinil for the Treatment of Cocaine Dependence
• Study Start Date: Oct 1, 2004
• Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. Cocaine abstinence []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University Medical Center	Boston	Massachusetts	United States	02215
2	New York VA Medical Center	New York	New York	United States	10010
3	Cincinnati Addiction Research Center	Cincinnati	Ohio	United States	45220 2272
4	Western Psychiatric Institute & Clinic	Pittsburgh	Pennsylvania	United States	15213 2593
5	RHD Professional Plaza 4	Dallas	Texas	United States	75234
6	UTHSCSA	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Domenic Ciraulo, M.D., Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00100100
• Other Study ID Numbers: NIDA-MDS-0004-1
• First Posted: Dec 23, 2004
• Last Update Posted: Jan 12, 2017
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: cocaine dependence
• Additional relevant MeSH terms: Cocaine-Related Disorders; Modafinil

Study Results

No Results Posted as of Jan 12, 2017