NCT00100100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

July 1, 2008

First QC Date

December 22, 2004

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • Cocaine abstinence

Interventions

ModafinilDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Please contact the study site for more information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Boston University Medical Center

Boston, Massachusetts, 02215, United States

Location

New York VA Medical Center

New York, New York, 10010, United States

Location

Cincinnati Addiction Research Center

Cincinnati, Ohio, 45220 2272, United States

Location

Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213 2593, United States

Location

RHD Professional Plaza 4

Dallas, Texas, 75234, United States

Location

UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Domenic Ciraulo, M.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

October 1, 2004

Study Completion

December 1, 2006

Last Updated

January 12, 2017

Record last verified: 2008-07

Locations

US(6)