NCT00033046

Brief Summary

The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2001

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
Last Updated

January 11, 2017

Status Verified

May 1, 2004

First QC Date

April 5, 2002

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related DisordersDrug Administration ScheduleInfusions, Intravenous

Outcome Measures

Primary Outcomes (2)

  • pharmacokinetic parmaters at steady state

  • BP, HR

Interventions

ModafinilDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

You may not qualify if:

  • Additional criteria available during screening at the site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425 742, 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

  • Robert Malcolm, M.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

June 1, 2001

Study Completion

April 1, 2002

Last Updated

January 11, 2017

Record last verified: 2004-05

Locations

US(1)