Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

February 8, 2007

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

pharmacokinetic parmaters at steady state
BP, HR

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00033046 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

Official Title ^ICMJE

Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

Brief Summary

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

Detailed Description

Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Dose Comparison, Crossover Assignment

Condition ^ICMJE

Cocaine-Related Disorders
Drug Administration Schedule
Infusions, Intravenous

Intervention ^ICMJE

Drug: Modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

April 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

Additional criteria available during screening at the site

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00033046

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CTO-0002-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Robert Malcolm, M.D.

Medical University of South Carolina

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

May 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP