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

Condition(s) targeted: Cocaine-Related Disorders; Drug Administration Schedule; Infusions, Intravenous

Intervention: Modafinil (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Robert Malcolm, M.D., Principal Investigator, Affiliation: Medical University of South Carolina

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

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

Study design: Treatment, Double-Blind, Dose Comparison, Crossover Assignment

Primary outcome:

pharmacokinetic parmaters at steady state

BP, HR

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Medical University of South Carolina, Charleston, South Carolina 29425 742, United States

Starting date: June 2001
Ending date: April 2002
Last updated: February 8, 2007