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

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

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

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.

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