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

National Institutes of Health (NIH)

Status and phase: Unknown; Phase 1

Conditions: Infusions, Intravenous; Drug Administration Schedule; Cocaine-Related Disorders

Treatments: Drug: Modafinil

Study type: Interventional

Funder types: NIH

Identifiers

NCT00033046

NIDA-CTO-0002-1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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