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

Phase 1

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

• Registration Number: NCT00033046
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 Timeline

• Study Start: 2001-06
• Study Completion: 2002-04
• Study First Submitted: 2002-04-05
• Study First Submitted QC: 2002-04-05
• Study First Posted: 2002-04-08
• Status Verified: 2004-05
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
pharmacokinetic parmaters at steady state
BP, HR

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States