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

Cocaine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00033046
• Other study ID #: NIDA-CTO-0002-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 5, 2002
• Last updated: January 10, 2017
• Start date: June 2001
• Est. completion date: April 2002

Study information

• Verified date: May 2004
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00024752

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Drug Administration Schedule
• Infusions, Intravenous

Intervention

Drug:
• Modafinil

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic parmaters at steady state
Primary	BP, HR