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

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Unknown status
• CT.gov ID: NCT00033046
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders; Drug Administration Schedule; Infusions, Intravenous	Drug: Modafinil	Phase 1

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 Design

• Study Type: Interventional
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine
• Study Start Date: Jun 1, 2001
• Study Completion Date: Apr 1, 2002

Outcome Measures

Primary Outcome Measures

1. pharmacokinetic parmaters at steady state []

2. BP, HR []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425 742

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Robert Malcolm, M.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00033046
• Other Study ID Numbers: NIDA-CTO-0002-1; NCT00024752
• First Posted: Apr 8, 2002
• Last Update Posted: Jan 11, 2017
• Last Verified: May 1, 2004

• Additional relevant MeSH terms: Cocaine-Related Disorders; Modafinil

Study Results

No Results Posted as of Jan 11, 2017