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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00033046
First received: April 5, 2002
Last updated: February 8, 2007
Last verified: May 2004

April 5, 2002
February 8, 2007
June 2001
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  • pharmacokinetic parmaters at steady state
  • BP, HR
Same as current
Complete list of historical versions of study NCT00033046 on ClinicalTrials.gov Archive Site
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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.
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cocaine-Related Disorders
  • Drug Administration Schedule
  • Infusions, Intravenous
Drug: Modafinil
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
12
April 2002
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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

Both
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033046
NIDA-CTO-0002-1
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National Institute on Drug Abuse (NIDA)
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Principal Investigator: Robert Malcolm, M.D. Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP