Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1
This trial is active, not recruiting.
|Conditions||cocaine-related disorders, drug administration schedule, infusions, intravenous|
|Sponsor||National Institute on Drug Abuse (NIDA)|
|Start date||June 2001|
|End date||April 2002|
|Trial size||12 participants|
|Trial identifier||NCT00033046, NCT00024752, NIDA-CTO-0002-1|
The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
|Intervention model||crossover assignment|
pharmacokinetic parmaters at steady state
Male or female participants from 18 years up to 45 years old.
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
|Official title||Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine|
|Principal investigator||Robert Malcolm, M.D.|
|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.|
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