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NIDA-CTO-0002

Division

DTMC

HEAL Study

Investigator(s)

Robert J. Malcolm, M.D.

C. Lindsay DeVane, Pharm.D.

Title

Safety Evaluation Of Cocaine Treatment Medication, Modafinil: Interactions With Intravenous Cocaine

Short Description

A study to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Release Date

Aug 01, 2016

Description

The primary objectives of this study are to determine:
1. The safety/tolerability of modafinil as a cocaine treatment medication in cocaine dependent subjects.
2. If administration of intravenous cocaine to subjects (who have demonstrated ability to tolerate the intravenous (i.v.) cocaine administration) maintained on modafinil results in any adverse effects.
3. To determine if there is a pharmacokinetic interaction between cocaine and modafinil.
The secondary objective is to determine: The ability of modafinil to modify the cocaine-related “high” as well as dysphoric reactions to cocaine withdrawal.

Keywords

Assessments

Addiction Severity Index Lite

Blood Cocaine Level

Blood Study Agent Level

Brief Psychiatric Rating Scale

ECG Monitoring

Structured Clinical Interview for DSM Disorders