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NIDA-CPU-0005

Division

DTMC

HEAL Study

Investigator(s)

Louis Cantilena, Jr., M.D, Ph.D.

Title

Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers.

Short Description

To assess the safety, tolerance, and pharmacokinetics of multiple dosages of 75mg oral GBR 12909 in cocaine experienced volunteers. Effects on WBC and ANC will be the primary hematology outcome measure.

Release Date

May 23, 2017

Description

This is a human laboratory study that will assess the clinical pharmacology, safety and tolerance of 75mg oral doses of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride, in cocaine experienced volunteers. Particular interest is being given to the hematological safety data.

Keywords

Assessments

Addiction Research Center Inventory

Blood Study Agent Level

Brief Substance Craving Scale

Change in Sexual Function Questionnaire

McLean Hospital Event Overt Aggression Checklist

Systematic Assessment for Treatment Emergent Effects