NIDA-CPU-0002

Division
DTMC
HEAL Study
No
Investigator(s)
Louis Cantilena, Jr., M.D, Ph.D.
Title
Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
Short Description
To assess the safety, tolerance, and pharmacokinetics of multiple escalating dosages of oral GBR 12909 in cocaine experienced volunteers.
Release Date
May 23, 2017
Description

This is a human laboratory study that will assess the clinical pharmacology, safety and tolerance of three escalating oral doses of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride, in cocaine experienced volunteers.

Keywords
cocaine
gbr12909
interaction
phase 1a
stimulant
Assessments
Addiction Research Center Inventory
Blood Study Agent Level
Brief Substance Craving Scale
Change in Sexual Function Questionnaire
ECG Monitoring
McLean Hospital Event Overt Aggression Checklist
Systematic Assessment for Treatment Emergent Effects
Vital Signs Monitoring
Accessibility Notice

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Study Data
CPU-0002 Data
Study Links
ClinicalTrials.gov Link
CPU-0002 in NIH clinical trials registry
Study Documents
Protocol
CPU0002-Protocol.pdf
Dictionary
CPU0002-Dictionary.xlsx
Case Report Form(s)
CPU0002-CRF.pdf
Deidentification Notes
CPU0002-DeidentificationNotes.pdf
Nulled Values
CPU0002-NulledValues.csv
All Documents
CPU0002-AllDocuments.zip