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Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate — Ganaxolone  

Smoking Cessation Clinical Trial

Official title:
Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

Clinical Trial Summary

The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.

Clinical Trial Description

The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the neurosteroid analog ganaxolone. The trial will be seeking preliminary indications of efficacy and tolerability in the smoking population and allow us to estimate effect sizes for future controlled trials. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01857531
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 2
Start date June 2013
Completion date February 2014
View Details
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