NCT01857531

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Jed E. Rose · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Ganaxolone	Pre-Quit Period: Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks. Post-Quit Period: Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three.
DRUG	Nicotine Patch	Pre-Quit Period: Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks. Post-Quit Period: Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week).

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2014-02-01
• First posted: 2013-05-20
• Last updated: 2014-09-08
• Results posted: 2014-09-08

Locations

4 sites across 1 country: United States