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

"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."

"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)."