Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Start Date
8/27/2026
Completion Date
12/1/2027
Summary
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.
Detailed Description
Eligible subjects will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 12 weeks, followed by an 18-week follow-up period.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
AXS-05 (dextromethorphan-bupropion)
Bupropion
Placebo
Conditions
Locations
Clinical Research Site
Little Rock, Arkansas 72211
United States
Clinical Research Site
Lemon Grove, California 91945
United States
Clinical Research Site
Long Beach, California 90806
United States
Clinical Research Site
Pomona, California 91767
United States
Clinical Research Site
DeLand, Florida 32720
United States
Clinical Research Site
Jacksonville, Florida 32256
United States
Clinical Research Site
Orlando, Florida 32801
United States
Clinical Research Site
Tampa, Florida 33614
United States
Clinical Research Site
Columbus, Georgia 31901
United States
Clinical Research Site
Stockbridge, Georgia 30281
United States
Clinical Research Site
Skokie, Illinois 60077
United States
Clinical Research Site
Evansville, Indiana 47714
United States
Clinical Research Site
Kansas City, Missouri 64114
United States
Clinical Research Site
Brooklyn, New York 11229
United States
Clinical Research Site
Brooklyn, New York 11235
United States
Clinical Research Site
Rochester, New York 14609
United States
Clinical Research Site
Duncansville, Pennsylvania 16635
United States
Clinical Research Site
North Charleston, South Carolina 29405
United States
Clinical Research Site
Knoxville, Tennessee 37909
United States
Clinical Research Site
Memphis, Tennessee 38119
United States
Clinical Research Site
Nashville, Tennessee 37203
United States
Clinical Research Site
Austin, Texas 78705
United States
Clinical Research Site
Dallas, Texas 75251
United States
Clinical Research Site
Fort Worth, Texas 76135
United States
Clinical Research Site
Huston, Texas 77061
United States
Clinical Research Site
Newport News, Virginia 23606
United States