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Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Sponsor: Axsome Therapeutics, Inc.
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.
Official title: A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
705
Start Date
2026-08-27
Completion Date
2027-12
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily for 12 weeks.
Bupropion
Bupropion tablets, taken twice daily for 12 weeks.
Placebo
Placebo tablets, taken twice daily for 12 weeks.
Locations (16)
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Lemon Grove, California, United States
Clinical Research Site
Pomona, California, United States
Clinical Research Site
DeLand, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Stockbridge, Georgia, United States
Clinical Research Site
Skokie, Illinois, United States
Clinical Research Site
Evansville, Indiana, United States
Clinical Research Site
Kansas City, Missouri, United States
Clinical Research Site
Brooklyn, New York, United States
Clinical Research Site
Knoxville, Tennessee, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Fort Worth, Texas, United States
Clinical Research Site
Newport News, Virginia, United States