Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
Axsome Therapeutics, Inc.
705 participants
Aug 27, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
AXS-05 tablets, taken twice daily for 12 weeks.
Bupropion tablets, taken twice daily for 12 weeks.
Placebo tablets, taken twice daily for 12 weeks.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07766655