Home › Quitting Smoking › NCT07766655

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

Who can join

Ages 18 to 65 · All sexes

Inclusion Criteria:

* Male or female, aged 18 to 65 (inclusive)

Exclusion Criteria:

* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

About the study

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.

What is being tested

• AXS-05 (dextromethorphan-bupropion) (drug)
• Bupropion (drug)
• Placebo (drug)

Sponsor: Axsome Therapeutics, Inc. · Participants: 705 · Started: Aug 27, 2026

Contact the study team

• Study Director · Phone: 212-332-5061

Official record on ClinicalTrials.gov — NCT07766655

Locations in the U.S.

Conditions

• Quitting Smoking
• Smoking and Youth

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.