Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

NCT07766655 · tracked via the Priya Life Science USA tracker

Sponsor

Axsome Therapeutics, Inc.

Phase

Phase 3

Started

2026-08-27

Last updated

2026-09-08

Condition(s) studied

Smoking Cessation

Investigational drug(s) / intervention(s)

AXS-05 (dextromethorphan-bupropion)BupropionPlacebo

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

4-Week Continuous Smoking Abstinence Rate — Weeks 9 to 12

Trial sites (16)

Facility	City	Region	Status
Clinical Research Site	Little Rock	Arkansas	Recruiting
Clinical Research Site	Lemon Grove	California	Recruiting
Clinical Research Site	Pomona	California	Recruiting
Clinical Research Site	DeLand	Florida	Recruiting
Clinical Research Site	Jacksonville	Florida	Recruiting
Clinical Research Site	Orlando	Florida	Recruiting
Clinical Research Site	Stockbridge	Georgia	Recruiting
Clinical Research Site	Skokie	Illinois	Recruiting
Clinical Research Site	Evansville	Indiana	Recruiting
Clinical Research Site	Kansas City	Missouri	Recruiting
Clinical Research Site	Brooklyn	New York	Recruiting
Clinical Research Site	Knoxville	Tennessee	Recruiting
Clinical Research Site	Memphis	Tennessee	Recruiting
Clinical Research Site	Austin	Texas	Recruiting
Clinical Research Site	Fort Worth	Texas	Recruiting
Clinical Research Site	Newport News	Virginia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766655 on ClinicalTrials.gov ↗ ← All trials in the USA