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RECRUITING
NCT07766655
PHASE3

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

Sponsor: Axsome Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

AXS-05 (dextromethorphan-bupropion)

AXS-05 tablets, taken twice daily for 12 weeks.

DRUG

Bupropion

Bupropion tablets, taken twice daily for 12 weeks.

DRUG

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