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NCT07766655PHASE3Recruiting

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

Axsome Therapeutics, Inc.

Start Date

8/27/2026

Completion Date

12/1/2027

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.

Detailed Description

Eligible subjects will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 12 weeks, followed by an 18-week follow-up period.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

DRUG

AXS-05 (dextromethorphan-bupropion)

DRUG

Bupropion

DRUG

Placebo

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Conditions

Smoking Cessation

Locations

Clinical Research Site

Little Rock, Arkansas 72211

United States

Clinical Research Site

Lemon Grove, California 91945

United States

Clinical Research Site

Long Beach, California 90806

United States

Clinical Research Site

Pomona, California 91767

United States

Clinical Research Site

DeLand, Florida 32720

United States

Clinical Research Site

Jacksonville, Florida 32256

United States

Clinical Research Site

Orlando, Florida 32801

United States

Clinical Research Site

Tampa, Florida 33614

United States

Clinical Research Site

Columbus, Georgia 31901

United States

Clinical Research Site

Stockbridge, Georgia 30281

United States

Clinical Research Site

Skokie, Illinois 60077

United States

Clinical Research Site

Evansville, Indiana 47714

United States

Clinical Research Site

Kansas City, Missouri 64114

United States

Clinical Research Site

Brooklyn, New York 11229

United States

Clinical Research Site

Brooklyn, New York 11235

United States

Clinical Research Site

Rochester, New York 14609

United States

Clinical Research Site

Duncansville, Pennsylvania 16635

United States

Clinical Research Site

North Charleston, South Carolina 29405

United States

Clinical Research Site

Knoxville, Tennessee 37909

United States

Clinical Research Site

Memphis, Tennessee 38119

United States

Clinical Research Site

Nashville, Tennessee 37203

United States

Clinical Research Site

Austin, Texas 78705

United States

Clinical Research Site

Dallas, Texas 75251

United States

Clinical Research Site

Fort Worth, Texas 76135

United States

Clinical Research Site

Huston, Texas 77061

United States

Clinical Research Site

Newport News, Virginia 23606

United States