Recruiting
Phase 3

AXS-05

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT07766655

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

AXS-05 (dextromethorphan-bupropion)

Bupropion

Placebo

Study Details

Brief 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.

Conditions

Smoking Cessation

Study ID

NCT07766655

Start date

Aug 27, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

705 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AXS-05

Up to 12 weeks

experimental: Bupropion

Up to 12 weeks

placebo comparator: Placebo

Up to 12 weeks

Interventions

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.

Primary outcome measure

  • 4-Week Continuous Smoking Abstinence Rate [ Time Frame: Weeks 9 to 12 ]

Central Contacts and Locations

Central contacts

Study Director

212-332-5061AXS-05-SC-301@axsome.com

Locations

Clinical Research Site

Recruiting

Little Rock, Arkansas, United States, 72211

Clinical Research Site

Recruiting

Lemon Grove, California, United States, 91945

Clinical Research Site

Recruiting

Long Beach, California, United States, 90806

Clinical Research Site

Recruiting

Pomona, California, United States, 91767

Clinical Research Site

Recruiting

DeLand, Florida, United States, 32720

Clinical Research Site

Recruiting

Jacksonville, Florida, United States, 32256

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32801

Clinical Research Site

Recruiting

Tampa, Florida, United States, 33614

Clinical Research Site

Recruiting

Columbus, Georgia, United States, 31901

Clinical Research Site

Recruiting

Stockbridge, Georgia, United States, 30281

Clinical Research Site

Recruiting

Skokie, Illinois, United States, 60077

Clinical Research Site

Recruiting

Evansville, Indiana, United States, 47714

Clinical Research Site

Recruiting

Kansas City, Missouri, United States, 64114

Clinical Research Site

Recruiting

Brooklyn, New York, United States, 11229

Clinical Research Site

Recruiting

Brooklyn, New York, United States, 11235

Clinical Research Site

Recruiting

Rochester, New York, United States, 14609

Clinical Research Site

Recruiting

Duncansville, Pennsylvania, United States, 16635

Clinical Research Site

Recruiting

North Charleston, South Carolina, United States, 29405

Clinical Research Site

Recruiting

Knoxville, Tennessee, United States, 37909

Clinical Research Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Clinical Research Site

Recruiting

Austin, Texas, United States, 78705

Clinical Research Site

Recruiting

Dallas, Texas, United States, 75251

Clinical Research Site

Recruiting

Fort Worth, Texas, United States, 76135

Clinical Research Site

Recruiting

Huston, Texas, United States, 77061

Clinical Research Site

Recruiting

Newport News, Virginia, United States, 23606

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Smoking cessation
  • Smoking
  • Cigarettes
  • AXS-05
  • Auvelity
  • Axsome Therapeutics
  • Dopamine reuptake inhibitor
  • Norepinephrine reuptake inhibitor
  • Dextromethorphan
  • Bupropion
  • NMDA Receptor Antagonist
  • Glutamate Modulator
  • Sigma-1 Receptor Agonist
  • Nicotinic Acetylcholine Receptor Antagonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.