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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

705

participants targeted

Target at P75+ for phase_3

Timeline

16mo left

Started Aug 2026

Shorter than P25 for phase_3

Geographic Reach

1 country

9 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Progress3%

Aug 2026Dec 2027

Study Start

First participant enrolled

August 1, 2026

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 11, 2026

Last Update Submit

August 11, 2026

Conditions

Smoking Cessation

Keywords

Smoking cessationSmokingCigarettesAXS-05AuvelityAxsome TherapeuticsDopamine reuptake inhibitorNorepinephrine reuptake inhibitorDextromethorphanBupropionNMDA Receptor AntagonistGlutamate ModulatorSigma-1 Receptor AgonistNicotinic Acetylcholine Receptor Antagonist

Outcome Measures

Primary Outcomes (1)

4-Week Continuous Smoking Abstinence Rate
Weeks 9 to 12

Study Arms (3)

AXS-05

EXPERIMENTAL

Up to 12 weeks

Drug: AXS-05 (dextromethorphan-bupropion)

Bupropion

EXPERIMENTAL

Up to 12 weeks

Drug: Bupropion

Placebo

PLACEBO COMPARATOR

Up to 12 weeks

Drug: Placebo

Interventions

AXS-05 (dextromethorphan-bupropion)DRUG

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

AXS-05

BupropionDRUG

Bupropion tablets, taken twice daily for 12 weeks.

Bupropion

PlaceboDRUG

Placebo tablets, taken twice daily for 12 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, aged 18 to 65 (inclusive)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Axsome Therapeutics, Inc.lead

Study Sites (9)

Clinical Research Site

Little Rock, Arkansas, 772211, United States

RECRUITING

Clinical Research Site

Jacksonville, Florida, 32256, United States

RECRUITING

Clinical Research Site

Orlando, Florida, 32801, United States

RECRUITING

Clinical Research Site

Stockbridge, Georgia, 30281, United States

RECRUITING

Clinical Research Site

Kansas City, Missouri, 64114, United States

RECRUITING

Clinical Research Site

Brooklyn, New York, 11235, United States

RECRUITING

Clinical Research Site

Knoxville, Tennessee, 37909, United States

RECRUITING

Clinical Research Site

Memphis, Tennessee, 38119, United States

RECRUITING

Clinical Research Site

Newport News, Virginia, 23606, United States

RECRUITING

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Central Study Contacts

Study Director

CONTACT

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

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 14, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Locations

US(9)

A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

AXS-05

Bupropion

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

AXS-05

Bupropion

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations