Smoking CessationPhase 3SUMMITNCT07766655
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
A Phase 3 study testing AXS-05 (dextromethorphan-bupropion) and Bupropion in people with Smoking Cessation, run by Axsome Therapeutics, Inc. at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- AXS-05 (dextromethorphan-bupropion) and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 705 participants
- Where
- 28 sitesUnited States
- Study dates
- 27 Aug 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 (inclusive)
Who cannot join
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 28 recruiting
- Recruiting
Clinical Research Site
Austin, Texas, 78705
- Recruiting
Clinical Research Site
Brooklyn, New York, 11229
- Recruiting
Clinical Research Site
Brooklyn, New York, 11235
- Recruiting
Clinical Research Site
Columbus, Georgia, 31901
- Recruiting
Clinical Research Site
Dallas, Texas, 75251
- Recruiting
Clinical Research Site
DeLand, Florida, 32720
- Recruiting
Clinical Research Site
Duncansville, Pennsylvania, 16635
- Recruiting
Clinical Research Site
Evansville, Indiana, 47714
- Recruiting
Clinical Research Site
Fort Worth, Texas, 76135
- Recruiting
Clinical Research Site
Huston, Texas, 77061
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Kansas City, Missouri, 64114
- Recruiting
Clinical Research Site
Knoxville, Tennessee, 37909
- Recruiting
Clinical Research Site
Lemon Grove, California, 91945
- Recruiting
Clinical Research Site
Little Rock, Arkansas, 72211
- Recruiting
Clinical Research Site
Long Beach, California, 90806
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Recruiting
Clinical Research Site
Mount Airy, North Carolina, 27030
- Recruiting
Clinical Research Site
Nashville, Tennessee, 37203
- Recruiting
Clinical Research Site
Newport News, Virginia, 23606
- Recruiting
Clinical Research Site
North Charleston, South Carolina, 29405
- Recruiting
Clinical Research Site
Orlando, Florida, 32801
- Recruiting
Clinical Research Site
Phoenix, Arizona, 85032
- Recruiting
Clinical Research Site
Pomona, California, 91767
- Recruiting
Clinical Research Site
Rochester, New York, 14609
- Recruiting
Clinical Research Site
Skokie, Illinois, 60077
- Recruiting
Clinical Research Site
Stockbridge, Georgia, 30281
- Recruiting
Clinical Research Site
Tampa, Florida, 33614
About this study
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
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- AXS-05 (dextromethorphan-bupropion), Bupropion, Placebo
- 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
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-05 (dextromethorphan-bupropion)Drug
AXS-05 tablets, taken twice daily for 12 weeks.
BupropionDrug
Bupropion tablets, taken twice daily for 12 weeks.
PlaceboDrug
Placebo tablets, taken twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AXS-05 | Experimental | Up to 12 weeks Receives: Drug: AXS-05 (dextromethorphan-bupropion) |
| Bupropion | Experimental | Up to 12 weeks Receives: Drug: Bupropion |
| Placebo | Placebo comparator | Up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Week Continuous Smoking Abstinence Rate
Measured: Weeks 9 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start27 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 705 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766655
- Sponsor's protocol ID
- AXS-05-SC-301
- Acronym
- SUMMIT
- Status last verified
- Nov 2026
- First submitted
- 11 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07766655
- Acronym / sponsor ID
- SUMMIT / AXS-05-SC-301
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Smoking, Cigarettes, AXS-05, Auvelity, Axsome Therapeutics, Dopamine reuptake inhibitor, Norepinephrine reuptake inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 705 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AXS-05 | Experimental | Drug: AXS-05 (dextromethorphan-bupropion)Up to 12 weeks |
| Bupropion | Experimental | Drug: BupropionUp to 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female, aged 18 to 65 (inclusive)
Key exclusion criteria (2 listed)
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-05 (dextromethorphan-bupropion)AXS-05 tablets, taken twice daily for 12 weeks. | Drug | AXS-05 |
| BupropionBupropion tablets, taken twice daily for 12 weeks. | Drug | Bupropion |
| PlaceboPlacebo tablets, taken twice daily for 12 weeks. | Drug | Placebo |
Primary outcome
4-Week Continuous Smoking Abstinence Rate
Time frame: Weeks 9 to 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-05 (dextromethorphan-bupropion) and Bupropion in people with Smoking Cessation, run by Axsome Therapeutics, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (212-332-5061, AXS-05-SC-301@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-Week Continuous Smoking Abstinence Rate (time frame: Weeks 9 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.