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Can a Two-Drug combo break the smoking habit?

NCT ID NCT07766655

Disease control Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This clinical trial is testing whether an experimental medication called AXS-05, which combines dextromethorphan and bupropion, can help adults quit smoking. The study will compare AXS-05 against a placebo and an existing smoking cessation drug, bupropion, to see which is more effective. Participants will take the medication twice daily for 12 weeks, and the main goal is to measure continuous smoking abstinence over a 4-week period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AXS-05, a combination of dextromethorphan and bupropion, taken as tablets twice daily for 12 weeks.
What this could lead to
If successful, this could provide a new, more effective medication option to help people quit smoking and reduce the health risks associated with tobacco use.
What could go wrong
This is a Phase 3 trial, but results are not guaranteed. The treatment may not prove more effective than existing options, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 705 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Smoking Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoking cessation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Site

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Clinical Research Site

    RECRUITING

    Pomona, California, 91767, United States

  • Clinical Research Site

    RECRUITING

    DeLand, Florida, 32720, United States

  • Clinical Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Site

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Clinical Research Site

    RECRUITING

    Evansville, Indiana, 47714, United States

  • Clinical Research Site

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • Clinical Research Site

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Clinical Research Site

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Clinical Research Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    RECRUITING

    Austin, Texas, 78705, United States

  • Clinical Research Site

    RECRUITING

    Fort Worth, Texas, 76135, United States

  • Clinical Research Site

    RECRUITING

    Newport News, Virginia, 23606, United States

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