Can a Two-Drug combo break the smoking habit?

NCT ID NCT07766655

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

First seen Aug 14, 2026 · Last updated Aug 14, 2026

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.

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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

Contacts and locations

Locations

Clinical Research Site
RECRUITING

Little Rock, Arkansas, 772211, United States
Clinical Research Site
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Jacksonville, Florida, 32256, United States
Clinical Research Site
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Orlando, Florida, 32801, United States
Clinical Research Site
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Stockbridge, Georgia, 30281, United States
Clinical Research Site
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Kansas City, Missouri, 64114, United States
Clinical Research Site
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Brooklyn, New York, 11235, United States
Clinical Research Site
RECRUITING

Knoxville, Tennessee, 37909, United States
Clinical Research Site
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Memphis, Tennessee, 38119, United States
Clinical Research Site
RECRUITING

Newport News, Virginia, 23606, United States

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