A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
← catalyst calendarNCT07766655 · readout ≤ 499 d
Sponsored by Axsome Therapeutics, Inc. (industry) · AXSM — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
705estimated
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Aug 2026 | estimated | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Smoking Cessation
Interventions
- Drug: AXS-05 (dextromethorphan-bupropion)
- Drug: Bupropion
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OF4-Week Continuous Smoking Abstinence Rate
measured Weeks 9 to 12
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