A Phase 3 interventional study of AXS-05 (dextromethorphan-bupropion) and Bupropion in Smoking Cessation, sponsored by Axsome Therapeutics, Inc.. Recruiting at 28 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 705 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Up to 12 weeks
Drug: AXS-05 (dextromethorphan-bupropion)
Up to 12 weeks
Drug: Bupropion
Up to 12 weeks
Drug: Placebo
AXS-05 tablets, taken twice daily for 12 weeks.
Bupropion tablets, taken twice daily for 12 weeks.
Placebo tablets, taken twice daily for 12 weeks.
4-Week Continuous Smoking Abstinence Rate
Time frame: Weeks 9 to 12
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
Of 31 phase 3 interventional studies under Smoking Cessation, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Dextromethorphan/Bupropion Tablet AXS-05 · Bupropion