A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Axsome Therapeutics, Inc.
Study ID
NCT07766655
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AXS-05 (dextromethorphan-bupropion) — DRUG
    AXS-05 tablets, taken twice daily for 12 weeks.
  • Bupropion — DRUG
    Bupropion tablets, taken twice daily for 12 weeks.
  • Placebo — DRUG
    Placebo tablets, taken twice daily for 12 weeks.

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
705 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AXS-05
    Up to 12 weeks
  • Experimental: Bupropion
    Up to 12 weeks
  • Placebo Comparator: Placebo
    Up to 12 weeks

Primary Outcome Measure

4-Week Continuous Smoking Abstinence Rate [ Time Frame: Weeks 9 to 12 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Clinical Research SiteLittle RockArkansas772211-
Clinical Research SiteJacksonvilleFlorida32256-
Clinical Research SiteOrlandoFlorida32801-
Clinical Research SiteStockbridgeGeorgia30281-
Clinical Research SiteKansas CityMissouri64114-
Clinical Research SiteBrooklynNew York11235-
Clinical Research SiteKnoxvilleTennessee37909-
Clinical Research SiteMemphisTennessee38119-
Clinical Research SiteNewport NewsVirginia23606-

Related Studies