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

A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Registry ID
NCT07766655
Source registry
NCT
Status
RECRUITING
Phase
PHASE3
Study type
INTERVENTIONAL
Sponsor
Axsome Therapeutics, Inc.
Enrollment
705
Start date
2026-08-01
Completion date
2027-12-01
Last update
2026-08-14

Conditions

Summary

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.

Detailed description

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.

Interventions

Inclusion criteria

Inclusion Criteria: * Male or female, aged 18 to 65 (inclusive)

Exclusion criteria

Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

Primary outcomes

[{"measure":"4-Week Continuous Smoking Abstinence Rate","timeFrame":"Weeks 9 to 12"}]

Locations

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