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

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

Recruiting
18-65 years
All
Phase 3
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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Male or female, aged 18 to 65 (inclusive)

Exclusion Criteria:

  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Study details
    Smoking Cessation

NCT07766655

Axsome Therapeutics, Inc.

15 August 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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