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NCT Number: NCT07766655

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 4-Week Continuous Smoking Abstinence Rate

    Time frame: Weeks 9 to 12

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

212-332-5061

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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