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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

NCT07766655

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Smoking Cessation

Interventions: AXS-05 (dextromethorphan-bupropion), Bupropion, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (9)
  • Little Rock, Arkansas, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Stockbridge, Georgia, United States
  • Kansas City, Missouri, United States
  • Brooklyn, New York, United States
  • Knoxville, Tennessee, United States
  • Memphis, Tennessee, United States
  • Newport News, Virginia, United States