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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
705
Clinical Research Site
Little Rock, Arkansas, United States
RECRUITINGClinical Research Site
Lemon Grove, California, United States
4-Week Continuous Smoking Abstinence Rate
Time frame: Weeks 9 to 12
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Clinical Research Site
Pomona, California, United States
RECRUITINGClinical Research Site
DeLand, Florida, United States
RECRUITINGClinical Research Site
Jacksonville, Florida, United States
RECRUITINGClinical Research Site
Orlando, Florida, United States
RECRUITINGClinical Research Site
Stockbridge, Georgia, United States
RECRUITINGClinical Research Site
Skokie, Illinois, United States
RECRUITINGClinical Research Site
Evansville, Indiana, United States
RECRUITINGClinical Research Site
Kansas City, Missouri, United States
RECRUITING...and 6 more locations