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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AXS-05 		Up to 12 weeks
  • Drug: AXS-05 (dextromethorphan-bupropion)
    AXS-05 tablets, taken twice daily for 12 weeks.
Experimental
Bupropion 		Up to 12 weeks
  • Drug: Bupropion
    Bupropion tablets, taken twice daily for 12 weeks.
Placebo Comparator
Placebo 		Up to 12 weeks
  • Drug: Placebo
    Placebo tablets, taken twice daily for 12 weeks.

Recruiting Locations

Clinical Research Site
Little Rock, Arkansas 772211

Clinical Research Site
Jacksonville, Florida 32256

Clinical Research Site
Orlando, Florida 32801

Clinical Research Site
Stockbridge, Georgia 30281

Clinical Research Site
Kansas City, Missouri 64114

Clinical Research Site
Brooklyn, New York 11235

Clinical Research Site
Knoxville, Tennessee 37909

Clinical Research Site
Memphis, Tennessee 38119

Clinical Research Site
Newport News, Virginia 23606

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
212-332-5061
AXS-05-SC-301@axsome.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.