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

Axsome Therapeutics, Inc.

Summary

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

Age range: 18–65 years
Sex: All
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.

Interventions

Drug
AXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily for 12 weeks.
Drug
Bupropion
Bupropion tablets, taken twice daily for 12 weeks.
Drug
Placebo
Placebo tablets, taken twice daily for 12 weeks.

Locations (16)

Clinical Research Site
Little Rock, Arkansas
Clinical Research Site
Lemon Grove, California
Clinical Research Site
Pomona, California
Clinical Research Site
DeLand, Florida
Clinical Research Site
Jacksonville, Florida
Clinical Research Site
Orlando, Florida