A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
ConditionSmoking Cessation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
Male or female, aged 18 to 65 (inclusive)
Disqualifiers
Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.
Trial design
Treatments tested in this trial
- AXS-05 (dextromethorphan-bupropion)
- Bupropion
- Placebo
Treatment groups
705 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov