Smoking Cessation
Conditions
Keywords
Smoking cessation, Smoking, Cigarettes, AXS-05, Auvelity, Axsome Therapeutics, Dopamine reuptake inhibitor, Norepinephrine reuptake inhibitor, Dextromethorphan, Bupropion, NMDA Receptor Antagonist, Glutamate Modulator, Sigma-1 Receptor Agonist, Nicotinic Acetylcholine Receptor Antagonist
Brief 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.
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.
Interventions
AXS-05 tablets, taken twice daily for 12 weeks.
DRUGBupropion
Bupropion tablets, taken twice daily for 12 weeks.
DRUGPlacebo
Placebo tablets, taken twice daily for 12 weeks.
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4-Week Continuous Smoking Abstinence Rate | Weeks 9 to 12 |
Countries
United States
Contacts
CONTACTStudy Director
Outcome results
None listed